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A Study to Evaluate Acute and Short-term Efficacy of Digest Gold on Postprandial Abdominal Distension and Subjective Bloating in Healthy Adults
Sponsor: Enzymedica
Summary
The goal of this clinical trial is to investigate the acute and short-term efficacy of Digest Gold on postprandial abdominal distension and subjective bloating in healthy adults. The main question it aims to answer is what is the difference between Digest Gold and placebo in time-to-relief of subjective bloating (time = 0 -120 minutes postprandial), as assessed by the bloating Likert scale?Researchers will compare Digest Gold to a placebo to see its effects on postprandial abdominal distension and bloating. Participants will: * Consume Digest Gold and a placebo. * Have height, weight, and waist circumference measured. * Have blood pressure and heart rate measured. * Provide blood samples. * Provide a fecal sample. * Complete study questionnaires assessing gastrointestinal symptoms and subjective bloating. * Record their daily food intake. * Complete a breath test to assess gastrointestinal parameters.
Official title: A Randomized, Triple-blind, Placebo-controlled, Cross-over Study to Evaluate Acute and Short-term Efficacy of Digest Gold on Postprandial Abdominal Distension and Subjective Bloating in Healthy Adults
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-09
Completion Date
2026-11
Last Updated
2026-09-21
Healthy Volunteers
Yes
Interventions
Digest Gold
At Visit 1 (Day 1 of Period 1) and Visit 3 (Day 1 of Period 2), study staff will provide participants with one capsule of study product with water to be consumed with the first bite of the standardized meal. Starting on Day 2 of Period 1, participants will be instructed to take one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner) until Day 6 of Period 1. After a minimum 10-day wash out, participants will return to the study site and will be provided with one capsule of study product to be taken with water at the first bite of the standardized meal. Participants will be instructed to resume daily consumption of the alternate study product (one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner)) from Day 2 until Day 6 of Period 2.
Placebo
At Visit 1 (Day 1 of Period 1) and Visit 3 (Day 1 of Period 2), study staff will provide participants with one capsule of study product with water to be consumed with the first bite of the standardized meal. Starting on Day 2 of Period 1, participants will be instructed to take one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner) until Day 6 of Period 1. After a minimum 10-day wash out, participants will return to the study site and will be provided with one capsule of study product to be taken with water at the first bite of the standardized meal. Participants will be instructed to resume daily consumption of the alternate study product (one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner)) from Day 2 until Day 6 of Period 2.