An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI… (NCT07563855) | Clinical Trial Compass
RecruitingNot Applicable
An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes
United States133 participantsStarted 2026-04
Plain-language summary
The purpose of this study is to:
1. Understand the participant experience using a health and wellness product and effects of the study product on GLP-1 users and those trying to lose weight
2. Understand how participants may use and accept a health and wellness product
3. Understand the side effects of a health and wellness product
4. Evaluate the quality and effects of a health and wellness product on participant health through self-reported measures (electronic surveys) and biomarker collections.
Who can participate
Age range21 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults, at least 21-75 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities.
* Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
* Resides in the United States
* Has the opportunity for at least 30% improvement in their primary health outcome
* One of the following:
* Currently taking a GLP-1 for at least 3 months with no plans to stop or switch current GLP-1
* Expressing the interest to lose weight, but not currently taking a GLP-1 in the last 6 months and with no plans to start taking a GLP-1
* Must be willing to complete a biomarker collection (stool and blood) at 2 timepoints during the study (baseline and end of study)
* Expresses a willingness to take the study product everyday for 4 weeks
Exclusion Criteria:
* Report being pregnant, trying to become pregnant, or breastfeeding
* Unable to provide a valid US shipping address and mobile phone number
* Reports current enrollment in another clinical trial
* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
* Unable to read and understand English at a 7th grade level
* Reports enrollment, current or within in the past 30 days, in another clinical trial
* Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
* Reports a diagnosis of cardiac dysfunction, liver or kidney diseas…
What they're measuring
1
PROMIS Constipation 9A
Timeframe: At baseline and weeks 1-4 of the intervention