Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults

NCT03042494 | Completed

• 1 other identifier: REB16-0388
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Prebiotic; Gut microbiota; Dietary fiber; Gastrointestinal tolerance

Outcome Measures

Primary Outcomes (1)

• Change in baseline fecal bifidobacteria at 4 weeks

  Assessed with 16S rRNA sequencing.

  4 weeks in cross-over design

Secondary Outcomes (3)

• Change in baseline fecal short chain fatty acid concentrations at 4 weeks

  4 weeks in cross-over design

• Change in baseline gastrointestinal tolerance at 4 weeks

  4 weeks in cross-over design

• Change in baseline quality of life rating at 4 weeks

  4 weeks in cross-over design

Study Arms (2)

Control

PLACEBO COMPARATOR

Isocaloric food without the test prebiotic.

Dietary Supplement: Control

Prebiotic

EXPERIMENTAL

Prebiotic consumed as one daily serving of 7 g in Group 1 and consumed as one daily serving of 2.5-3 g in Group 2.

Dietary Supplement: Prebiotic

Interventions

Control DIETARY_SUPPLEMENT

Isocaloric food without the test prebiotic.

Control

Prebiotic DIETARY_SUPPLEMENT

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.

Prebiotic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• General Mills: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (1)

• 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.

  PMID: 32320024 DERIVED

MeSH Terms

Interventions

Prebiotics

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Raylene Reimer, PhD, RD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Crossover design with 4 week washout period.

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 3, 2017
• Study Start: May 15, 2016
• Primary Completion: May 25, 2017
• Study Completion: December 31, 2022
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)