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Completed

NCT Number: NCT03042494

Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control

Dietary Supplement

Isocaloric food without the test prebiotic.

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.

Primary outcomes

  1. Change in baseline fecal bifidobacteria at 4 weeks

    Time frame: 4 weeks in cross-over design

    Assessed with 16S rRNA sequencing.

Secondary outcomes

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

    Time frame: 4 weeks in cross-over design

    Analyzed with gas chromatography/mass spectrophotometry

  2. Change in baseline gastrointestinal tolerance at 4 weeks

    Time frame: 4 weeks in cross-over design

    Analyzed with questionnaire

  3. Change in baseline quality of life rating at 4 weeks

    Time frame: 4 weeks in cross-over design

    Measured with SF-36 questionnaire

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • General Mills

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2022
First posted
Feb 3, 2017
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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