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 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
133
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
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California
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Del Mar, California, Estados Unidos, 90214
- Virtual study. Managed by Radicle Science Inc.
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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
|
Subjects will consume the ready-to-mix beverage ad-libitum over the 4-week study period.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
PROMIS Constipation 9A
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Digestion-associated Quality of Life Questionnaire
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adverse Events
Prazo: 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
Prazo: 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
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At baseline and upon completion of the 4 week intervention
|
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Ferritin
Prazo: 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
Prazo: 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.
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At baseline and upon completion of the 4 week intervention
|
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high-sensitivity C-reactive protein
Prazo: 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
Prazo: 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
Prazo: 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.
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At baseline and upon completion of the 4 week intervention
|
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Cystatin C
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
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Thyroid Stimulating Hormone
Prazo: 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
Prazo: 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
Prazo: 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 - ApoA1 ratio
Prazo: 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
|
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Low Density Lipoprotein
Prazo: 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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High Density Lipoprotein
Prazo: 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
Prazo: 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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Triglycerides
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
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At baseline and upon completion of the 4 week intervention
|
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DHEA-S
Prazo: 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
|
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Testosterone - Cortisol Ratio
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Susan Hewlings, PhD, Radicle Science Inc.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
4 de maio de 2026
Conclusão Primária (Real)
7 de julho de 2026
Conclusão do estudo (Real)
7 de julho de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
16 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de abril de 2026
Primeira postagem (Real)
4 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PEP-2602
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .