Effects of Silybum marianum, Pueraria lobate, combined with Salvia miltiorrhiza tablets on non-alcoholic fatty liver disease in adults: A triple-blind, randomized, placebo-controlled clinical trial.

BACKGROUND & AIMS: Several medicinal plant extracts have demonstrated hepatoprotective effects. However, data are scarce regarding their combined effects on non-alcoholic fatty liver disease (NAFLD). This study aimed to investigate the effects of tablets containing Silybum marianum, Pueraria lobata, and Salvia miltiorrhiza (SPS) on NAFLD progression in Chinese adults. METHODS: In this randomized, triple-blind, placebo-controlled clinical trial, 121 NAFLD patients (60 female and 61 male), diagnosed via magnetic resonance imaging (MRI) and aged 18-65 years, were enrolled. Participants were randomly allocated to receive SPS tablets (n = 60; three tablets per dose, twice daily) or placebo (n = 61) for 24 weeks. Each SPS tablet contained approximately 23.0 mg of silybin, 11.4 mg of puerarin, and 10.9 mg of salvianolic acid. There were no differences in appearance, taste and odour between the SPS tablets and placebo manufactured by BYHEALTH Co., LTD (Guangzhou, China). The primary endpoints were changes in the liver fat content (LFC) and steatosis grade from baseline to 24 weeks. Secondary outcomes included changes in biomarkers/scores of liver fibrosis and steatosis, oxidative stress, inflammatory cytokines, alcohol metabolism, and glucose metabolism. RESULTS: A total of 112 participants completed the research. The intention-to-treat results showed a trend toward reduction in both absolute LFC (-0.52%) and percentage of LFC (-4.57%) in the SPS group compared to the placebo group after 24 weeks, but these changes didn't reach statistical significance (p > 0.05). The SPS intervention (vs. placebo) significantly decreased hypersensitive C-reactive protein level (-6.76%) and increased aldehyde dehydrogenase activity (+18.1%) at 24 weeks post-intervention (all p < 0.05). Per-protocol analysis further supported these effects. This trial is registered at Clinical Trials.gov (NCT05076058). CONCLUSION: SPS supplementation may have potential benefits in improving NAFLD, but further larger-scale trials are necessary to confirm these findings.

Reference Intervals of Serum Iodine Concentration in Chinese Pregnant Women.

The study aims to establish trimester-specific reference ranges for serum iodine (SI) in Chinese pregnant women and explore its associations with maternal and infantile thyroid function. Apparently healthy pregnant women were enrolled during their first antenatal visit. Fasting venous and spot urine samples were collected for determining serum and urinary iodine (UI) levels by a validated inductively coupled plasma mass spectrometry. Serum free triiodothyronine (FT3), free thyroxine (FT4), thyrotropin (TSH), and neonatal TSH levels were tested by electro-chemiluminescent assay. The reference ranges of SI were established by percentile method and reported as 2.5-97.5%. ROC analysis was applied to compare the discriminative ability of SI, UI, and UI to urinary creatine ratio (UI /UCr) in early pregnancy for various thyroid conditions. The trimester-specific reference ranges of SI for Chinese pregnant women were 60.91-114.53 µg/L for the first trimester (T1, n = 1029), 54.57-103.42 µg/L for the second trimester (T2, n = 379), and 52.03-110.40 µg/L for the third trimester (T3, n = 455). Maternal SI at T1 but not UI and UI/UCr was significantly correlated with FT3 (r = 0.393, P < 0.001), FT4 (r = 0.637, P < 0.001), and TSH (r = -0.299, P<0.001). Maternal SI change% from T1 to T2 (but not SI change% from T1 to T3) had marginal correlation with neonatal TSH (r=-0.106, P=0.046). ROC analysis showed that maternal SI at T1 had better predictability for several thyroid conditions than UIC and UI/UCr.

Associations of Maternal Serum Iodine Concentration with Obstetric Complications and Birth Outcomes-Longitudinal Analysis Based on the Huizhou Mother-Infant Cohort, South China.

This study aimed to explore the temporal associations between maternal serum iodine concentration (SIC) and common pregnancy outcomes in Chinese women. Eligible singleton pregnant women aged 20-34 years were selected, and their fasting blood samples were collected during early (T1, n = 1101) and mid-pregnancy (T2, n = 403) for SIC testing by inductively coupled plasma mass spectrometry. Multivariable linear regression indicated that log10SIC at T1 (ß = -0.082), T2 (ß = -0.198), and their % change (ß = -0.131) were inversely associated with gestational weight gain (GWG, all p < 0.05). Maternal log10SIC at both T1 (ß = 0.077) and T2 (ß = 0.105) were positively associated with the Apgar score at 1 min (both p < 0.05). Women in the third quartile (Q3) of SIC at T1 had a lower risk of small for gestational age (SGA, OR = 0.405, 95% CI: 0.198-0.829) compared with those in Q4. Restricted cubic spline regression suggested a U-shaped association between SIC and SGA risk, and SIC above 94 µg/L at T1 was the starting point for an increased risk of SGA. The risk of premature rupture of membrane (PROM) increased by 96% (OR = 1.960, 95% CI: 1.010-3.804) in Q4 compared to that in Q1. Our longitudinal data from an iodine-replete region of China indicated that high maternal SIC could restrict GWG and improve Apgar scores at delivery, but might increase the risk of SGA and PROM.

Effects of plant oils with different fatty acid composition on cardiovascular risk factors in moderately hypercholesteremic Chinese adults: a randomized, double-blinded, parallel-designed trial.

OBJECTIVES: Plant oil for cooking typically provides 40% to 50% of dietary fat, 65% of linoleic acid, 44% of α-linolenic acid and 41% of oleic acid in the Chinese diet. However, the comparative effects of fatty acids derived from plant oil on cardiovascular risk factors in Chinese are still inconclusive. Hence, the aim of this study is to investigate whether cardiovascular risk factors are altered depending on various types of plant oils such as peanut oil rich in oleic acid, corn oil rich in linoleic acid, and blend oil fortified by α-linolenic acid. DESIGN: A randomized, double-blinded, parallel-designed trial. SETTING: The First and the Second Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. PARTICIPANTS: A total of 251 volunteers with fasting blood total cholesterol between 5.13 and 8.00 mmol L-1 were enrolled. INTERVENTION: Volunteers received peanut oil, corn oil or blend oil to use for cooking for one year. MAIN OUTCOME MEASURES: The erythrocyte membrane fatty acid composition, fasting plasma lipids, glucose and insulin concentrations and high sensitivity C-reactive protein (hsCRP) levels were measured before, during and after the intervention. The level of α-linolenic acid in erythrocyte membranes was significantly increased in the blend oil group after the intervention (P < 0.001). The level of other fatty acids did not show any statistically significant differences between the three groups. No significant differences were observed in the concentrations of fasting plasma lipids, hsCRP, glucose, and insulin among the three groups using different types of plant oils. CONCLUSIONS: The results suggest that although ingesting cooking oil with different fatty acid composition for one year could change erythrocyte membrane fatty acid compositions, it did not significantly modify cardiovascular risk factors in moderately hypercholesteremic people.

Glycemic load is associated with diabetes and prediabetes among middle-aged and elderly adults in Guangzhou, China.

BACKGROUND AND OBJECTIVES: Previous studies have obtained conflicting findings regarding the possible associations between glycemic load (GL) indices and diabetes. In the present study, we examined cross-sectional associations between several GL indices, including the total dietary GL, the energy-adjusted GL, and the prevalence of abnormal glucose metabolism, including prediabetes and diabetes. METHODS AND STUDY DESIGN: This study was conducted in Guangzhou, China from July 2011 to December 2011. It included 2,022 participants (602 men and 1,420 women), between 45 and 75 years of age. The prevalence of abnormal glucose metabolism was compared across the quartiles of GL indices to discover any potential linear correlations. Stratified analysis was conducted according to the body mass index (BMI) and waist circumference (WC) measurements. RESULTS: Energy-adjusted GL was positively associated with the prevalence of diabetes and the multivariable-adjusted estimate of the OR comparing the highest versus the lowest quartile was 2.50 (95% CI, 1.49-4.19). For the stratified analysis by sex, BMI or WC, similar associations were observed. For the overweight and obese (BMI ≥24.0 kg/m2) or centrally obese (WC ≥85 cm for men or ≥80 cm for women) participants, compared to participants in the lowest quartile of energy-adjusted GL, those in the highest quartile showed an increased risk of abnormal glucose metabolism. The OR estimates were 2.25 (95% CI: 1.45-3.52) and 1.54 (95% CI: 1.06-2.25), respectively. CONCLUSIONS: High dietary energy-adjusted GL is associated with the prevalence of diabetes as well as abnormal glucose metabolism among middle-aged and elderly adults.

A greater glycemic load reduction was associated with a lower diabetes risk in pre-diabetic patients who consume a high glycemic load diet.

Few prospective studies evaluating the association between dietary glycemic load (GL) and diabetes have accounted for changes in GL. However, the diet of patients could be modified in response to an awareness of pre-diabetes. The aim of this study was to examine the longitudinal associations between changes in GL and the incidence of diabetes among pre-diabetic patients. We hypothesized that subjects with low and high baseline GL would show different correlations with diabetes. A total of 493 pre-diabetic patients (142 men and 351 women) between 40 and 79 years of age were included in this study. Dietary records and oral glucose tolerance tests were conducted every year. The participants were divided into low- and high-GL groups based on baseline GL. During a median 4 years of follow-up, 108 incident cases of diabetes were identified. Among participants with a high baseline GL, the incidence of diabetes increased with decreasing GL reduction, and the multivariate-adjusted HR (95% CI) was 2.34 (1.27-4.29) when comparing the lowest to the highest tertiles; however, among those with a low baseline GL, no significant association was observed. Regardless of baseline GL status, the incidence of diabetes was higher in individuals with a high follow-up GL than in those with a low follow-up GL, and the multivariate-adjusted HR (95% CI) was 1.64 (1.09-2.45). In conclusion, a greater GL reduction was associated with a lower diabetes risk in pre-diabetic patients with a high dietary GL. In patients with pre-diabetes and a low dietary GL, further reductions in GL did not show any additional effects.

Erythrocyte membrane n-3 fatty acid levels and carotid atherosclerosis in Chinese men and women.

OBJECTIVE: Prospective studies have supported the beneficial effects of n-3 fatty acid consumption on cardiac deaths, but limited data focused on atherosclerosis. We investigated the associations between n-3 fatty acids in erythrocytes and atherosclerosis in middle-aged and older Chinese. METHODS: 847 subjects (285 men and 562 women), aged 40-65 years, from Guangzhou, China were included in this community-based cross-sectional study between December 2005 and January 2008. The levels of α-linolenic acid (ALA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in erythrocytes were measured by gas chromatography. Carotid ultrasound examination was conducted to obtain intima-media thickness of the common carotid artery and the carotid bifurcation. Dietary data and other covariates were collected using interviewer-administered questionnaires. RESULTS: After adjustment for age, sex, and other confounders, negative dose-response associations between the contents of individual n-3 polyunsaturated fatty acids in the erythrocyte membrane and the prevalence of carotid artery wall thickening and plaque were observed. A comparison in the highest and lowest tertiles gave odds ratios (95% confidence interval) for thickening in the walls of the common carotid artery of 0.58 (0. 34-0.97; P-trend = 0. 037) for DHA, and 0.39 (0.23-0.67; P-trend < 0.001) for ALA. However, EPA was not significantly associated with carotid atherosclerosis. Similar results were found for thickening at the carotid bifurcation and the occurrence of carotid artery plaque. CONCLUSIONS: Higher levels of DHA and ALA in the erythrocyte membrane were significantly associated with a lower burden of subclinical atherosclerosis.

Association of natural intake of dietary plant sterols with carotid intima-media thickness and blood lipids in Chinese adults: a cross-section study.

BACKGROUND: Many studies showed a moderate cholesterol-lowering effect of plant sterols (PS), but increased circulating PS might be atherogenic. We evaluated the associations between natural dietary intake of PS and carotid intima-media thickness (IMT) and serum lipids. METHODOLOGY/PRINCIPAL FINDINGS: This community-based cross-sectional study included 1160 men and 2780 women aged 31-75 years. Dietary intakes were assessed using a food-frequency questionnaire. The IMTs at the common, bifurcation and internal carotid artery segments, and fasting serum total (TC), LDL (LDLc) and HDL (HDLc) cholesterol, and triglycerides (TG) were determined. After adjusting for potential covariates, multivariate analysis showed a dose-dependent inverse association of total PS intake with serum TC, LDLc, non-HDLc in women (P<0.001) and in men (P<0.05). As compared to the lowest quartile of PS intake (<206 mg/d), the multivariate-adjusted means of TC, LDLc and non-HDLc in the highest quartile of PS intake (447 mg/d) decreased by 5.0%, 6.2% and 6.5% in women (P<0.005), and by 6.4%, 7.1% and 6.7% (P>0.05) in men. Although the IMTs tended to be lower with greater intake of dietary PS, only small differences in the left internal IMT between the highest and lowest groups were observed among men (-7.6%) and women (-5.1%) (P<0.05). The multivariate analysis showed no significant mean differences among the PS groups in HDLc, TG and IMTs at other studied sites among men and women (all P>0.05). CONCLUSIONS: Greater PS consumption from natural diets is associated with lower serum total, LDL, non-HDL cholesterol and with thinner left internal IMT in women and men.

Association of interleukin-6 gene -572 C > G polymorphism with dietary intake of n-3 fatty acids on plasma HDL-c level in Chinese male adults.

OBJECTIVE: Heterogeneity in circulating lipid concentrations in response to different dietary fat intakes may be due, in part, to gene polymorphism of cytokine related to inflammation. The objective was to determine whether dietary n-3 PUFAs intake influenced the effects of IL-6 -572 polymorphism on plasma lipids and apolipoproteins. STUDY DESIGN: This cross-sectional study included 195 men and 386 women aged 40-65 y. DNA was isolated from white blood cell to determine the IL-6 -572 C-G polymorphisms by the polymerase chain reaction-logation detection reaction (PCR-LDR) method. Dietary fatty acids were assessed by measuring erythrocyte membrane fatty acids, and fasting plasma was collected to determine blood lipids and apoproteins. RESULTS: The frequency of the G allele was 0.214. There were no significant differences in plasma lipids across genotypes (all p > 0.05). When men and women were grouped into tertiles by the erythrocyte membrane n-3 PUFAs composition; in the lowest group, men with G allele had 18% higher HDL-cholesterol concentrations than did C/C genotype (p < 0.05). Similar effects were observed for apo A. Adjusting for age, BMI and total PUFA did not alter this association. The interaction was not significant in women. CONCLUSION: Dietary n-3 PUFA intake influenced the effects of IL-6 -572 genotype on HDL-c concentrations in males.

Validation of an FFQ to estimate the intake of fatty acids using erythrocyte membrane fatty acids and multiple 3d dietary records.

OBJECTIVE: The estimation of dietary intake in population-based studies is often assessed by the FFQ. The objective of our study is to evaluate the validity of an FFQ used to assess dietary fatty acid intake among middle-aged Chinese adults in Southern China. DESIGN: The method of triads was applied to obtain the validity coefficients (VC) of the FFQ for specific fatty acids. A subsample was randomly selected from an earlier cross-sectional study. The FFQ and 3d dietary records were used for dietary assessment, and the fatty acid composition of erythrocyte membranes was determined as the biomarker. RESULTS: The Spearman correlation coefficients between the FFQ and 3d dietary records were moderate to good (r = 0.28-0.66). The VC of the FFQ estimated by the method of triads were 0.72, 0.61, 0.65, 0.75 and 0.67 for MUFA, total n-6 fatty acids, alpha-linolenic acid, EPA and DHA, respectively. The VC could not be calculated for SFA, PUFA and total n-3 fatty acids because of negative correlations among the three measurements. But, the correlations between the FFQ and the dietary records were moderate for these fatty acids. CONCLUSIONS: Our FFQ applied in Southern Chinese adults was valid to estimate their dietary fatty acid intake and was thus suitable for use in a large cohort study.

[Relationship between dietary soy isoflavones and blood lipid levels in 40 - 65 year-olds in Guangzhou].

OBJECTIVE: To study the relationship between dietary soy isoflavones and blood lipids among residents of 40 - 65 years old, in Guangzhou. METHODS: Dietary soy isoflavones and other nutrients intakes were assessed with quantitative food frequency questionnaire (FFQ). Total cholesterol (TC), triglycerides (TG), HDL cholesterol (HDL-C) and LDL cholesterol (LDL-C) in plasma were measured with colorimetry. RESULTS: Ranges of dietary soy isoflavones intake among 134 males and 261 females were from 0 mg/day to 61.96 mg/day and 0 mg/day to 82.52 mg/day, with means of 11.95 mg/day, 14.90 mg/day, respectively. After adjusted for total energy intake and fat percent energy, differences of TC, LDL-C in total population and TC in women were statistically significant between groups (P value was 0.002, 0.008, 0.004, respectively) and dose-effect relationships (P value was < 0.001, 0.012, 0.001, respectively) were observed between dietary soy isoflavones intake and the upper mentioned three indices. Compared with the low-intake group, these three indices lowered 7.06%, 10.13% and 7.48%, respectively in high-intake group. Critical significance of LDL-C was observed both in women and men between groups. Further controlled for age, BMI and WHR, no obvious change of the results was observed. CONCLUSION: Moderate intakes of soy isoflavone as part of a regular diet seemed to be associated with favorable blood lipid levels.

Greater habitual soyfood consumption is associated with decreased carotid intima-media thickness and better plasma lipids in Chinese middle-aged adults.

Many clinical studies have shown high-dose supplemental soy protein has beneficial effects on cardiovascular risk factors. We examined the association between habitual soyfood intake and carotid intima-media thickness (IMT) and plasma lipids in a cross-sectional study including 406 (M 134, F 272) middle-aged Chinese adults (40-65 years) without confirmed relevant diseases. We found significantly dose-respondent decreases in bifurcation IMT, total and LDL cholesterol associated with increased usual soyfood intake after adjusting for potential confounders (p for trend, all p<0.05). Covariate-adjusted mean bifurcation IMT, total and LDL cholesterol decreased by 9.4%, 6.2% and 10.4% in women (p=0.020, 0.035, 0.110), 16.0%, 12.3% and 19.6% in men (p=0.036, 0.005, 0.002), and 9.9%, 9.3% and 15.4% in total men and women combined (p=0.010, <0.001, <0.001) when the mean intake of soy protein increased from 0.87 (F) or 0.64 (M) g/day (1st tertile) to 8.35 (F) or 7.48 (M) g/day (3rd tertile), respectively. Significant interaction between sex and soy consumption on bifurcation IMT was observed (p=0.008). In conclusion, higher habitual soyfood consumption is associated with decreased bifurcation IMT, plasma TC and LDL-c in middle-aged Chinese adults. The association is more apparent in men than in women.

Effects of dietary medium-chain triglyceride on weight loss and insulin sensitivity in a group of moderately overweight free-living type 2 diabetic Chinese subjects.

Prior studies of medium-chain triglyceride (MCT) suggest that MCT might be a useful tool for body fat mass management in obese nondiabetic humans. We now report a pilot study that tests if MCT is beneficial for moderately overweight subjects with type 2 diabetes mellitus. The study was conducted in a group of 40 free-living subjects in an urban area of China. The subjects were randomized into 2 test groups, with one given MCT and the other corn oil as control for long-chain triglycerides (LCTs). The test oil (18 g/d) was administered as part of daily food intake for 90 days. All subjects completed the study with self-reported full compliance. Body weight, waist circumference (WC), and serum samples were analyzed on days 0, 45, and 90. The MCT group showed an across-time reduction in body weight and WC, an increase in serum C-peptide concentration, a reduction in homeostasis model assessment of insulin resistance, and a decrease in serum cholesterol concentration (P < .05, repeated measures). No significant across-time difference for the above parameters was detected for the LCT group. These changes were associated with an involuntary reduction in energy intake in the MCT group (P < .05, repeated measures). A between-group comparison also shows reduced body weight, WC, and homeostasis model assessment of insulin resistance in the MCT group compared with the LCT group at the end of the study. Collectively, our results suggest a link between moderate consumption of MCT and improved risk factors in moderately overweight humans in a low-cost, free-living setting.