MedPath

Yeast Mannans and Stool Frequency

Not Applicable
Not yet recruiting
Conditions
Defecation Frequency
Registration Number
NCT06911177
Lead Sponsor
University of Florida
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
70
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Defecation frequencyFrom enrollment to the end of treatment at 6 weeks.

Mean daily defecation frequency

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Department of Food Science and Human Nutrition

🇺🇸

Gainesville, Florida, United States

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