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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 августа 2026 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

133

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Да

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Другой
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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
Диетическая добавка: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
PROMIS Constipation 9A
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Digestion-associated Quality of Life Questionnaire
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: At baseline and weeks 1-4 of intervention
lbs
At baseline and weeks 1-4 of intervention
24 Hour Recall Food Diary
Временное ограничение: At baseline and upon completion of the 4 week intervention
ASA24
At baseline and upon completion of the 4 week intervention

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Adverse Events
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

PepsiCo Global R&D

Соавторы

Radicle Science Inc.

Следователи

  • Главный следователь: Susan Hewlings, PhD, Radicle Science Inc.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

4 мая 2026 г.

Первичное завершение (Действительный)

7 июля 2026 г.

Завершение исследования (Действительный)

7 июля 2026 г.

Даты регистрации исследования

Первый отправленный

16 апреля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

29 апреля 2026 г.

Первый опубликованный (Действительный)

4 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

27 августа 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

25 августа 2026 г.

Последняя проверка

1 августа 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • PEP-2602

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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