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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. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

133

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • California
      • Del Mar, California, Vereinigte Staaten, 90214
        • Virtual study. Managed by Radicle Science Inc.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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
Nahrungsergänzungsmittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PROMIS Constipation 9A
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Digestion-associated Quality of Life Questionnaire
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: At baseline and weeks 1-4 of intervention
lbs
At baseline and weeks 1-4 of intervention
24 Hour Recall Food Diary
Zeitfenster: At baseline and upon completion of the 4 week intervention
ASA24
At baseline and upon completion of the 4 week intervention

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Adverse Events
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

PepsiCo Global R&D

Mitarbeiter

Radicle Science Inc.

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

4. Mai 2026

Primärer Abschluss (Tatsächlich)

7. Juli 2026

Studienabschluss (Tatsächlich)

7. Juli 2026

Studienanmeldedaten

Zuerst eingereicht

16. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. April 2026

Zuerst gepostet (Tatsächlich)

4. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

27. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PEP-2602

Plan für individuelle Teilnehmerdaten (IPD)

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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