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

July 6, 2018 updated by: University of Illinois at Urbana-Champaign

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

609

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • University of Illinois, Urbana-Champaign

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults ≥ 18 years of age with overweight and obesity but without physician diagnosed chronic disease at screening.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Soluble Fiber Treatment
Participants receiving soluble fiber.
Other: Soluble Fiber
Participants receiving soluble fiber.
Placebo Treatment
Participants receiving placebo.
Other: Placebo
Participants receiving placebo.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Urbana-Champaign

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

October 28, 2016

First Submitted That Met QC Criteria

December 21, 2016

First Posted (Estimate)

December 28, 2016

Study Record Updates

Last Update Posted (Actual)

July 10, 2018

Last Update Submitted That Met QC Criteria

July 6, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soluble Fiber Review

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data has been previously published in the randomized controlled trials we intend to analyze.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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