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Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03042494
Recruitment Status : Active, not recruiting
First Posted : February 3, 2017
Last Update Posted : April 27, 2021
Sponsor:
Collaborator:
General Mills
Information provided by (Responsible Party):
Dr. Raylene Reimer, University of Calgary

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Control Dietary Supplement: Prebiotic Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover design with 4 week washout period.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults
Actual Study Start Date : May 15, 2016
Actual Primary Completion Date : May 25, 2017
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Placebo Comparator: Control
Isocaloric food without the test prebiotic.
Dietary Supplement: Control
Isocaloric food without the test prebiotic.

Experimental: Prebiotic
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
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 Outcome Measures :
  1. Change in baseline fecal bifidobacteria at 4 weeks [ Time Frame: 4 weeks in cross-over design ]
    Assessed with 16S rRNA sequencing.


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042494


Locations
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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Sponsors and Collaborators
University of Calgary
General Mills
Investigators
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Principal Investigator: Raylene Reimer, PhD, RD University of Calgary
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Raylene Reimer, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT03042494    
Other Study ID Numbers: REB16-0388
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Raylene Reimer, University of Calgary:
Prebiotic
Gut microbiota
Dietary fiber
Gastrointestinal tolerance