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

25 augustus 2026 bijgewerkt door: PepsiCo Global R&D

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

133

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • Del Mar, California, Verenigde Staten, 90214
        • Virtual study. Managed by Radicle Science Inc.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Voedingssupplement: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
PROMIS Constipation 9A
Tijdsspanne: 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.
At baseline and weeks 1-4 of the intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Digestion-associated Quality of Life Questionnaire
Tijdsspanne: 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.
At baseline and weeks 1-4 of the intervention
PROMIS Belly Pain 5A
Tijdsspanne: 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.
At baseline and weeks 1-4 of the intervention
Satiety Survey
Tijdsspanne: 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
At baseline and weeks 1-4 of the intervention
Self-Reported Weight
Tijdsspanne: At baseline and weeks 1-4 of intervention
lbs
At baseline and weeks 1-4 of intervention
24 Hour Recall Food Diary
Tijdsspanne: At baseline and upon completion of the 4 week intervention
ASA24
At baseline and upon completion of the 4 week intervention

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adverse Events
Tijdsspanne: From enrollment through completion of the study, average 5 weeks.
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
Tijdsspanne: 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
At baseline and upon completion of the 4 week intervention
Ferritin
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
Homocysteine
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
high-sensitivity C-reactive protein
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
Vitamin D
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
Hemoglobin A1C
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
Cystatin C
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
Fasting insulin
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
Total Cholesterol-High Density Lipoprotein Ratio
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
Triglyceride - High Density Lipoprotein Ratio
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
Cortisol
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
Thyroid Stimulating Hormone
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
ApoA1
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
ApoB
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
ApoB - ApoA1 ratio
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
Low Density Lipoprotein
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
High Density Lipoprotein
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
Total Cholesterol
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
Triglycerides
Tijdsspanne: 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
At baseline and upon completion of the 4 week intervention
Estradiol
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
Follicle Stimulating Hormone
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
Testosterone
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
DHEA-S
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention
Testosterone - Cortisol Ratio
Tijdsspanne: 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.
At baseline and upon completion of the 4 week intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

PepsiCo Global R&D

Medewerkers

Radicle Science Inc.

Onderzoekers

  • Hoofdonderzoeker: Susan Hewlings, PhD, Radicle Science Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

4 mei 2026

Primaire voltooiing (Werkelijk)

7 juli 2026

Studie voltooiing (Werkelijk)

7 juli 2026

Studieregistratiedata

Eerst ingediend

16 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 april 2026

Eerst geplaatst (Werkelijk)

4 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

25 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PEP-2602

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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