NCT06283732
Completed
Not Applicable
A Clinical Study to Assess the Effect of a Supplement on Digestive Health, Overall Well-being, and Participant Experience.
Amway Corp1 site in 1 country70 target enrollmentNovember 15, 2023
ConditionsDigestive System Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Digestive System Disease
- Sponsor
- Amway Corp
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Digestive Health Improvement
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The study aims to evaluate the effectiveness of a dietary supplement (greens powder), on improving digestive health, quality of life, energy levels, and satiety over a 14-day period. Participants, aged 18-65 and experiencing mild digestive issues, will consume the greens powder daily and report outcomes through diaries and questionnaires.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female.
- •Aged 18-65 years.
- •Willing to comply with study requirements.
- •No known allergies to the ingredients listed in the product.
- •Self-reported mild digestive issues (e.g., occasional bloating, stomach discomfort, occasional constipation, or occasional diarrhea).
- •Generally healthy - do not live with any uncontrolled chronic disease .
Exclusion Criteria
- •Pre-existing chronic conditions that would prevent adherence to the protocol, including oncological and psychiatric disorders.
- •Known severe allergic reactions that require an Epi-Pen.
- •Women who are pregnant, breastfeeding, or attempting to conceive.
- •History of severe diagnosed digestive disorders (e.g., IBS, IBD, Crohn's disease) or gastrointestinal-tract surgeries.
- •Unwillingness to follow the study protocol.
- •Invasive medical procedure within the last three weeks or planning one during the study period.
- •History of substance abuse.
- •Current participation or planning to participate in another research study.
- •Regular consumption of probiotics, fiber, or prebiotic supplements within 3 weeks of the study.
- •Regular intake of medications that may interfere with the study or study product (e.g., anticoagulants, laxatives, sedatives, beta-blockers, anti-acids) .
Outcomes
Primary Outcomes
Digestive Health Improvement
Time Frame: 14 days from the start of intervention
Measure the change in digestive health using daily diaries and the Bristol Stool Scale (BSS).
Secondary Outcomes
- Quality of Life and Well-being Enhancement(14 days from the start of intervention)
Study Sites (1)
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