Yeast Mannans and Stool Frequency
Efficacy of Yeast Mannan Supplementation on Increasing Stool Frequency in Generally Healthy Adults: A Randomized Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Wendy J Dahl, PhD
- Phone Number: 352-294-3707
- Email: wdahl@ufl.edu
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32611
- Department of Food Science and Human Nutrition
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults who report a stool frequency of ≤ 1 per day.
- Able to provide written informed consent in English.
- Willingness to consume 1 supplement (12 g of yeast mannans or control) daily for 28 days.
- Willingness to maintain their usual diet and physical activity patterns throughout the study and refrain from the consumption of any yeast-based foods (e.g. Marmite or Vegemite) or yeast extract supplements.
- Willing to comply with study procedures, including stool and urine colle
Exclusion Criteria:
- Stool frequency of < 3 per week
- Yeast allergy
- Vegan dietary pattern
- Self-reported kidney disease
- Elite athletes or long-distance runners
- Use of antibiotic drugs within 1 month of screening
- Current use of laxatives or antidiarrheal medications
- Use of other investigational products within 3 months of the screening
- Previously or currently being treated for intestinal diseases or conditions, including irritable bowel disease (i.e., IBS-D or IBS-mixed), Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal cancer.
- Previous gastrointestinal surgery (e.g., gastric bypass, fundoplication, bowel resection).
- Current cancer treatment.
- Currently pregnant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Yeast mannan supplementation
Yeast cell wall fraction obtained from Saccharomyces cerevisiae containing mannan-oligosaccharides and mannoproteins will be supplemented at 12 g/day.
|
Yeast cell wall fraction of manno-oligosaccharides and mannoproteins supplemented at 12 g/day.
Other Names:
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Placebo Comparator: Control supplementation
The control supplement, containing yeast protein, yeast extract, and maltodextrin, will be provided at 12 g/day.
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A supplement containing yeast protein, yeast extract, and maltodextrin, provided at 12 g/day.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Defecation frequency
Time Frame: From enrollment to the end of treatment at 6 weeks.
|
Mean daily defecation frequency
|
From enrollment to the end of treatment at 6 weeks.
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- IRB202500359
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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