Improvement on blood pressure and skin using roselle drink: A clinical trial.

Roselle (Hibiscus sabdariffa L.) is an increasingly attractive plant for its health and pharmaceutical, beverage, and cosmetic applications. The purpose of this study was to investigate the clinical effects of roselle drink on antioxidant activity, blood pressure, and skin condition. Roselle drink used in this study contained rich phenolics (1.96 g of gallic acid equivalent/100 ml) and anthocyanins (1.65 g of cyanidin-3-glucoside equivalent/100 ml). In a randomized, cross-over, double-blind, placebo-controlled clinical study, 39 healthy adults received drank 200 ml of roselle drink or placebo-control drink for 6 months. A significant reduction in the blood pressure was observed in the roselle drink treated group when compared with preintervention values. After 6 months of treatment with roselle drink, serum phenolics contents, the levels of Trolox equivalent antioxidant capacity (TEAC), glutathione, superoxide dismutase (SOD), glucose-6-phosphate dehydrogenase (G-6-PDH), glutathione peroxidase (GSH-Px), and glutathione reductase (GSH-Rd) were significantly increased in healthy subjects. However, a significant increment in skin redness and skin moisture was observed in the facial skin of roselle drink-treated participants. Oral administration of roselle drink for 6 months significantly lowered the blood pressure, improved antioxidation level, and positively regulated skin redness as well as moisture. Phenolics and anthocyanins in roselle could be the major potential contributors to such health effects. PRACTICAL APPLICATIONS: Roselle is a typical plant. Continuous administration of roselle drink clearly improved antioxidation levels, reduced blood pressure and positively regulated skin redness and moisture. Phenloics and anthocyanins in roselle could be the major potentila contributors of such health benefits.

The effect of sumac (Rhus coriaria L.) supplementation on glycemic indices: A systematic review and meta-analysis of controlled clinical trials.

BACKGROUND & AIMS: Rhus coriaria L. (Sumac) is a popular spice/herb with several biological functions owing to its antioxidant and insulin-like activities. Many clinical trials have indicated the potent anti-diabetic property of sumac but the results on few glycemic indices were inconclusive. Hence, this systematic review and meta-analysis were aimed to investigate sumac supplementation effect on glycemic indices. METHODS: Systematically searched was performed by two independent reviewers using online databases including: PubMed, Scopus, web of science, EMBASE from inception until November 2020. Data were pooled using a random-effects model and weighted mean difference (WMD) with 95 % confidence intervals (CI). RESULTS: A total of 6 potentially relevant clinical trials met the inclusion criteria with total of 278 participants. Random-effects meta-analysis suggested no significant effects on the levels of fasting blood glucose [-7.08 mg/dl, 95 % CI: -14.85 to 0.70,P = 0.07, I2 = 59.8 %], glycosylated hemoglobin (HbA1c) [-0.48 %, 95 % CI: -1.01 to -0.04, P = 0.07, I2 = 0.0 %], homeostatic model assessment for insulin resistance (HOMA-IR) [-0.97, 95 % CI: -1.96 to 0.02, P = 0.05, I2 = 83.8 %], and insulin [-2.94 Hedges' g, 95 % CI: -6.67 to 0.80, P = 0.12, I2 = 83.1 %] following supplementation with sumac powder. CONCLUSION: This meta-analysis showed no significant effects on any glycemic indices following supplementation with sumac powder.

Gastroprotective Effects of Polyphenols against Various Gastro-Intestinal Disorders: A Mini-Review with Special Focus on Clinical Evidence.

Polyphenols are classified as an organic chemical with phenolic units that display an array of biological functions. However, polyphenols have very low bioavailability and stability, which make polyphenols a less bioactive compound. Many researchers have indicated that several factors might affect the efficiency and the metabolism (biotransformation) of various polyphenols, which include the gut microbiota, structure, and physical properties as well as its interactions with other dietary nutrients (macromolecules). Hence, this mini-review covers the two-way interaction between polyphenols and gut microbiota (interplay) and how polyphenols are metabolized (biotransformation) to produce various polyphenolic metabolites. Moreover, the protective effects of numerous polyphenols and their metabolites against various gastrointestinal disorders/diseases including gastritis, gastric cancer, colorectal cancer, inflammatory bowel disease (IBD) like ulcerative colitis (UC), Crohn's disease (CD), and irritable bowel syndrome (IBS) like celiac disease (CED) are discussed. For this review, the authors chose only a few popular polyphenols (green tea polyphenol, curcumin, resveratrol, quercetin), and a discussion of their proposed mechanism underpinning the gastroprotection was elaborated with a special focus on clinical evidence. Overall, this contribution would help the general population and science community to identify a potent polyphenol with strong antioxidant, anti-inflammatory, anti-cancer, prebiotic, and immunomodulatory properties to combat various gut-related diseases or disorders (complementary therapy) along with modified lifestyle pattern and standard gastroprotective drugs. However, the data from clinical trials are much limited and hence many large-scale clinical trials should be performed (with different form/metabolites and dose) to confirm the gastroprotective activity of the above-mentioned polyphenols and their metabolites before recommendation.

Beneficial effect of Chlorella pyrenoidosa drink on healthy subjects: A randomized, placebo-controlled, double-blind, cross-over clinical trial.

The current study aims to explore the anti-inflammatory activity of Chlorella pyrenoidosa on RAW 267.4 cells and followed by a cross-over clinical trial in healthy subjects to check the antioxidant and anti-aging properties of Chlorella water extract (CWE). For the clinical trial, 44 healthy subjects were requested to consume 27 ml of either placebo or CWE for 90 days (phase I) and vice-versa manner for 90 days (phase II) with 4 weeks of washout period. The RAW 264.7 macrophages treated with Chlorella display potent anti-inflammatory activity by significantly downregulating (p < .05) the protein expressions of inducible nitric oxide synthase (iNOS) and cyclooxygenase-2 (COX-2). Whereas, the subjects supplemented with CWE showed improved (p < .05) antioxidant status (TEAC, SOD, CAT, and DHEAs) and lower (p < .05) oxidative stress/aging markers (TBARS and 8-OHdG) as well as considerably (p < .05) protected liver (by lowering GOT and GPT). Thus, consumption of chlorella could significantly improve the overall health status by suppressing various oxidative stress markers and aging stress markers. PRACTICAL APPLICATIONS: Chlorella is considered as a popular functional food owing to its rich nutrient value and its array of biological activities. Numerous studies indicated that treatment with Chlorella spp. would considerably lower oxidative stress, inflammation, and regulate immune response which might contribute to anti-aging property in various cell and animal models. Based on the above information, we expected that Chlorella would be a better contender for the development of a novel anti-aging agent. Hence, we designed this clinical trial to assess the beneficial effects of Chlorella pyrenoidosa especially anti-aging. In agreement with our hypothesis, our results also showed that subjected supplemented with Chlorella water extract could significantly improve overall health status by suppressing various oxidative stress markers and aging stress markers. Hence, Chlorella could be developed into a novel anti-aging agent. In the future, it can be prescribed with standard anti-aging agents to improve the overall health status of the elderly population. However, large-scale clinical studies are needed to confirm our statements.

Impact of Micronutrients on Hypertension: Evidence from Clinical Trials with a Special Focus on Meta-Analysis.

Hypertension (HT) is one of the pivotal risk factors for various detrimental diseases like cardiovascular diseases (CVDs), cerebrovascular disease, and renal dysfunction. Currently, many researchers are paying immense attention to various diet formula (dietary approach) with a special focus on micro and macronutrients along with modified lifestyle and standard anti-hypertensive drugs. Micronutrients (minerals/vitamins) play a central role in the regulation of blood pressure (BP) as they aid the function of macronutrients and also improve the anti-hypertensive functions of some anti-hypertensive agents. Even though several studies have demonstrated the beneficial effects of micronutrients on controlling BP, still some ambiguity exists among the nutritionists/doctors, which combination or individual mineral (dietary approach) contributes to better BP regulation. Therefore, this critical review article was attempted to delineate the underlying role of micronutrients (minerals and vitamins) for the management and prevention or delaying of HT and their related complications with strong affirmation from clinical trials as well as its mechanism of controlling BP. Moreover, the major source and recommended daily allowance (RDA) of various micronutrients are included in this review for guiding common readers (especially HT subjects) and dieticians to choose/recommend a better micronutrient and their combinations (other nutrients and standard anti-hypertensive drugs) for lowering the risk of HT and its related co-morbid conditions like CVDs.

Efficacy of Probiotic Milk Formula on Blood Lipid and Intestinal Function in Mild Hypercholesterolemic Volunteers: A Placebo-control, Randomized Clinical Trial.

Several studies have reported that probiotics could modulate host lipid metabolism via altering the intestinal microbiota. Hence, the current study was aimed to assess the efficacy of a mixture of probiotic-contained milk formula (PMF) with three different bacterial strains [Lactobacillus acidophilus (La5), Lactobacillus casei (TMC), Bifidobacterium lactis (Bb12)] on lipid profile and intestinal function in healthy mild hypercholesterolemic volunteers. Totally, 40 healthy mild hypercholesterolemic subjects (180-220 mg/dL) were randomly assigned into two groups as placebo or experimental group. All the subjects were requested to drink either PMF (experimental) or skimmed milk drink formula-placebo (30 g mixed with 200 mL of water) for 10 weeks and continued by 2 weeks of the follow-up period. Supplementation of PMF for 10 weeks significantly improved (p < 0.05) the fecal weight, fecal movement (decreased fecal gastrointestinal passing time) by improving intestinal microbiota (increasing beneficial bacterial species like Lactobacillus, Bifidobacterium spp.), and lag time of low-density lipoprotein (LDL) oxidation. Also, intake of PMF substantially reduced (p < 0.05) the levels of total cholesterol (TC; 8.1%) and low-density lipoprotein cholesterol (LDL-c; 10.4%) and thus showcasing its cardioprotective efficacy. PMF considerably improves gastrointestinal function by modulating fecal movement, intestinal microbiota, and decrease cholesterol and might be helpful in the management of hypercholesterolemia.

The effects of supplementation with Cynara scolymus L. on anthropometric indices: А systematic review and dose-response meta-analysis of clinical trials.

BACKGROUND: Studies on the efficacy of artichoke administration on anthropometric indices gave different outcomes. Hence, a systematic review and dose-response meta-analysis were accomplished to understand the effects of artichoke administration on anthropometric indices. METHODS: Related clinical trials were found by searching in PubMed, Embase, the Cochrane Library and Scopus databases up to 29 February 2020. Weighted Mean Differences (WMD) were analyzed using a random-effects model. Heterogeneity, publication bias and sensitivity analysis were assessed for anthropometric indices. RESULTS: Pooled analysis of 10 randomized controlled trials (RCTs) suggested that the artichoke administration has effect on waist circumference (WMD: -1.11 cm, 95 % CI: -2.08 to - 0.14), as opposed to the other anthropometric indices including weight (WMD: -0.62 kg, 95 % CI: -1.86 to 0.61) or BMI (WMD: -0.12, 95 % CI: -0.43 to 0.20). However, the analysis of the subgroups according to the health status showed that artichoke supplementation in hypertensive patients significantly reduced weight (WMD: -2.34 kg, 95 % CI: -3.11 to -1.57) but not the other indicators (WMD: -0.06 kg, 95 % CI: 0.78 to 0.67). CONCLUSIONS: The artichoke supplementation has effect on the waist circumference, but not on the other anthropometric indices. For establishment of more accurate conclusion more studies with longer administration duration are need to be done.

Effects of pistachios on anthropometric indices, inflammatory markers, endothelial function and blood pressure in adults: a systematic review and meta-analysis of randomised controlled trials.

Evidence suggests that eating nuts may reduce the risk of CVD. This study was intended to pool the data of all randomised controlled trials (RCT) available to determine if pistachios confer a beneficial effect on anthropometric indices, inflammatory markers, endothelial dysfunction and blood pressure. Without language restriction, PubMed, Scopus, Cochrane Library and Web of Science were searched for articles published from the earliest records to June 2019 investigating the effect of pistachio consumption on inflammation, endothelial dysfunction and hypertension. Mean difference (MD) was pooled using a random effects model. The Cochrane risk of bias tool was used to evaluate the quality of the studies. The meta-analysis of thirteen RCT with 563 participants indicated that pistachio consumption significantly decreased systolic blood pressure (SBP) (MD: -2·12 mmHg, 95 % CI -3·65, -0·59, P = 0·007), whereas changes in flow-mediated dilation (MD: 0·94 %, 95 % CI -0·99, 2·86, P = 0·813), diastolic blood pressure (MD: 0·32 mmHg, 95 % CI -1·37, 2·02, P = 0·707), C-reactive protein (MD: 0·00 mg/l, 95 % CI -0·21, 0·23, P = 0·942), TNF-α (MD: -0·09 pg/ml, 95 % CI -0·38, 0·20, P = 0·541), body weight (MD: 0·09 kg, 95 % CI -0·38, 0·69, P = 0·697), BMI (MD: 0·07 kg/m2, 95 % CI -0·16, 0·31, P = 0·553) and waist circumference (MD: 0·77 cm, 95 % CI -0·09, 1·64, P = 0·140) were not statistically significant. This systematic review and meta-analysis suggested the efficacy of pistachio consumption to reduce SBP levels. However, further large-scale studies are needed to confirm these results.

The role of nutraceuticals as a complementary therapy against various neurodegenerative diseases: A mini-review.

In recent times, many scientists have given great attention to nutraceuticals (complementary medicine) as it widely used for promoting health status. In particular for the prevention and treatment of various neurological diseases or disorders without or less adverse effects. The current mini-review was intended to compile all popular (major) nutraceuticals against various neurodegenerative diseases (NDDs) including Parkinson's disease (PD), Alzheimer's disease (AD), Huntington's disease (HD) with special reference to clinical trials. Preliminary reviews indicated that nutraceuticals like curcumin, resveratrol, Epigallocatechin-3-gallate (EGCG), Coenzyme Q10, ω-3 FA (DHA/EPA/ALA), showed better neuroprotective activity against various NDDs in human setting (clinical trial). Hence this contribution will focus only on those popular nutraceuticals with proposed brief mechanisms (antioxidant, anti-inflammatory, mitochondrial homeostasis, autophagy regulation, promote neurogenesis) and its recommendation. This mini-review would aid common people to choose better nutraceuticals to combat various NDDs along with standard neuroprotective agents and modified lifestyle pattern.

Chemopreventive and Chemotherapeutic Effect of Propolis and Its Constituents: A Mini-review.

Propolis is a bee wax rich in various phytocomponents and traditionally used to treat various ailments. Propolis is reported to possess an array of biological properties including anti-inflammatory, antioxidant, anti-cancer, and anti-diabetic as well as cardioprotective, hepatoprotective, renoprotective, and derma protective activities. A plethora of studies confirmed that propolis is effective against various types of cancer including head and neck, lung, liver, brain (glioma), pancreas, kidney, prostate, skin (melanoma), breast, oral, esophagus, gastric, colorectal, and bladder cancers. However, many researchers have demonstrated that propolis displays potent chemoprotective/chemopreventive or anti-cancer activity against only a few types of cancers like oral, gastrointestinal, dermal (melanoma), breast, and prostate cancers. Therefore, this mini-review only summarizes the chemopreventive/chemotherapeutic activities of propolis and its updated underlying mechanisms. Taken together, propolis displays potent chemoprotective or anti-cancer effect due to the presence of various phytocomponents which contribute to pro-apoptotic, cytotoxic, anti-proliferative (cell cycle arrest), anti-metastatic, anti-invasive, anti-angiogenic and anti-genotoxic or anti-mutagenic properties along with antioxidant, immunomodulatory, and anti-inflammatory functions. Hence, propolis could be used as an adjuvant for treating various cancers along with standard chemotherapeutic drugs. However, many large-scale clinical studies are needed to justify such applications.

Improved bioavailability of EGCG after complexation with royal jelly protein.

This study was designed to check whether complexation of royal jelly (RJ) proteins with green tea extract enriched with EGCG, would enhance the bioavailability on C2BBe1 cells. The total phenolic and EGCG of green tea extract (GTex) as well as the protein level of RJ were measured. The best entrapment efficiency (30.47%) was noted at a 10:4 ratio (RJ:EGCG of GTex) to confirm the maximum EGCG-RJ complexation. Followed by in vitro studies to check the cytotoxicity, morphological changes, EGCG uptake, and TBARS (antioxidant) activity were evaluated on C2BBe1 cells. The EGCG-RJ protein complex showed less toxicity without any morphological changes with better cellular EGCG uptake than GTex or GTex-RJ mixture on CeBBe1 cells. Besides, the EGCG-RJ protein complex display maximum TBARS suppressing activity to showcase better stability. This study infers that complexation of RJ proteins with EGCG (EGCG-RJ protein complex) could significantly improve the bioavailability of EGCG. PRACTICAL APPLICATIONS: EGCG is the major active component of green tea, which is responsible for various biological functions. Previous studies have indicated that complexation of EGCG with proteins (act as a carrier) could considerably improve the bioavailability of EGCG. Hence, the author speculates that complexation or combination of RJ with green tea (EGCG), might improve the bioavailability as well as enhance its biological properties. The outcome of this cell line study showed that the EGCG-RJ protein complex showed better bioavailability than EGCG or GTex, and thus, indicating that this novel complex can be used in the future for better EGCG bioavailability with improved biological function. However, further studies are needed to confirm the types of interaction and the reason for better bioavailability.

Impact of functional foods and nutraceuticals on high blood pressure with a special focus on meta-analysis: review from a public health perspective.

In recent times many researchers are expressing immense interest in nutraceuticals and functional foods for combating various diseases or abnormal conditions, especially against hypertension (HT). Persistent HT is medically referred to as chronic high blood pressure (BP) and considered to be one of the major risk factors for the deadliest diseases including cardiovascular disease (CVD) and cerebrovascular diseases. Hence HT poses a serious socio-economic burden worldwide, particularly to developing countries. The current treatment strategy for HT includes standard anti-hypertensive drugs, which are associated with many adverse effects and lower drug adherence rates. Therefore, an alternative or complementary natural therapy (functional foods or nutraceuticals or dietary supplements) would be the alternate choice along with a modified lifestyle pattern that might help to manage or combat HT and its related complications. During this review, the author would like to shed light on the basic science behind HT including pathophysiology and the impact of dietary salt on HT and the impact of various functional foods or nutraceuticals against HT in humans (meta-analysis and systemic review). This contribution gives a better idea (public health perspective) for choosing the best functional foods/nutraceuticals for the prevention, management or delaying the onset of HT and its associated conditions along with modified lifestyle patterns and standard anti-hypertensive drugs.

Impact of flaxseed supplementation on plasma lipoprotein(a) concentrations: A systematic review and meta-analysis of randomized controlled trials.

The aim of the study was to investigate the impact of supplementation with flaxseed on plasma lipoprotein(a) [Lp(a)] levels through a systematic review and meta-analysis of eligible randomized placebo-controlled trials. PubMed, Scopus, Cochrane Library, and ISI Web of Science were searched for randomized controlled trials (RCTs) which have been published up to November 2019. RCTs that investigated the effect of flaxseed supplementation on plasma Lp(a) levels in adults were included for final analysis. The random effects model was used for calculating the overall effects. Meta-analysis of 7 selected RCTs with 629 individuals showed significant lowering effect of flaxseed supplementation on Lp(a) (MD -2.06 mg/dl; 95% CI: -3.846, -0.274, p = .024), without considerable heterogeneity between studies (p = .986, I2 = 0%). Subgroup analysis also revealed that longer duration only showed significant lowering effect of flaxseed supplementation on Lp(a). This meta-analysis has shown that flaxseed supplementation might significantly decrease plasma Lp(a) levels. Future well-designed and long-term clinical trials are required to confirm these results.

Effect of fenugreek supplementation on blood lipids and body weight: A systematic review and meta-analysis of randomized controlled trials.

ETHNOPHARMACOLOGICAL RELEVANCE: Fenugreek is a traditional herbal medicine that has been used for centuries to treat hyperglycemia, muscle spasms, gastritis, constipation, edema, and other metabolic disorders. Recently, lipid-lowering effects of fenugreek have been identified. AIM OF THE STUDY: The aim of this systematic review and meta-analysis was to determine and clarify the impact of fenugreek supplementation on anthropometric indices and serum lipid levels. MATERIALS AND METHODS: We searched PubMed, Scopus, ISI Web of Science, Cochrane Library, and Google Scholar from inception to June 2019 using relevant keywords. All randomized controlled trials (RCTs) investigating the effects of fenugreek on anthropometric indices and plasma lipids in adults were included. A random-effects model was used for quantitative data synthesis. A sensitivity analysis was conducted using the leave-one-out method. RESULTS: A meta-analysis of 12 RCTs (14 arms) with 560 participants suggested a significant decrease in plasma concentrations of total cholesterol (WMD = -9.371 mg/dL; 95% CI: -15.419, -3.323, p = 0.002), triglycerides (WMD = -13.776 mg/dL; 95% CI: -26.636, -0.916, p = 0.036), and low density lipoprotein cholesterol (WMD = -6.590 mg/Dl; 95% CI: -13.042, -0.137, p = 0.045), as well as an increase in plasma high density lipoprotein cholesterol (WMD = 3.501 mg/dL; 95% CI: 1.309, 5.692, p = 0.002), while body weight (WMD = 0.223 kg; 95% CI: -0.509, 0.955, p = 0.551) and body mass index (WMD = 0.091 kg/m2; 95% CI: -0.244, 0.426, p = 0.596) were not altered. CONCLUSION: Fenugreek supplementation improved lipid parameters in adults. However, to confirm these results, more studies, particularly among hyperlipidemic patients, are needed.

The ergogenic activity of cider vinegar: A randomized cross-over, double-blind, clinical trial.

This randomized, double-blind, clinical trial was designed to compare the endurance capacity (ergogenic property) in healthy athletes after consumption of apple cider vinegar (ACV) and a commercial sports drink (CSD) before and during endurance exercise. Fourteen healthy participants were enrolled in this trial and were divided into two groups as ACV and CSD with seven participants in each. Participants were requested to consume 500 mL of either commercial ACV or CSD 1 h before endurance exercise (bicycle ergometer). Blood samples were collected at baseline, 0, 20, 40, 60 min until exhaustion to assess glucose, lactate, ammonia and non-esterified fatty acids (NEFA). Respiratory exchange rate (RER) score was measured every 15 min and the heart rate (HR) was measured every 5 min. The outcome of the present trial clearly showed that no significant differences were observed between ACV and CSD except in the blood level of ammonia (only at exhaustion time). Thus, these results show that ACV and the CSD both possessing the ergogenic property, enhanced blood glucose, NEFA, and suppress the production of lactate as well as maintains normal RER score, and HR throughout the endurance exercise. Overall this trial showcases that ACV did not significantly improve the ergogenic activity over the CSD.

Anti-inflammatory properties of fermented pine (Pinus morrisonicola Hay.) needle on lipopolysaccharide-induced inflammation in RAW 264.7 macrophage cells.

This study was aimed to explore the antioxidant and anti-inflammatory activity of various pine needle products (non-fermented, fermented, and commercial) extracted with different solvents (hexane, ethyl acetate, and water) in lipopolysaccharide (LPS) induced RAW 264.7 cells. The phenolic/flavonoid contents of ethyl acetate extract of fermented pine needle (EAE-FPN) is higher than other pine product extracts (hexane/water). The levels of antioxidant indices (TEAC, DPPH) as well as free radical scavenging activity (H2 O2 ) were significantly improved in EAE-FPN than other pine needle product extracts. The levels of ROS and various inflammatory markers (NO, PGE2, TNF-α, and IL-1ß/6) were considerably abolished by EAE-FPN in a dose-dependent manner (50-200 µg/ml). Moreover, the protein expressions of inducible NO synthase (iNOS), cyclooxygenase 2 (COX-2), and nuclear factor Kappa B (NF-κB) p65 subunit were also markedly downregulated by EAE-FPN. Collectively, EAE-FPN with phenolic/flavonoid content showed excellent antioxidant and anti-inflammatory properties via modulating NF-κB signaling pathway. PRACTICAL APPLICATIONS: Pine needle drink (Pinus morrisonicola Hay) has been used as a functional beverage for many years due to its various biological properties in Asia especially in Taiwan, China, and Korea. Many researchers hinted various biological activity of fermented pine needle product but none of them explored the in-depth mechanism underpinning its antioxidant and anti-inflammatory properties in LPS-induced RAW 264.7 cell model. Hence, the current cell line study was designed to assess the underlying mechanism behind the antioxidant and anti-inflammatory activity of Pine needles extract (both non-fermented and fermented) in LPS-induced RAW 264.7 cells (macrophage). The outcome of this study distinctly showed that EAE-FPN displayed potent antioxidant and anti-inflammatory activities by regulating NF-κB signaling pathway. Therefore, pine needle could be developed into functional drink to abolish the progression of inflammatory responses in various disease condition.

Effect of a balanced nutrition meal replacement diet with altered macromolecular composition along with caloric restriction on body weight control.

The prevalence of obesity and its related metabolic syndrome (MetS) has shown an upsurge in recent years due to modified lifestyle patterns. The present study was designed to investigate the impact of a nutritionally balanced conventional meal replacement diet with modified macromolecular composition (rich in soy/pea protein and soluble fibers) and caloric restriction on Taiwanese obese subjects. Obese subjects (BMI > 27; n = 50, male 23, female 27) were recruited and requested to replace two meals per day (breakfast and lunch or dinner) with the balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks with one regular meal and make sure that the daily target calorie limit (caloric restriction) was less than 1500 kcal day-1 for men and 1200 kcal day-1 for women. After eight weeks of intervention with a calorie-restricted balanced partial meal replacement diet, the levels of body weight, body fat, and waist circumference were significantly reduced by 4.1 kg, 2.38%, and 5.06 cm, respectively. The levels of serum total cholesterol (TC), triglycerides (TG) and low-density lipoprotein cholesterol (LDL-c) were significantly decreased (p < 0.05) with a significant increase (p < 0.05) in high-density lipoprotein cholesterol (HDL-c) levels after 8 weeks of intervention with the meal replacement diet. Moreover, the levels of insulin, homeostatic model assessment-insulin resistance (HOMA-IR), leptin, thiobarbituric acid reactive substances (TBARS) and cardiovascular risk factors were significantly attenuated (p < 0.05). To conclude, the present intervention with meal replacement and caloric restriction on obese subjects could concomitantly decrease the body weight and glycemic and cardiovascular risk factors and thereby lower the risk of various metabolic disorders.

Extensive review of popular functional foods and nutraceuticals against obesity and its related complications with a special focus on randomized clinical trials.

Obesity is a multifactorial chronic disease or syndrome mainly caused by an imbalance in energy expenditure and intake. Obesity and its associated complications make it the fifth leading cause of global mortality. The benefits of the current anti-obesity treatment regimen have been marked by high cost and numerous adverse effects. Therefore, many researchers focus on plant-derived/natural products or altered dietary patterns for the management of obesity and its related complications (co-morbidities). Several epidemiological studies have confirmed that the consumption of functional foods/nutraceuticals could considerably lower the risk of various chronic diseases, like obesity, diabetic mellitus, and cancer, but the underpinning mechanism is still unclear. This comprehensive review briefs on the prevalence of obesity, the complications related to obesity, the current treatment regimen and the importance of functional foods and nutraceuticals (molecular mechanism) for the management of body weight and alleviation of its co-morbid conditions. This is the first comprehensive review revealing the in-depth anti-obesity mechanisms of various popular functional foods and nutraceuticals with a special reference to randomized clinical trials (RCTs). Overall, this contribution highlights the importance and beneficial role of functional foods/nutraceuticals on weight management (anti-obesity) and their contributions to the current treatment status, especially related to clinical trials, which could help in the development of novel functional foods/nutraceuticals for combatting obesity and its co-morbidities.

Down-regulation of partial substitution for staple food by oat noodles on blood lipid levels: A randomized, double-blind, clinical trial.

This clinical trial was conducted to assess the lipid-lowering activity of oat noodles by replacing partial staple food (wheat or rice noodle) in normal and mildly hypercholesterolemic subjects. Totally 84 healthy and mild hypercholesterolemic subjects were recruited and divided into 2 groups as experimental (oat noodles) and placebo (wheat noodles) and instructed to consume 100 g of oat noodles or wheat noodles (replacing one or two meals/day) for 10 weeks and followed by 2 weeks of follow up (without noodle consumption). Various anthropometric measurements and biochemical analysis were carried out during initial (baseline), 2nd, 6th, 10th and 12th week (follow-up). Consumption of oat noodles by replacing staple food for 10 weeks significantly reduced (**p < 0.01) the levels of total cholesterol (TC; 17.46%) and low-density lipoprotein LDL-c (19.03%) in both healthy and mildly hypercholesterolemic subjects. However, the hypocholesterolemic effect is significantly higher in mildly hypercholesterolemic subjects as compared with normal subjects. A pronounced decline (*p < 0.05) in the levels of various cardiovascular diseases (CVDs) markers including TC/HDL and LDL/HDL ratios and blood pressure (SBP; 11.09% and DBP; 7.48%) were observed in oat noodles supplemented subjects as equivalence with the placebo group. The partial replacement of staple food with oat noodle could considerably improve the health status of all subjects especially in hypercholesterolemic subjects and thus lower the risk of CVDs.

Beneficial effect of Burdock complex on asymptomatic Helicobacter pylori-infected subjects: A randomized, double-blind placebo-controlled clinical trial.

BACKGROUND: Burdock complex (BC) constitutes of burdock (Arctium lappa), angelica (Angelica sinensis), gromwell (Lithospermum erythrorhizon), and sesame (Sesamum indicum) oil, which are commonly used in traditional Chinese medicine (TCM) for treating various disorders. This study intended to examine the anti-H. pylori activity of BC on AGS cell model as well as in asymptomatic H. pylori-infected subjects. MATERIALS AND METHODS: AGS cell incubated with H. pylori and treated with BC to evaluate the minimum inhibition concentration (MIC), cell viability (MTT) anti-adhesion activity, and inflammatory markers. In case of clinical trial, H. pylori-positive subjects (urea breath test [UBT] >10%, n = 36) were enrolled and requested to intake BC (n = 19) or placebo (n = 17) for 8 weeks. Antioxidant capacity, total phenol, UBT, inflammatory markers were analyzed at the initial, 4th, 8th, and 10th weeks. Moreover, the endoscopic examination was carried out on baseline and 10th week. RESULTS: In vitro studies showed that BC treatment significantly inhibited (P < .05) the inflammatory markers and adhesion of H. pylori to AGS cell. However, H. pylori-infected subject ingested with BC for 8 weeks significantly decreased (P < .05) the UBT value, inflammatory markers with improved antioxidant activity, and phenolic levels as compared to placebo. Also, consumption of BC considerably healed the ulcer wound. CONCLUSION: Overall, the BC could attenuate H. pylori infection by inhibiting H. pylori adhesion and subsequent inflammatory response on the gastric epithelial cell (AGS) as well as clinically ameliorated UBT, antioxidant capacity, and alleviated inflammation to display its anti-H. pylori activity.