An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes
25. srpna 2026 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Intervenční
Zápis (Aktuální)
133
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
California
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Del Mar, California, Spojené státy, 90214
- Virtual study. Managed by Radicle Science Inc.
-
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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
|
Subjects will consume the ready-to-mix beverage ad-libitum over the 4-week study period.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
PROMIS Constipation 9A
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Digestion-associated Quality of Life Questionnaire
Časové okno: 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.
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At baseline and weeks 1-4 of the intervention
|
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PROMIS Belly Pain 5A
Časové okno: 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.
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At baseline and weeks 1-4 of the intervention
|
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Satiety Survey
Časové okno: 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
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At baseline and weeks 1-4 of the intervention
|
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Self-Reported Weight
Časové okno: At baseline and weeks 1-4 of intervention
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lbs
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At baseline and weeks 1-4 of intervention
|
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24 Hour Recall Food Diary
Časové okno: At baseline and upon completion of the 4 week intervention
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ASA24
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At baseline and upon completion of the 4 week intervention
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Adverse Events
Časové okno: From enrollment through completion of the study, average 5 weeks.
|
Documented changes in health and symptoms through self-report
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From enrollment through completion of the study, average 5 weeks.
|
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Evaluation of an at-home Tiny Health Stool kit
Časové okno: 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
|
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Ferritin
Časové okno: 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
Časové okno: 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
|
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high-sensitivity C-reactive protein
Časové okno: 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.
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At baseline and upon completion of the 4 week intervention
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Vitamin D
Časové okno: 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
Časové okno: 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
|
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Cystatin C
Časové okno: 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.
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At baseline and upon completion of the 4 week intervention
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Fasting insulin
Časové okno: 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
Časové okno: 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
|
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Triglyceride - High Density Lipoprotein Ratio
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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ApoA1
Časové okno: 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
|
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ApoB
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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Estradiol
Časové okno: 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
|
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Follicle Stimulating Hormone
Časové okno: 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
|
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Testosterone
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Susan Hewlings, PhD, Radicle Science Inc.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
4. května 2026
Primární dokončení (Aktuální)
7. července 2026
Dokončení studie (Aktuální)
7. července 2026
Termíny zápisu do studia
První předloženo
16. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
29. dubna 2026
První zveřejněno (Aktuální)
4. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
27. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
25. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Klíčová slova
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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .