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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03003897
Other study ID # Soluble Fiber Review
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2016
Est. completion date October 2017

Study information

Verified date July 2018
Source University of Illinois at Urbana-Champaign
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 609
Est. completion date October 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Soluble Fiber
Participants receiving soluble fiber.
Placebo
Participants receiving placebo.

Locations

Country Name City State
United States University of Illinois, Urbana-Champaign Urbana Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Body mass index (kg/m2) = 1 week
Primary Body weight (kg) = 1 week
Primary Body fat (% fat mass) = 1 week
Primary Waist circumference (cm) = 1 week
Primary Fasting glucose (mmol/l) = 1 week
Primary Fasting insulin (pmol/l) = 1 week
Primary Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) = 1 week
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