An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes
2026년 8월 25일 업데이트: 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.
연구 개요
상태
완전한
연구 유형
중재적
등록 (실제)
133
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Del Mar, California, 미국, 90214
- Virtual study. Managed by Radicle Science Inc.
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PROMIS Constipation 9A
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Digestion-associated Quality of Life Questionnaire
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adverse Events
기간: 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
기간: 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
기간: At baseline and upon completion of the 4 week intervention
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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
기간: 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
기간: 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
|
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Vitamin D
기간: 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
기간: 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
기간: 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
기간: 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.
|
At baseline and upon completion of the 4 week intervention
|
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Total Cholesterol-High Density Lipoprotein Ratio
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Susan Hewlings, PhD, Radicle Science Inc.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 4일
기본 완료 (실제)
2026년 7월 7일
연구 완료 (실제)
2026년 7월 7일
연구 등록 날짜
최초 제출
2026년 4월 16일
QC 기준을 충족하는 최초 제출
2026년 4월 29일
처음 게시됨 (실제)
2026년 5월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 25일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PEP-2602
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .