Radicle GI HealthTM VNB: A Randomized, Double-Blind, Placebo- Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Constipation and Related Health Outcomes
Radicle Science
Summary
Radicle GI HealthTM VNB: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on constipation and related health outcomes
Description
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (2) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding wi…
Eligibility
- Age range
- 21–105 years
- Sex
- All
- Healthy volunteers
- Yes
3.1 Inclusion Participants must meet all the following criteria: * Adults, at least 21 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 PROs (male vs female) employed, when needed * Resides in the United States * Has the opportunity for at least 30% improvement in their primary health outcome * Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study 3.2 Exclusion Individuals who report any o…
Interventions
- Dietary SupplementPlacebo GI Health Control
Participants will use their Placebo GI Health Control product as directed for a period of 4 weeks
- Dietary SupplementActive GI Health Product
Participants will use their Active GI Health Product as directed for a period of 4 weeks
Location
- Radicle Science Inc.Del Mar, California