Obesity Clinical Trial
Official title:
Effects of Soluble Fiber Consumption on Body Weight, Glycemia, and Insulinemia in Adults With Overweight and Obesity: a Systematic Review and Meta-analysis of Randomized Controlled Trials.
Verified date | July 2018 |
Source | University of Illinois at Urbana-Champaign |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Dietary fiber intake is protective against overweight and obesity; however, a significant fiber gap exists between consumption and recommended intake values. Soluble fiber beneficially impacts metabolism, and supplementation may be a feasible approach to improve body composition and glycemia in overweight and obese individuals. The investigators will evaluate results of randomized controlled trials (RCTs) of soluble fiber supplementation among overweight and obese adults for outcomes related to weight management (e.g. body mass index [BMI], body weight, body fat percentage, waist circumference) and glucose and insulin homeostasis (e.g. fasting glucose, homeostasis model assessment of insulin resistance [HOMA-IR], fasting insulin) through systematic review and meta-analysis.
Status | Completed |
Enrollment | 609 |
Est. completion date | October 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Peer-reviewed randomized controlled trials (RCTs) will be included in the systematic review and meta-analysis if they involve participants who are: 1. Overweight or obese (BMI = 25.0 kg/m2 for U.S. populations and = 23.0 kg/m2 for Asian populations and/or waist circumference = 40 inches (94 cm) in men or = 35 inches (80 cm) in women and/or waist-to-hip ratio = 0.90 in men or = 0.85 in women). 2. Weight stable and not actively trying to lose weight at screening. 3. Without physician-diagnosed chronic conditions at screening (e.g., dyslipidemia, hypertension, type 2 diabetes, and cardiovascular disease). 4. Included studies will be soluble fiber supplementation interventions that are controlled feeding studies or conducted among free-living subjects that provide data for outcomes of interest. Exclusion Criteria: Studies will be excluded from the systematic review and meta-analysis if they meet any of the following criteria: 1. Studies conducted in animals. 2. Mechanistic research. 3. Human trials involving pregnant women, breastfeeding women, or children. 4. Conference proceedings. 5. Articles not published in English. 6. Studies less than 1 week in duration. 7. Studies that pool outcome measure data for healthy weight and overweight and obese individuals. 8. Studies involving whole food treatments or high fiber profile diets. 9. Weight loss interventions involving other tactics, such as counseling or energy restriction. |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois, Urbana-Champaign | Urbana | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Urbana-Champaign |
United States,
Thompson SV, Hannon BA, An R, Holscher HD. Effects of isolated soluble fiber supplementation on body weight, glycemia, and insulinemia in adults with overweight and obesity: a systematic review and meta-analysis of randomized controlled trials. Am J Clin — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body mass index (kg/m2) | = 1 week | ||
Primary | Body weight (kg) | = 1 week | ||
Primary | Body fat (% fat mass) | = 1 week | ||
Primary | Waist circumference (cm) | = 1 week | ||
Primary | Fasting glucose (mmol/l) | = 1 week | ||
Primary | Fasting insulin (pmol/l) | = 1 week | ||
Primary | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | = 1 week |
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