An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes
25 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
133
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
California
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Del Mar, California, Estados Unidos, 90214
- Virtual study. Managed by Radicle Science Inc.
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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
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Subjects will consume the ready-to-mix beverage ad-libitum over the 4-week study period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PROMIS Constipation 9A
Periodo de tiempo: 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.
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At baseline and weeks 1-4 of the intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Digestion-associated Quality of Life Questionnaire
Periodo de tiempo: 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
Periodo de tiempo: At baseline and weeks 1-4 of the intervention
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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
Periodo de tiempo: At baseline and weeks 1-4 of the intervention
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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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adverse Events
Periodo de tiempo: From enrollment through completion of the study, average 5 weeks.
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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
Periodo de tiempo: At baseline and upon completion of the 4 week intervention
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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
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At baseline and upon completion of the 4 week intervention
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Ferritin
Periodo de tiempo: 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.
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At baseline and upon completion of the 4 week intervention
|
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Homocysteine
Periodo de tiempo: At baseline and upon completion of the 4 week intervention
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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.
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At baseline and upon completion of the 4 week intervention
|
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high-sensitivity C-reactive protein
Periodo de tiempo: At baseline and upon completion of the 4 week intervention
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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
Periodo de tiempo: 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.
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At baseline and upon completion of the 4 week intervention
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Hemoglobin A1C
Periodo de tiempo: At baseline and upon completion of the 4 week intervention
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%. 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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Cystatin C
Periodo de tiempo: At baseline and upon completion of the 4 week intervention
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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
Periodo de tiempo: At baseline and upon completion of the 4 week intervention
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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.
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At baseline and upon completion of the 4 week intervention
|
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Total Cholesterol-High Density Lipoprotein Ratio
Periodo de tiempo: At baseline and upon completion of the 4 week intervention
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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.
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At baseline and upon completion of the 4 week intervention
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Triglyceride - High Density Lipoprotein Ratio
Periodo de tiempo: At baseline and upon completion of the 4 week intervention
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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.
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At baseline and upon completion of the 4 week intervention
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Cortisol
Periodo de tiempo: 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.
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At baseline and upon completion of the 4 week intervention
|
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Thyroid Stimulating Hormone
Periodo de tiempo: 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.
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At baseline and upon completion of the 4 week intervention
|
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ApoA1
Periodo de tiempo: 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.
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At baseline and upon completion of the 4 week intervention
|
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ApoB
Periodo de tiempo: 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.
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At baseline and upon completion of the 4 week intervention
|
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ApoB - ApoA1 ratio
Periodo de tiempo: 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.
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At baseline and upon completion of the 4 week intervention
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Low Density Lipoprotein
Periodo de tiempo: At baseline and upon completion of the 4 week intervention
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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.
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At baseline and upon completion of the 4 week intervention
|
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High Density Lipoprotein
Periodo de tiempo: 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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Total Cholesterol
Periodo de tiempo: 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.
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At baseline and upon completion of the 4 week intervention
|
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Triglycerides
Periodo de tiempo: 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
Periodo de tiempo: 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.
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At baseline and upon completion of the 4 week intervention
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Follicle Stimulating Hormone
Periodo de tiempo: 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.
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At baseline and upon completion of the 4 week intervention
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Testosterone
Periodo de tiempo: At baseline and upon completion of the 4 week intervention
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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.
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At baseline and upon completion of the 4 week intervention
|
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DHEA-S
Periodo de tiempo: 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.
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At baseline and upon completion of the 4 week intervention
|
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Testosterone - Cortisol Ratio
Periodo de tiempo: At baseline and upon completion of the 4 week intervention
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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.
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At baseline and upon completion of the 4 week intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Susan Hewlings, PhD, Radicle Science Inc.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
4 de mayo de 2026
Finalización primaria (Actual)
7 de julio de 2026
Finalización del estudio (Actual)
7 de julio de 2026
Fechas de registro del estudio
Enviado por primera vez
16 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2026
Publicado por primera vez (Actual)
4 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PEP-2602
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .