An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Wellness; Health
• Intervention / Treatment: Dietary supplement: A ready-to-mix beverage containing protein, fiber, and electrolytes

• Study Type: Interventional
• Enrollment (Estimated): 133
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Hewings, PhD; Phone Number: 760-281-3898; Email: help@radiclescience.com

Study Locations

• United States
  • California
    • Del Mar, California, United States, 90214
      • Recruiting
      • Virtual study. Managed by Radicle Science Inc.
      • Contact: Radicle Science Inc.; Phone Number: 760-281-3898; Email: help@radiclescience.com
      • Principal Investigator: Susan Hewlings, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GLP-1 Users and Non-users; 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; Subjects will consume the ready-to-mix beverage ad-libitum over the 4-week study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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
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.	At baseline and weeks 1-4 of the intervention
Satiety Survey	A 4 question survey, scaled 0 (not at all) to 10 (extremely) designed to assess satiety	At baseline and weeks 1-4 of the intervention
Self-Reported Weight	lbs	At baseline and weeks 1-4 of intervention
24 Hour Recall Food Diary	ASA24	At baseline and upon completion of the 4 week intervention

Other Outcome Measures

Outcome Measure	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	At baseline and upon completion of the 4 week intervention
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.	At baseline and upon completion of the 4 week intervention
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.	At baseline and upon completion of the 4 week intervention
high-sensitivity C-reactive protein	mg/L. 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.	At baseline and upon completion of the 4 week intervention
Vitamin D	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.	At baseline and upon completion of the 4 week intervention
Hemoglobin A1C	%. 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.	At baseline and upon completion of the 4 week intervention
Cystatin C	mg/LL. 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.	At baseline and upon completion of the 4 week intervention
Fasting insulin	uIU/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.	At baseline and upon completion of the 4 week intervention
Total Cholesterol-High Density Lipoprotein Ratio	mg/dL ratio, with lower numbers associated with lower cardiovascular risk. 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.	At baseline and upon completion of the 4 week intervention
Triglyceride - High Density Lipoprotein Ratio	mg/dL ratio, high numbers are associated with increased cardiovascular risk. 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.	At baseline and upon completion of the 4 week intervention
Cortisol	ug/dL. 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.	At baseline and upon completion of the 4 week intervention
Thyroid Stimulating Hormone	mu/L. 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.	At baseline and upon completion of the 4 week intervention
ApoA1	mg/dL. 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.	At baseline and upon completion of the 4 week intervention
ApoB	mg/dL. 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.	At baseline and upon completion of the 4 week intervention
ApoB - ApoA1 ratio	mg/dL ratio, higher numbers associated with increased cardiovascular risk. 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.	At baseline and upon completion of the 4 week intervention
Low Density Lipoprotein	mg/dL. 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.	At baseline and upon completion of the 4 week intervention
High Density Lipoprotein	mg/dL. 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.	At baseline and upon completion of the 4 week intervention
Total Cholesterol	mg/dL. 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.	At baseline and upon completion of the 4 week intervention
Triglycerides	Dried blood from a finger prick. Used to support exploratory research objectives by complementing participant-reported GI symptoms and behavioral outcomes with biological measures. Tests levels of Ferritin, Homocysteine, Hs-CRP, Vitamin D, HbA1c, Cystatin C or Fasting Insulin, TC:HDL ratio, TG:HDL ratio, Cortisol, TSH, ApoA1, ApoB, ApoB:ApoA1 ratio, LDL, HDL, Total cholesterol, Triglycerides, Estradiol, FSH, Testosterone, DHEA-S, and Testosterone:cortisol ratio	At baseline and upon completion of the 4 week intervention
Estradiol	pg/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.	At baseline and upon completion of the 4 week intervention
Follicle Stimulating Hormone	IU/L. 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.	At baseline and upon completion of the 4 week intervention
Testosterone	ng/dL. 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.	At baseline and upon completion of the 4 week intervention
DHEA-S	ug/dL. 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.	At baseline and upon completion of the 4 week intervention
Testosterone - Cortisol Ratio	Ratio to measure of the balance between anabolic and catabolic processes in the body. 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.	At baseline and upon completion of the 4 week intervention

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Collaborators: Radicle Science Inc.
• Investigators: Principal Investigator: Susan Hewlings, PhD, Radicle Science Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: GLP-1; satiety; constipation; protein; gastrointestinal; weight; beverage; fiber; attitudes; digestion; electrolytes; hydration; behaviors; product; belly pain
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Body Weight; Constipation; Behavior; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Carbohydrates; Carbohydrates; Inorganic Chemicals; Dietary Fiber; Electrolytes
• Other Study ID Numbers: PEP-2602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No