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OpenTrials
Completed

NCT Number: NCT03003897

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

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Illinois, Urbana-Champaign

Urbana, Illinois, 61801, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Soluble Fiber

Other

Participants receiving soluble fiber.

Placebo

Other

Participants receiving placebo.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 28, 2016
Registry last updated
Jul 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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