Meta-analysis of Soluble Fiber Consumption on Body Weight, Glycemia, and Insulinemia in Overweight and Obese Adults.

Study Overview
=================
Brief Summary
-----------------
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.

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.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Soluble Fiber
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Peer-reviewed randomized controlled trials (RCTs) will be included in the systematic review and meta-analysis if they involve participants who are: 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). Weight stable and not actively trying to lose weight at screening. Without physician-diagnosed chronic conditions at screening (e.g., dyslipidemia, hypertension, type 2 diabetes, and cardiovascular disease). 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: Studies conducted in animals. Mechanistic research. Human trials involving pregnant women, breastfeeding women, or children. Conference proceedings. Articles not published in English. Studies less than 1 week in duration. Studies that pool outcome measure data for healthy weight and overweight and obese individuals. Studies involving whole food treatments or high fiber profile diets. Weight loss interventions involving other tactics, such as counseling or energy restriction.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Soluble Fiber Treatment<br>Participants receiving soluble fiber. | Other: Soluble Fiber<br>* Participants receiving soluble fiber.<br>|
| Placebo Treatment<br>Participants receiving placebo. | Other: Placebo<br>* Participants receiving placebo.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (kg/m2) |  | ≥ 1 week | 
| Body weight (kg) |  | ≥ 1 week | 
| Body fat (% fat mass) |  | ≥ 1 week | 
| Waist circumference (cm) |  | ≥ 1 week | 
| Fasting glucose (mmol/l) |  | ≥ 1 week | 
| Fasting insulin (pmol/l) |  | ≥ 1 week | 
| Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) |  | ≥ 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dietary Fiber, Soluble Fiber, Body Mass Index, Body Weight, Blood Glucose, Insulin