NCT03003897

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
609

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

July 10, 2018

Status Verified

July 1, 2018

Enrollment Period

1.6 years

First QC Date

October 28, 2016

Last Update Submit

July 6, 2018

Conditions

Keywords

Dietary FiberSoluble FiberBody Mass IndexBody WeightBlood GlucoseInsulin

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (2)

Soluble Fiber Treatment

Participants receiving soluble fiber.

Other: Soluble Fiber

Placebo Treatment

Participants receiving placebo.

Other: Placebo

Interventions

Participants receiving soluble fiber.

Soluble Fiber Treatment
PlaceboOTHER

Participants receiving placebo.

Placebo Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois, Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (1)

  • Thompson SV, Hannon BA, An R, Holscher HD. Effects of isolated soluble fiber supplementation on body weight, glycemia, and insulinemia in adults with overweight and obesity: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2017 Dec;106(6):1514-1528. doi: 10.3945/ajcn.117.163246. Epub 2017 Nov 1.

MeSH Terms

Conditions

ObesityBody WeightInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2016

First Posted

December 28, 2016

Study Start

January 1, 2016

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

July 10, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

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

Locations