Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults

Healthy Clinical Trial

Official title:

Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03042494
• Other study ID #: REB16-0388
• Status: Completed
• Phase: N/A
• Start date: May 15, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: May 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Control
Isocaloric food without the test prebiotic.
• Prebiotic
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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	General Mills

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline fecal bifidobacteria at 4 weeks	Assessed with 16S rRNA sequencing.	4 weeks in cross-over design
Secondary	Change in baseline fecal short chain fatty acid concentrations at 4 weeks	Analyzed with gas chromatography/mass spectrophotometry	4 weeks in cross-over design
Secondary	Change in baseline gastrointestinal tolerance at 4 weeks	Analyzed with questionnaire	4 weeks in cross-over design
Secondary	Change in baseline quality of life rating at 4 weeks	Measured with SF-36 questionnaire	4 weeks in cross-over design