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1.
Appl Physiol Nutr Metab ; 45(3): 340-343, 2020 Mar.
Article in English | MEDLINE | ID: mdl-31751150

ABSTRACT

This study compared the weight loss efficacy of alternate-day fasting (ADF) versus daily calorie restriction (CR) in adults with subclinical hypothyroidism. After 6 months, body weight decreased (P < 0.001) similarly by ADF (-7% ± 1%) and CR (-8% ± 2%). Insulin resistance decreased (P < 0.05) more by ADF versus CR. Free thyroxin and thyroid-stimulating hormone remained unchanged. Thus, ADF and CR produce similar weight loss in this population, without affecting thyroid hormone levels. Novelty Intermittent fasting and daily restriction produce similar reductions in body weight in subjects with subclinical hypothyroidism.


Subject(s)
Caloric Restriction/methods , Fasting/physiology , Hypothyroidism/complications , Obesity/complications , Obesity/diet therapy , Weight Loss/physiology , Adolescent , Adult , Aged , Diet, Reducing/methods , Female , Follow-Up Studies , Humans , Male , Middle Aged , Young Adult
2.
Obesity (Silver Spring) ; 27(9): 1443-1450, 2019 09.
Article in English | MEDLINE | ID: mdl-31328895

ABSTRACT

OBJECTIVE: This study compared the effects of alternate-day fasting (ADF) with those of daily calorie restriction (CR) on body weight and glucoregulatory factors in adults with overweight or obesity and insulin resistance. METHODS: This secondary analysis examined the data of insulin-resistant individuals (n = 43) who participated in a 12-month study that compared ADF (25% energy needs on "fast days"; 125% energy needs on alternating "feast days") with CR (75% energy needs every day) and a control group regimen. RESULTS: In insulin-resistant participants, weight loss was not different between ADF (-8% ± 2%) and CR (-6% ± 1%) by month 12, relative to controls (P < 0.0001). Fat mass and BMI decreased (P < 0.05) similarly from ADF and CR. ADF produced greater decreases (P < 0.05) in fasting insulin (-52% ± 9%) and insulin resistance (-53% ± 9%) compared with CR (-14% ± 9%; -17% ± 11%) and the control regimen by month 12. Lean mass, visceral fat mass, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, blood pressure, C-reactive protein, tumor necrosis factor α, and interleukin 6 values remained unchanged. CONCLUSIONS: These findings suggest that ADF may produce greater reductions in fasting insulin and insulin resistance compared with CR in insulin-resistant participants despite similar decreases in body weight.


Subject(s)
Caloric Restriction/methods , Fasting/physiology , Insulin Resistance/physiology , Insulin/blood , Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged , Young Adult
3.
Nutr Health ; 25(3): 167-171, 2019 Sep.
Article in English | MEDLINE | ID: mdl-30983506

ABSTRACT

BACKGROUND: Alternate-day fasting (ADF) involves a 'famine day' (25% energy intake) and a 'feast day' (ad libitum intake). This secondary analysis examined changes in beverage intake in relation to energy intake and body weight during 12 months of ADF versus daily calorie restriction (CR). METHODS: Obese subjects (n = 100 enrolled, n = 69 completers) were randomized to one of three groups for 12 months: (a) ADF; (b) CR; or (c) control. RESULTS: At baseline, intakes of diet soda, caffeinated beverages, sugar-sweetened soda, alcohol, juice, and milk were similar between groups. There were no statistically significant changes in the intake of these beverages by month 6 or 12 between ADF (feast or famine day), CR, or control groups. Beverage intake was not related to energy intake or body weight at month 6 or 12 in any group. CONCLUSION: These pilot findings suggest that intermittent fasting does not impact beverage intake in a way that affects energy intake or body weight.


Subject(s)
Beverages/statistics & numerical data , Body Weight/physiology , Energy Intake/physiology , Fasting/physiology , Obesity/diet therapy , Adolescent , Adult , Aged , Alcoholic Beverages/statistics & numerical data , Animals , Caloric Restriction/methods , Carbonated Beverages/statistics & numerical data , Female , Follow-Up Studies , Fruit and Vegetable Juices/statistics & numerical data , Humans , Male , Middle Aged , Milk/statistics & numerical data , Pilot Projects , Sugar-Sweetened Beverages/statistics & numerical data , Young Adult
4.
JAMA ; 320(1): 94-95, 2018 07 03.
Article in English | MEDLINE | ID: mdl-29971394
5.
Adv Nutr ; 9(4): 367-377, 2018 07 01.
Article in English | MEDLINE | ID: mdl-30032218

ABSTRACT

A large majority of human nutrition research uses nonrandomized observational designs, but this has led to little reliable progress. This is mostly due to many epistemologic problems, the most important of which are as follows: difficulty detecting small (or even tiny) effect sizes reliably for nutritional risk factors and nutrition-related interventions; difficulty properly accounting for massive confounding among many nutrients, clinical outcomes, and other variables; difficulty measuring diet accurately; and suboptimal research reporting. Tiny effect sizes and massive confounding are largely unfixable problems that narrowly confine the scenarios in which nonrandomized observational research is useful. Although nonrandomized studies and randomized trials have different priorities (assessment of long-term causality compared with assessment of treatment effects), the odds for obtaining reliable information with the former are limited. Randomized study designs should therefore largely replace nonrandomized studies in human nutrition research going forward. To achieve this, many of the limitations that have traditionally plagued most randomized trials in nutrition, such as small sample size, short length of follow-up, high cost, and selective reporting, among others, must be overcome. Pivotal megatrials with tens of thousands of participants and lifelong follow-up are possible in nutrition science with proper streamlining of operational costs. Fixable problems that have undermined observational research, such as dietary measurement error and selective reporting, need to be addressed in randomized trials. For focused questions in which dietary adherence is important to maximize, trials with direct observation of participants in experimental in-house settings may offer clean answers on short-term metabolic outcomes. Other study designs of randomized trials to consider in nutrition include registry-based designs and "N-of-1" designs. Mendelian randomization designs may also offer some more reliable leads for testing interventions in trials. Collectively, an improved randomized agenda may clarify many things in nutrition science that might never be answered credibly with nonrandomized observational designs.


Subject(s)
Nutrition Therapy , Nutritional Physiological Phenomena , Observational Studies as Topic , Randomized Controlled Trials as Topic , Research Design , Bias , Diet , Diet Records , Humans , Meta-Analysis as Topic , Registries
6.
Nutr Healthy Aging ; 4(4): 345-353, 2018 Jun 15.
Article in English | MEDLINE | ID: mdl-29951594

ABSTRACT

BACKGROUND: Time restricted feeding decreases energy intake without calorie counting and may be a viable option for weight loss. However, the effect of this diet on body weight in obese subjects has never been examined. OBJECTIVE: This study investigated the effects of 8-h time restricted feeding on body weight and metabolic disease risk factors in obese adults. DESIGN: Obese subjects (n = 23) participated in an 8-h time restricted feeding intervention (ad libitum feeding between 10:00 to 18:00 h, water fasting between 18:00 to 10:00 h) for 12 weeks. Weight loss and other outcomes were compared to a matched historical control group (n = 23). RESULTS: Body weight and energy intake decreased in the time restricted group (-2.6% ± 0.5; -341 ± 53 kcal/d) relative to controls over 12 weeks (P < 0.05). Systolic blood pressure decreased in the time restricted feeding group (-7 ± 2 mm Hg) versus controls (P < 0.05). Fat mass, lean mass, visceral fat mass, diastolic blood pressure, LDL cholesterol, HDL cholesterol, triglycerides, fasting glucose, fasting insulin, HOMA-IR, and homocysteine were not significantly different from controls after 12 weeks (no group×time interaction). CONCLUSION: These findings suggest that 8-h time restricted feeding produces mild caloric restriction and weight loss, without calorie counting. It may also offer clinical benefits by reducing blood pressure.

7.
JAMA ; 319(7): 667-679, 2018 02 20.
Article in English | MEDLINE | ID: mdl-29466592

ABSTRACT

Importance: Dietary modification remains key to successful weight loss. Yet, no one dietary strategy is consistently superior to others for the general population. Previous research suggests genotype or insulin-glucose dynamics may modify the effects of diets. Objective: To determine the effect of a healthy low-fat (HLF) diet vs a healthy low-carbohydrate (HLC) diet on weight change and if genotype pattern or insulin secretion are related to the dietary effects on weight loss. Design, Setting, and Participants: The Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) randomized clinical trial included 609 adults aged 18 to 50 years without diabetes with a body mass index between 28 and 40. The trial enrollment was from January 29, 2013, through April 14, 2015; the date of final follow-up was May 16, 2016. Participants were randomized to the 12-month HLF or HLC diet. The study also tested whether 3 single-nucleotide polymorphism multilocus genotype responsiveness patterns or insulin secretion (INS-30; blood concentration of insulin 30 minutes after a glucose challenge) were associated with weight loss. Interventions: Health educators delivered the behavior modification intervention to HLF (n = 305) and HLC (n = 304) participants via 22 diet-specific small group sessions administered over 12 months. The sessions focused on ways to achieve the lowest fat or carbohydrate intake that could be maintained long-term and emphasized diet quality. Main Outcomes and Measures: Primary outcome was 12-month weight change and determination of whether there were significant interactions among diet type and genotype pattern, diet and insulin secretion, and diet and weight loss. Results: Among 609 participants randomized (mean age, 40 [SD, 7] years; 57% women; mean body mass index, 33 [SD, 3]; 244 [40%] had a low-fat genotype; 180 [30%] had a low-carbohydrate genotype; mean baseline INS-30, 93 µIU/mL), 481 (79%) completed the trial. In the HLF vs HLC diets, respectively, the mean 12-month macronutrient distributions were 48% vs 30% for carbohydrates, 29% vs 45% for fat, and 21% vs 23% for protein. Weight change at 12 months was -5.3 kg for the HLF diet vs -6.0 kg for the HLC diet (mean between-group difference, 0.7 kg [95% CI, -0.2 to 1.6 kg]). There was no significant diet-genotype pattern interaction (P = .20) or diet-insulin secretion (INS-30) interaction (P = .47) with 12-month weight loss. There were 18 adverse events or serious adverse events that were evenly distributed across the 2 diet groups. Conclusions and Relevance: In this 12-month weight loss diet study, there was no significant difference in weight change between a healthy low-fat diet vs a healthy low-carbohydrate diet, and neither genotype pattern nor baseline insulin secretion was associated with the dietary effects on weight loss. In the context of these 2 common weight loss diet approaches, neither of the 2 hypothesized predisposing factors was helpful in identifying which diet was better for whom. Trial Registration: clinicaltrials.gov Identifier: NCT01826591.


Subject(s)
Diet, Carbohydrate-Restricted , Diet, Fat-Restricted , Diet, Reducing , Insulin/blood , Obesity/diet therapy , Adult , Energy Intake , Female , Genotype , Humans , Insulin Resistance , Male , Middle Aged , Obesity/genetics , Overweight/diet therapy , Overweight/genetics , Weight Loss , Young Adult
8.
Nutr Health ; 24(1): 5-10, 2018 Mar.
Article in English | MEDLINE | ID: mdl-29353535

ABSTRACT

BACKGROUND: Alternate-day fasting (ADF) has gained popularity in recent years. The diet consists of a "fast day" where an individual consumes 0-25% of their energy needs, alternated with a "feast day" where a person is permitted to eat ad libitum. AIM: This study examined eating behavior traits of successful weight losers during alternate day fasting. METHODS: Obese participants ( n = 34) took part in 12 months of ADF and were grouped into a high (≥5%) or low-weight-loss (<5%) group post-treatment. RESULTS: The high-weight-loss group demonstrated increased ( p = 0.04) fullness, decreased ( p = 0.03) hunger, increased dietary protein intake (15% to 20% of kcal, p = 0.04), and better adherence to fast-day calorie goals. CONCLUSIONS: Thus, individuals who achieve clinically significant weight loss with ADF demonstrate improved satiety, increased protein intake, and better adherence to fast-day calorie goals.


Subject(s)
Diet, Reducing , Dietary Proteins/administration & dosage , Fasting , Feeding Behavior , Obesity/diet therapy , Patient Compliance , Satiety Response , Actigraphy , Adult , Body Mass Index , Caloric Restriction , Chicago , Energy Intake , Exercise , Female , Humans , Male , Middle Aged , Self Efficacy , Self Report , Self-Control , Weight Loss
9.
Clin Nutr ; 37(6 Pt A): 1871-1878, 2018 12.
Article in English | MEDLINE | ID: mdl-29258678

ABSTRACT

BACKGROUND & AIMS: Indirect comparisons suggest that alternate-day fasting (ADF) may produce greater improvements in body composition, fat distribution, and/or the adipokine profile compared to daily calorie restriction (CR), but this has not been tested directly. In a pre-planned secondary analysis of a randomized controlled trial, we compared changes in the VAT:SAT ratio, FFM:total mass ratio, and the adipokine profile between ADF and CR. METHODS: Overweight and obese participants (n = 100) were randomized to 1) ADF (alternating every 24-h between consuming 25% or 125% of energy needs); 2) CR (consuming 75% of needs every day); or 3) control (consuming 100% of needs every day) for 24 wk. RESULTS: The VAT:SAT ratio did not change in any group. The FFM:total mass ratio increased in both ADF (0.03 ± 0.00) and CR (0.03 ± 0.01) compared to the control group (P < 0.01), with no differences between the intervention groups. Circulating leptin decreased in both the ADF group (-18 ± 6%) and CR group (-31 ± 10%) relative to the control group (P < 0.05), with no differences between the intervention groups. Circulating levels of adiponectin, resistin, IL-6, and TNF-α did not change in either intervention group relative to the control group. CONCLUSION: ADF and CR similarly improve the FFM:total mass ratio and reduce leptin after a 24-wk intervention. TRIAL REGISTRATION: Clinicaltrials.gov, number NCT00960505.


Subject(s)
Adipokines/blood , Body Composition/physiology , Caloric Restriction , Diet, Reducing/methods , Fasting , Adult , Body Weight , Exercise , Female , Humans , Leptin/blood , Male , Middle Aged , Obesity/diet therapy , Overweight/diet therapy , Treatment Outcome , Weight Loss
11.
Nutr Healthy Aging ; 4(3): 255-263, 2017 Dec 07.
Article in English | MEDLINE | ID: mdl-29276795

ABSTRACT

BACKGROUND: Alternate day fasting (ADF) is a novel diet therapy that reduces body weight, but its effect on bone health remains unknown. OBJECTIVE: This study examined the impact of ADF versus traditional daily calorie restriction (CR) on markers of bone metabolism in a 6-month randomized controlled trial. METHODS: Overweight and obese subjects (n = 100) were randomized to 1 of 3 groups for 6 months: 1) ADF (25% energy intake fast day, alternated with 125% intake feast day; 2) CR (75% intake every day); or 3) control (usual intake every day). RESULTS: Body weight decreased similarly (P < 0.001) by ADF (-7.8±1.2%) and CR (-8.8±1.5%), relative to controls by month 6. Lean mass, total body bone mineral content and total body bone mineral density remained unchanged in all groups. Circulating osteocalcin, bone alkaline phosphatase, and C-terminal telopeptide type I collagen (CTX) did not change in any group. IGF-1 increased (P < 0.01) in the CR group, with no change in the ADF or control group. When the data were sub-analyzed according to menopausal status, there were no differences between premenopausal or postmenopausal women for any marker of bone metabolism. CONCLUSION: These findings suggest that 6 months of ADF does not have any deleterious impact on markers of bone metabolism in obese adults with moderate weight loss.

13.
JAMA Intern Med ; 177(7): 930-938, 2017 07 01.
Article in English | MEDLINE | ID: mdl-28459931

ABSTRACT

Importance: Alternate-day fasting has become increasingly popular, yet, to date, no long-term randomized clinical trials have evaluated its efficacy. Objective: To compare the effects of alternate-day fasting vs daily calorie restriction on weight loss, weight maintenance, and risk indicators for cardiovascular disease. Design, Setting, and Participants: A single-center randomized clinical trial of obese adults (18 to 64 years of age; mean body mass index, 34) was conducted between October 1, 2011, and January 15, 2015, at an academic institution in Chicago, Illinois. Interventions: Participants were randomized to 1 of 3 groups for 1 year: alternate-day fasting (25% of energy needs on fast days; 125% of energy needs on alternating "feast days"), calorie restriction (75% of energy needs every day), or a no-intervention control. The trial involved a 6-month weight-loss phase followed by a 6-month weight-maintenance phase. Main Outcomes and Measures: The primary outcome was change in body weight. Secondary outcomes were adherence to the dietary intervention and risk indicators for cardiovascular disease. Results: Among the 100 participants (86 women and 14 men; mean [SD] age, 44 [11] years), the dropout rate was highest in the alternate-day fasting group (13 of 34 [38%]), vs the daily calorie restriction group (10 of 35 [29%]) and control group (8 of 31 [26%]). Mean weight loss was similar for participants in the alternate-day fasting group and those in the daily calorie restriction group at month 6 (-6.8% [95% CI, -9.1% to -4.5%] vs -6.8% [95% CI, -9.1% to -4.6%]) and month 12 (-6.0% [95% CI, -8.5% to -3.6%] vs -5.3% [95% CI, -7.6% to -3.0%]) relative to those in the control group. Participants in the alternate-day fasting group ate more than prescribed on fast days, and less than prescribed on feast days, while those in the daily calorie restriction group generally met their prescribed energy goals. There were no significant differences between the intervention groups in blood pressure, heart rate, triglycerides, fasting glucose, fasting insulin, insulin resistance, C-reactive protein, or homocysteine concentrations at month 6 or 12. Mean high-density lipoprotein cholesterol levels at month 6 significantly increased among the participants in the alternate-day fasting group (6.2 mg/dL [95% CI, 0.1-12.4 mg/dL]), but not at month 12 (1.0 mg/dL [95% CI, -5.9 to 7.8 mg/dL]), relative to those in the daily calorie restriction group. Mean low-density lipoprotein cholesterol levels were significantly elevated by month 12 among the participants in the alternate-day fasting group (11.5 mg/dL [95% CI, 1.9-21.1 mg/dL]) compared with those in the daily calorie restriction group. Conclusions and Relevance: Alternate-day fasting did not produce superior adherence, weight loss, weight maintenance, or cardioprotection vs daily calorie restriction. Trial Registration: clinicaltrials.gov Identifier: NCT00960505.


Subject(s)
Caloric Restriction/methods , Cardiovascular Diseases/prevention & control , Fasting , Obesity , Adult , Blood Glucose/analysis , Blood Glucose/metabolism , Cardiovascular Diseases/metabolism , Diet Therapy/methods , Fasting/physiology , Fasting/psychology , Feeding Behavior/physiology , Female , Humans , Insulin/analysis , Insulin/blood , Male , Middle Aged , Obesity/diagnosis , Obesity/diet therapy , Obesity/metabolism , Obesity/psychology , Outcome and Process Assessment, Health Care , Patient Compliance , Risk Factors , Weight Loss
14.
JAMA Intern Med ; 177(4): 554-560, 2017 04 01.
Article in English | MEDLINE | ID: mdl-28192563

ABSTRACT

Importance: Many published randomized clinical trials (RCTs) make claims for subgroup differences. Objective: To evaluate how often subgroup claims reported in the abstracts of RCTs are actually supported by statistical evidence (P < .05 from an interaction test) and corroborated by subsequent RCTs and meta-analyses. Data Sources: This meta-epidemiological survey examines data sets of trials with at least 1 subgroup claim, including Subgroup Analysis of Trials Is Rarely Easy (SATIRE) articles and Discontinuation of Randomized Trials (DISCO) articles. We used Scopus (updated July 2016) to search for English-language articles citing each of the eligible index articles with at least 1 subgroup finding in the abstract. Study Selection: Articles with a subgroup claim in the abstract with or without evidence of statistical heterogeneity (P < .05 from an interaction test) in the text and articles attempting to corroborate the subgroup findings. Data Extraction and Synthesis: Study characteristics of trials with at least 1 subgroup claim in the abstract were recorded. Two reviewers extracted the data necessary to calculate subgroup-level effect sizes, standard errors, and the P values for interaction. For individual RCTs and meta-analyses that attempted to corroborate the subgroup findings from the index articles, trial characteristics were extracted. Cochran Q test was used to reevaluate heterogeneity with the data from all available trials. Main Outcomes and Measures: The number of subgroup claims in the abstracts of RCTs, the number of subgroup claims in the abstracts of RCTs with statistical support (subgroup findings), and the number of subgroup findings corroborated by subsequent RCTs and meta-analyses. Results: Sixty-four eligible RCTs made a total of 117 subgroup claims in their abstracts. Of these 117 claims, only 46 (39.3%) in 33 articles had evidence of statistically significant heterogeneity from a test for interaction. In addition, out of these 46 subgroup findings, only 16 (34.8%) ensured balance between randomization groups within the subgroups (eg, through stratified randomization), 13 (28.3%) entailed a prespecified subgroup analysis, and 1 (2.2%) was adjusted for multiple testing. Only 5 (10.9%) of the 46 subgroup findings had at least 1 subsequent pure corroboration attempt by a meta-analysis or an RCT. In all 5 cases, the corroboration attempts found no evidence of a statistically significant subgroup effect. In addition, all effect sizes from meta-analyses were attenuated toward the null. Conclusions and Relevance: A minority of subgroup claims made in the abstracts of RCTs are supported by their own data (ie, a significant interaction effect). For those that have statistical support (P < .05 from an interaction test), most fail to meet other best practices for subgroup tests, including prespecification, stratified randomization, and adjustment for multiple testing. Attempts to corroborate statistically significant subgroup differences are rare; when done, the initially observed subgroup differences are not reproduced.


Subject(s)
Evidence-Based Medicine , Publishing/standards , Randomized Controlled Trials as Topic , Data Interpretation, Statistical , Diagnosis-Related Groups , Evidence-Based Medicine/methods , Evidence-Based Medicine/standards , Humans , Intention to Treat Analysis , Randomized Controlled Trials as Topic/methods , Randomized Controlled Trials as Topic/standards
15.
Contemp Clin Trials ; 53: 151-161, 2017 02.
Article in English | MEDLINE | ID: mdl-28027950

ABSTRACT

Numerous studies have attempted to identify successful dietary strategies for weight loss, and many have focused on Low-Fat vs. Low-Carbohydrate comparisons. Despite relatively small between-group differences in weight loss found in most previous studies, researchers have consistently observed relatively large between-subject differences in weight loss within any given diet group (e.g., ~25kg weight loss to ~5kg weight gain). The primary objective of this study was to identify predisposing individual factors at baseline that help explain differential weight loss achieved by individuals assigned to the same diet, particularly a pre-determined multi-locus genotype pattern and insulin resistance status. Secondary objectives included discovery strategies for further identifying potential genetic risk scores. Exploratory objectives included investigation of an extensive set of physiological, psychosocial, dietary, and behavioral variables as moderating and/or mediating variables and/or secondary outcomes. The target population was generally healthy, free-living adults with BMI 28-40kg/m2 (n=600). The intervention consisted of a 12-month protocol of 22 one-hour evening instructional sessions led by registered dietitians, with ~15-20 participants/class. Key objectives of dietary instruction included focusing on maximizing the dietary quality of both Low-Fat and Low-Carbohydrate diets (i.e., Healthy Low-Fat vs. Healthy Low-Carbohydrate), and maximally differentiating the two diets from one another. Rather than seeking to determine if one dietary approach was better than the other for the general population, this study sought to examine whether greater overall weight loss success could be achieved by matching different people to different diets. Here we present the design and methods of the study.


Subject(s)
Diet, Carbohydrate-Restricted , Diet, Fat-Restricted , Diet, Reducing , Genotype , Insulin Resistance , Obesity/diet therapy , Adult , Body Composition , Energy Metabolism , Exercise , Female , Humans , Male , Middle Aged , Proteomics , Single-Blind Method , Treatment Outcome , Young Adult
16.
BMJ ; 355: i5826, 2016 Nov 24.
Article in English | MEDLINE | ID: mdl-27884869

ABSTRACT

OBJECTIVE:  To evaluate the frequency, validity, and relevance of statistically significant (P<0.05) sex-treatment interactions in randomized controlled trials in Cochrane meta-analyses. DESIGN:  Meta-epidemiological study. DATA SOURCES:  Cochrane Database of Systematic Reviews (CDSR) and PubMed. ELIGIBILITY CRITERIA FOR STUDY SELECTION:  Reviews published in the CDSR with sex-treatment subgroup analyses in the forest plots, using data from randomized controlled trials. DATA EXTRACTION:  Information on the study design and sex subgroup data were extracted from reviews and forest plots that met inclusion criteria. For each statistically significant sex-treatment interaction, the potential for biological plausibility and clinical significance was considered. RESULTS:  Among the 41 reviews with relevant data, there were 109 separate treatment-outcome analyses ("topics"). Among the 109 topics, eight (7%) had a statistically significant sex-treatment interaction. The 109 topics included 311 randomized controlled trials (162 with both sexes, 46 with males only, 103 with females only). Of the 162 individual randomized controlled trials that included both sexes, 15 (9%) had a statistically significant sex-treatment interaction. Of four topics where the first published randomized controlled trial had a statistically significant sex-treatment interaction, no meta-analyses that included other randomized controlled trials retained the statistical significance and no meta-analyses showed statistical significance when data from the first published randomized controlled trial were excluded. Of the eight statistically significant sex-treatment interactions from the overall analyses, only three were discussed by the CDSR reviewers for a potential impact on different clinical management for males compared with females. None of these topics had a sex-treatment interaction that influenced treatment recommendations in recent guidelines. UpToDate, an online physician-authored clinical decision support resource, suggested differential management of men and women for one of these sex-treatment interactions. CONCLUSION:  Statistically significant sex-treatment interactions are only slightly more frequent than what would be expected by chance and there is little evidence of subsequent corroboration or clinical relevance of sex-treatment interactions.


Subject(s)
Randomized Controlled Trials as Topic/statistics & numerical data , Benzodiazepines/adverse effects , Benzodiazepines/therapeutic use , Bias , Carotid Stenosis/epidemiology , Carotid Stenosis/therapy , Endarterectomy, Carotid/statistics & numerical data , Female , Humans , Hyperprolactinemia/chemically induced , Hyperprolactinemia/epidemiology , Incidence , Lung Neoplasms/epidemiology , Lung Neoplasms/therapy , Male , Olanzapine , Outcome Assessment, Health Care/statistics & numerical data , Prolactin/blood , Risperidone/adverse effects , Risperidone/therapeutic use , Sex Factors , Stroke/epidemiology , Stroke/prevention & control
17.
Clin Nutr ; 35(6): 1380-1385, 2016 12.
Article in English | MEDLINE | ID: mdl-27062219

ABSTRACT

BACKGROUND & AIMS: Alternate day fasting (ADF; 25% energy intake "fast day", alternated with an ad libitum intake "feed day") is effective for weight loss. Whether or not ADF modulates hunger, fullness and gut peptides in a way that enhances dietary compliance and weight loss, remains unknown. Accordingly, this study examined the effect of ADF on postprandial appetite ratings and gut peptides. METHODS: Obese subjects (n = 59) participated in an 8-week ADF protocol where food was provided on the fast day. RESULTS: Body weight decreased (P < 0.0001) by 3.9 ± 0.6 kg after 8 weeks of diet. Reductions (P < 0.05) in fat mass (-2.2 ± 0.2 kg), fat free mass (-1.4 ± 0.2 kg), visceral fat mass (-0.1 ± 0.1 kg), and resting metabolic rate (RMR; -104 ± 28 kcal/day) were also observed. Fasting leptin and insulin decreased (P < 0.05), while AUC ghrelin levels increased (P < 0.05). Despite these metabolic changes, there was no increase in subjective hunger by the end of the study. Furthermore, fullness and PYY increased (P < 0.05). Fat free mass and RMR were not related to hunger or ghrelin at any time point. CONCLUSION: These findings suggest that the absence of a compensatory increase in hunger in conjunction with an increase in sensations of fullness may contribute to the weight loss efficacy of an 8-week ADF regimen.


Subject(s)
Fasting , Ghrelin/blood , Hunger , Insulin/blood , Leptin/blood , Peptide YY/blood , Satiation , Basal Metabolism , Blood Glucose/metabolism , Body Composition , Body Mass Index , Body Weight , Diet , Diet Records , Exercise , Female , Humans , Male , Middle Aged , Patient Compliance
18.
Obes Res Clin Pract ; 10(4): 476-80, 2016.
Article in English | MEDLINE | ID: mdl-26385599

ABSTRACT

This study examined what characteristics predict weight loss success with alternate day fasting (ADF). Four 8-week trials of ADF (n=121) were included in the analysis. Subjects aged 50-59 y achieved greater (P=0.01) weight loss than other age groups. Males and females achieved similar weight loss. Caucasian subjects achieved greater (P=0.03) weight loss than other races. Baseline body weight and baseline BMI did not predict degree of weight loss achieved with the diet. These findings may help clinicians to decide which population groups may benefit most from an ADF approach.


Subject(s)
Diet, Reducing/methods , Energy Intake , Fasting , Feeding Behavior , Obesity/diet therapy , Racial Groups , Weight Loss , Adult , Aged , Body Mass Index , Female , Humans , Male , Middle Aged , White People
19.
Nutr J ; 14: 44, 2015 May 06.
Article in English | MEDLINE | ID: mdl-25943396

ABSTRACT

BACKGROUND: Alternate day fasting (ADF; ad libitum intake "feed day" alternated with 75% restriction "fast day"), is effective for weight loss, but the safety of the diet has been questioned. Accordingly, this study examined occurrences of adverse events and eating disorder symptoms during ADF. FINDINGS: Obese subjects (n = 59) participated in an 8-week ADF protocol where food was provided on the fast day. Body weight decreased (P < 0.0001) by 4.2 ± 0.3%. Some subjects reported constipation (17%), water retention (2%), dizziness (<20%), and general weakness (<15%). Bad breath doubled from baseline (14%) to post-treatment (29%), though not significantly. Depression and binge eating decreased (P < 0.01) with ADF. Purgative behavior and fear of fatness remained unchanged. ADF helped subjects increase (P < 0.01) restrictive eating and improve (P < 0.01) body image perception. CONCLUSIONS: Therefore, ADF produces minimal adverse outcomes, and has either benign or beneficial effects on eating disorder symptoms.


Subject(s)
Diet, Reducing/adverse effects , Diet, Reducing/methods , Fasting/adverse effects , Feeding Behavior/psychology , Weight Loss , Adult , Aged , Body Image/psychology , Body Mass Index , Body Weight/physiology , Constipation/epidemiology , Constipation/etiology , Depression/epidemiology , Depression/etiology , Dizziness/epidemiology , Dizziness/etiology , Energy Intake/physiology , Feeding and Eating Disorders/epidemiology , Feeding and Eating Disorders/etiology , Female , Humans , Male , Middle Aged
20.
Crit Rev Food Sci Nutr ; 55(14): 2004-13, 2015.
Article in English | MEDLINE | ID: mdl-24922183

ABSTRACT

The American Diabetes Association (ADA) and the National Cholesterol Education Program (NCEP) have each outlined a set of dietary recommendations aimed at improving glycemic control and blood lipids, respectively. However, traditional vegan diets (low-fat diets that proscribe animal product consumption) are also effective at improving glycemic control, and dietary portfolios (vegan diets that contain prescribed amounts of plant sterols, viscous fibers, soy protein, and nuts) are also effective at improving blood lipids. The purpose of this review was to compare the effects of traditional vegan diets and dietary portfolios with ADA and NCEP diets on body weight, blood lipids, blood pressure, and glycemic control. The main findings are that traditional vegan diets appear to improve glycemic control better than ADA diets in individuals with type 2 diabetes mellitus (T2DM), while dietary portfolios have been consistently shown to improve blood lipids better than NCEP diets in hypercholesterolemic individuals.


Subject(s)
Diabetes Mellitus, Type 2/diet therapy , Diet, Vegan , Hyperglycemia/diet therapy , Hyperlipidemias/diet therapy , Lipids/blood , Blood Glucose , Blood Pressure , Body Weight , Diabetes Mellitus, Type 2/complications , Humans , Hyperglycemia/blood , Hyperglycemia/complications , Hyperlipidemias/blood , Hyperlipidemias/complications
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