Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults

University of Calgary

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Control

Dietary Supplement: Prebiotic

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03042494

REB16-0388

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.