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

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ClinicalTrials.gov Identifier: NCT03003897
Recruitment Status : Active, not recruiting
First Posted : December 28, 2016
Last Update Posted : May 31, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Obesity Other: Soluble Fiber Other: Placebo

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : January 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Body mass index (kg/m2) [ Time Frame: ≥ 1 week ]
  2. Body weight (kg) [ Time Frame: ≥ 1 week ]
  3. Body fat (% fat mass) [ Time Frame: ≥ 1 week ]
  4. Waist circumference (cm) [ Time Frame: ≥ 1 week ]
  5. Fasting glucose (mmol/l) [ Time Frame: ≥ 1 week ]
  6. Fasting insulin (pmol/l) [ Time Frame: ≥ 1 week ]
  7. Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: ≥ 1 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults ≥ 18 years of age with overweight and obesity but without physician diagnosed chronic disease at screening.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003897

United States, Illinois
University of Illinois, Urbana-Champaign
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT03003897     History of Changes
Other Study ID Numbers: Soluble Fiber Review
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data has been previously published in the randomized controlled trials we intend to analyze.

Keywords provided by University of Illinois at Urbana-Champaign:
Dietary Fiber
Soluble Fiber
Body Mass Index
Body Weight
Blood Glucose

Additional relevant MeSH terms:
Body Weight
Nutrition Disorders
Signs and Symptoms