Healthy
Conditions
Keywords
Prebiotic, Gut microbiota, Dietary fiber, Gastrointestinal tolerance
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.
Interventions
DIETARY_SUPPLEMENTControl
Isocaloric food without the test prebiotic.
DIETARY_SUPPLEMENTPrebiotic
Prebiotic consumed as 7 g/d in a snack food in Group 1 and consumed as 2.5-3 g/d in a snack food in Group 2.
Sponsors
General Mills
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Crossover design with 4 week washout period.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in baseline fecal bifidobacteria at 4 weeks | 4 weeks in cross-over design | Assessed with 16S rRNA sequencing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in baseline fecal short chain fatty acid concentrations at 4 weeks | 4 weeks in cross-over design | Analyzed with gas chromatography/mass spectrophotometry |
| Change in baseline gastrointestinal tolerance at 4 weeks | 4 weeks in cross-over design | Analyzed with questionnaire |
| Change in baseline quality of life rating at 4 weeks | 4 weeks in cross-over design | Measured with SF-36 questionnaire |
Countries
Canada
Outcome results
None listed