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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 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

133

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • California
      • Del Mar, California, Stany Zjednoczone, 90214
        • Virtual study. Managed by Radicle Science Inc.

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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
Suplement diety: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
PROMIS Constipation 9A
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Digestion-associated Quality of Life Questionnaire
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: At baseline and weeks 1-4 of intervention
lbs
At baseline and weeks 1-4 of intervention
24 Hour Recall Food Diary
Ramy czasowe: At baseline and upon completion of the 4 week intervention
ASA24
At baseline and upon completion of the 4 week intervention

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Adverse Events
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

PepsiCo Global R&D

Współpracownicy

Radicle Science Inc.

Śledczy

  • Główny śledczy: Susan Hewlings, PhD, Radicle Science Inc.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

4 maja 2026

Zakończenie podstawowe (Rzeczywisty)

7 lipca 2026

Ukończenie studiów (Rzeczywisty)

7 lipca 2026

Daty rejestracji na studia

Pierwszy przesłany

16 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

4 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

27 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • PEP-2602

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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