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.
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
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)
Single group
A ready-to-mix beverage containing protein, fiber, and electrolytes
Dietary supplementSubjects will consume the ready-to-mix beverage ad-libitum over the 4-week study period.
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.
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.
PROMIS Belly Pain 5A
A patient reported outcome measure designed to assess the severity of belly pain experienced by participants over 7 days. The scale consists of 5 items, scored 1 to 5, with 1 being associated with a worse outcome and 5 being associated with a better outcome.
Satiety Survey
A 4 question survey, scaled 0 (not at all) to 10 (extremely) designed to assess satiety
Self-Reported Weight
lbs
Adverse Events
Documented changes in health and symptoms through self-report
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
Ferritin
ng/mL. Dried blood from a finger prick collected using at home kit. Used to support exploratory research objectives by complementing participant-reported GI symptoms and behavioral outcomes with biological measures.
Homocysteine
ug/mL. Dried blood from a finger prick collected using at home kit. Used to support exploratory research objectives by complementing participant-reported GI symptoms and behavioral outcomes with biological measures.
Click on the lead sponsor to view all of their trials.
PepsiCo Global R&D
Lead sponsor
Radicle Science Inc.
Collaborator
