Defecation Frequency
Conditions
Keywords
yeast mannan, stool frequency, transit time, microbiota
Brief summary
Findings from an open-label pilot study of 20 adults suggested that supplementation with 15 g/day of yeast mannans was highly tolerable and demonstrated specific modulation of the microbiota and increased stool frequency in a subset of subjects reporting ≤1 stool per day at baseline. The primary aim of this randomized, double-blind, controlled trial is to determine if yeast mannan supplementation at 12 g/day will increase stool frequency in generally healthy adults reporting ≤1 stool per day. Secondary aims will determine the effect of yeast mannans on intestinal transit time, gastrointestinal symptoms, fecal microbiota composition, and urinary and fecal metabolomics.
Interventions
DIETARY_SUPPLEMENTYeast mannan
Yeast cell wall fraction of manno-oligosaccharides and mannoproteins supplemented at 12 g/day.
DIETARY_SUPPLEMENTControl (placebo)
A supplement containing yeast protein, yeast extract, and maltodextrin, provided at 12 g/day.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Defecation frequency | From enrollment to the end of treatment at 6 weeks. | Mean daily defecation frequency |
Countries
United States
Outcome results
None listed