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

Completed

• Conditions: Obesity
• Interventions: Other: Soluble Fiber; Other: Placebo

• Registration Number: NCT03003897
• Lead Sponsor: University of Illinois at Urbana-Champaign

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-10-28
• Study First Submitted QC: 2016-12-21
• Study First Posted: 2016-12-28
• Primary Completion: 2017-08
• Study Completion: 2017-10
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-06
• Last Update Posted: 2018-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 609

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Soluble Fiber Treatment	Soluble Fiber	Participants receiving soluble fiber.
Placebo Treatment	Placebo	Participants receiving placebo.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Illinois, Urbana-Champaign; 🇺🇸 Urbana, Illinois, United States