Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07563855

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Health Behavior Body Weight Constipation Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Signs and Symptoms, Digestive Wellness

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virtual study. Managed by Radicle Science Inc.

Del Mar, California, 90214, United States

Location status: Recruiting

Location contact

Radicle Science Inc.

CONTACT

[email protected]

760-281-3898

Susan Hewlings, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. PROMIS Constipation 9A

    Time frame: At baseline and weeks 1-4 of the intervention

    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.

Secondary outcomes

  1. Digestion-associated Quality of Life Questionnaire

    Time frame: At baseline and weeks 1-4 of the intervention

    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.

  2. PROMIS Belly Pain 5A

    Time frame: At baseline and weeks 1-4 of the intervention

    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.

  3. Satiety Survey

    Time frame: At baseline and weeks 1-4 of the intervention

    A 4 question survey, scaled 0 (not at all) to 10 (extremely) designed to assess satiety

  4. Self-Reported Weight

    Time frame: At baseline and weeks 1-4 of intervention

    lbs

  5. 24 Hour Recall Food Diary

    Time frame: At baseline and upon completion of the 4 week intervention

    ASA24

Other outcomes

  1. Adverse Events

    Time frame: From enrollment through completion of the study, average 5 weeks.

    Documented changes in health and symptoms through self-report

  2. Evaluation of an at-home Tiny Health Stool kit

    Time frame: At baseline and upon completion of the 4 week intervention

    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

  3. Ferritin

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  4. Homocysteine

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  5. high-sensitivity C-reactive protein

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  6. Vitamin D

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  7. Hemoglobin A1C

    Time frame: At baseline and upon completion of the 4 week intervention

    %. 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.

  8. Cystatin C

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  9. Fasting insulin

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  10. Total Cholesterol-High Density Lipoprotein Ratio

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  11. Triglyceride - High Density Lipoprotein Ratio

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  12. Cortisol

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  13. Thyroid Stimulating Hormone

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  14. ApoA1

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  15. ApoB

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  16. ApoB - ApoA1 ratio

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  17. Low Density Lipoprotein

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  18. High Density Lipoprotein

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  19. Total Cholesterol

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  20. Triglycerides

    Time frame: At baseline and upon completion of the 4 week intervention

    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

  21. Estradiol

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  22. Follicle Stimulating Hormone

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  23. Testosterone

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  24. DHEA-S

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

  25. Testosterone - Cortisol Ratio

    Time frame: At baseline and upon completion of the 4 week intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Susan Hewings, PhD

CONTACT

[email protected]

760-281-3898

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Collaborators

  • Radicle Science Inc.

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.