An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes
tiistai 25. elokuuta 2026 päivittänyt: PepsiCo Global R&D
The purpose of this study is to:
- 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
- Understand how participants may use and accept a health and wellness product
- Understand the side effects of a health and wellness product
- Evaluate the quality and effects of a health and wellness product on participant health through self-reported measures (electronic surveys) and biomarker collections.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
133
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
California
-
Del Mar, California, Yhdysvallat, 90214
- Virtual study. Managed by Radicle Science Inc.
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Joo
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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
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Subjects will consume the ready-to-mix beverage ad-libitum over the 4-week study period.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
PROMIS Constipation 9A
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Digestion-associated Quality of Life Questionnaire
Aikaikkuna: 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
|
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PROMIS Belly Pain 5A
Aikaikkuna: 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
Aikaikkuna: 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
|
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Self-Reported Weight
Aikaikkuna: At baseline and weeks 1-4 of intervention
|
lbs
|
At baseline and weeks 1-4 of intervention
|
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24 Hour Recall Food Diary
Aikaikkuna: At baseline and upon completion of the 4 week intervention
|
ASA24
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At baseline and upon completion of the 4 week intervention
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Adverse Events
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
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Homocysteine
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
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Hemoglobin A1C
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
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Total Cholesterol-High Density Lipoprotein Ratio
Aikaikkuna: 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
Aikaikkuna: 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
|
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Cortisol
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
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At baseline and upon completion of the 4 week intervention
|
|
Estradiol
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Susan Hewlings, PhD, Radicle Science Inc.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
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Keskiviikko 29. huhtikuuta 2026
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Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .