An Open Label Direct-to-Consumer Study Assessing the Impa... | NCT07563855

Status Module

Name	Class
Radicle Science Inc.	UNKNOWN

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GLP-1 Users and Non-users	Experimental	Participants currently taking a GLP-1 for 3 months or longer, or wishing to lose weight, but not currently on a GLP-1	Dietary Supplement: A ready-to-mix beverage containing protein, fiber, and electrolytes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
A ready-to-mix beverage containing protein, fiber, and electrolytes	Dietary Supplement	Subjects will consume the ready-to-mix beverage ad-libitum over the 4-week study period.	GLP-1 Users and Non-users

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PROMIS Constipation 9A	A patient reported outcome measure designed to assess frequency, severity, impact, and discomfort cause by gastrointestinal constipation symptoms over 7 days. The scale consists of 9 items, scored 1 to 5, with 1 being associated with a better outcome and 5 being associated with a worse outcome.	At baseline and weeks 1-4 of the intervention

Secondary Outcomes

Measure	Description	Time Frame
Digestion-associated Quality of Life Questionnaire	A validated tool designed to assess impact of gastrointestinal symptoms on the quality of life of healthy individuals over 7 days. The questionnaire consists of 9 items, scaled from Never to Always, with Never being associated with a better outcome and 1 being associated with a worse outcome.	At baseline and weeks 1-4 of the intervention

Other Outcomes

Measure	Description	Time Frame
Adverse Events	Documented changes in health and symptoms through self-report	From enrollment through completion of the study, average 5 weeks.
Evaluation of an at-home Tiny Health Stool kit	An evaluation of the gut microbiome using shotgun metagenomic sequencing. Used to support exploratory research objectives by complementing participant-reported GI symptoms and behavioral outcomes with biological measures

Eligibility Module

Eligibility Criteria

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 disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.
NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.
Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, Diabetic medications to treat Type 1 or Type 2 diabetes , oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products
Reports current use, or use within the past 30 days, of whey protein and/or similar product(s) to the study product that may limit the effects of the study products and/or pose a safety risk
Reports taking an antibiotic or probiotic in the last 4 weeks
Lack of reliable daily access to the internet

ID	Term
D003248	Constipation
D001835	Body Weight
D001519	Behavior

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004043	Dietary Fiber
D004573	Electrolytes

ID	Term
D004040	Dietary Carbohydrates
D002241	Carbohydrates
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages
D007287	Inorganic Chemicals