Evaluation of the the Efficacy of a Digestive Health Supplement in Healthy Subjects (NCT06680219) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the the Efficacy of a Digestive Health Supplement in Healthy Subjects
United Kingdom50 participantsStarted 2024-02-21
Plain-language summary
The objective of this study is to evaluate the efficacy of a digestive health supplement via waist circumference measurements, daily bowel habit and symptom logs, and self-perception questionnaires (SPQ) over 4 weeks.
To test for the following claims:
* Reduction of bloating after only one use.
* SPQ claims - to be determined by the sponsor.
* Improvement to a range of upper and lower gastrointestinal symptoms (heartburn, belching, bloating, nausea, vomiting, flatulence, intestinal cramps, urge to defecate, loose stool, and diarrhea)
* Clinically proven formulation
* Supports relief of bloating discomfort
* Supports quick and effective reduction in bloating related to food intake
* Study shows X% severity reduction in abdominal bloating
* Helps support a reduction in days experiencing bloating
* Supports a reduction in abdominal discomfort
* X% of participants reported a reduction in bloating during the study
* Supports a reduction in waist circumference, related to bloating
Please note that it is the responsibility of the sponsor to determine the testing and study designs required for submission to entities such as the Home Shopping Network, QVC, etc.
Who can participate
Age range20 Years – 60 Years
SexALL
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Inclusion criteria
✓. Healthy male and female subjects aged 20 - 60 years old including a range of ethnicities.
. Treatment or medication containing sympathomimetics, antihistamines or corticosteroids in the seven days prior to study start.
✕. Known allergies or hypersensitivity to dietary supplements, similar materials, or their ingredients including, but not limited to, hazelnuts, peanuts and pomegranates (family Lythraceae).
✕. Subject has allergies or sensitivity (other than bloating/indigestion issues/GI discomfort) to the ingredients of the test meal.
✕. Insulin dependent diabetes.
✕. Subjects with history of any gastrointestinal surgery, gastrointestinal illness which in the opinion of the Investigator would affect the digestive and absorption processes of the body (i.e., Gastric bypass, Gastroenteritis, Irritable Bowel Syndrome, Celiac Disease).
✕. Medical condition that may affect study data or subject safety which in the opinion of the Investigator would compromise the safety of the subject or study results.
✕. History of poor cooperation, non-compliance, or unreliability.