Clinical trial NCT03042494: Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults
Official title: Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Prebiotic
Gut microbiota
Dietary fiber
Gastrointestinal tolerance
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: General Mills
First posted: 2017-02-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover design with 4 week washout period.
Primary purpose: TREATMENT

Brief summary: In recent years, the importance of the gut microbiota to human health has been demonstrated. In adulthood, the microbial profile is relatively stable, yet can be transiently altered by factors such as diet or antibiotic treatment. Such changes may be beneficial, as gut microbiota has been shown to differ in normal versus disease states including inflammatory bowel disease, obesity, type 2 diabetes and fatty liver disease. Given this relationship, there is intense interest in designing interventions that positively influence the gut microbial profile. Prebiotics are non-digestible, fermentable oligo- and polysaccharides that alter the colonic environment in favour of health-promoting bacterial species, such as bifidobacteria which selectively ferment prebiotics. Given the ability of prebiotics to beneficially alter the microbial profile, there is a need to identify the dosing requirements to positively modulate the gut microbiota. This study will test the effect of two doses of prebiotic on gut microbiota taxonomy and diversity.

Detailed description: The primary objective is to determine the effect of 4 week intake of a moderate dose (7 g/d) or low dose (2.5-3 g/d) of prebiotic on gut microbiota profiles in healthy adults compared to a non-prebiotic containing control.

The primary outcome is change in microbial composition (measured via 16S rRNA sequencing).

The secondary outcomes are change in gastrointestinal (GI) tolerance (measured via questionnaire); change in fecal short chain fatty acids; and change in quality of life.

This study will consist of two separate trials of 12 week duration. Each trial will be performed in a double-blind, randomized, placebo-controlled crossover manner with a 4 week intervention period followed by a 4 week wash-out period and final 4 week cross over.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects who are regular snack consumers
* Not obese (BMI ≥ 18.5 kg/m2 and ≤ 29.9 kg/m2)
* 18 and 65 years of age
* Stable bodyweight for at least 3-months prior to the study.

Exclusion Criteria:

* Chronic disease including but not limited to type 1 or 2 diabetes, cardiovascular disease, liver or pancreas disease.
* Major gastrointestinal surgery
* Pregnant or lactating
* Antibiotic use in the preceding 3 months
* Currently consume probiotic or prebiotics supplements
* Currently consume more than 15 g/d of fiber in women and 18 g/d in men
* Are following a diet or exercise regime designed for weight loss
* Have a BMI greater than 29.9 kg/m2.
* Subjects who are required to start an antibiotic regime during the study will be withdrawn.

Primary outcomes:
measure: Change in baseline fecal bifidobacteria at 4 weeks
timeFrame: 4 weeks in cross-over design
Secondary outcomes:
measure: Change in baseline fecal short chain fatty acid concentrations at 4 weeks
timeFrame: 4 weeks in cross-over design
measure: Change in baseline gastrointestinal tolerance at 4 weeks
timeFrame: 4 weeks in cross-over design
measure: Change in baseline quality of life rating at 4 weeks
timeFrame: 4 weeks in cross-over design
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Raylene Reimer, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reimer RA, Soto-Vaca A, Nicolucci AC, Mayengbam S, Park H, Madsen KL, Menon R, Vaughan EE. Effect of chicory inulin-type fructan-containing snack bars on the human gut microbiota in low dietary fiber consumers in a randomized crossover trial. Am J Clin Nutr. 2020 Jun 1;111(6):1286-1296. doi: 10.1093/ajcn/nqaa074.