Clinical trial NCT03003897: Meta-analysis of Soluble Fiber Consumption on Body Weight, Glycemia, and Insulinemia in Overweight and Obese Adults.
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Dietary Fiber
Soluble Fiber
Body Mass Index
Body Weight
Blood Glucose
Insulin
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 609
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults ≥ 18 years of age with overweight and obesity but without physician diagnosed chronic disease at screening.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Body mass index (kg/m2)
timeFrame: ≥ 1 week
measure: Body weight (kg)
timeFrame: ≥ 1 week
measure: Body fat (% fat mass)
timeFrame: ≥ 1 week
measure: Waist circumference (cm)
timeFrame: ≥ 1 week
measure: Fasting glucose (mmol/l)
timeFrame: ≥ 1 week
measure: Fasting insulin (pmol/l)
timeFrame: ≥ 1 week
measure: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: ≥ 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois, Urbana-Champaign
state: Illinois
Study officials:
References:
citation: 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.