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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

2026年8月25日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

133

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • California
      • Del Mar、California、アメリカ、90214
        • Virtual study. Managed by Radicle Science Inc.

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：他の
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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
ダイエットサプリメント：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
PROMIS Constipation 9A
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Digestion-associated Quality of Life Questionnaire
時間枠：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
時間枠：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
時間枠：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
時間枠：At baseline and weeks 1-4 of intervention
lbs
At baseline and weeks 1-4 of intervention
24 Hour Recall Food Diary
時間枠：At baseline and upon completion of the 4 week intervention
ASA24
At baseline and upon completion of the 4 week intervention

その他の成果指標

結果測定
メジャーの説明
時間枠
Adverse Events
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

PepsiCo Global R&D

協力者

Radicle Science Inc.

捜査官

  • 主任研究者：Susan Hewlings, PhD、Radicle Science Inc.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月4日

一次修了 (実際)

2026年7月7日

研究の完了 (実際)

2026年7月7日

試験登録日

最初に提出

2026年4月16日

QC基準を満たした最初の提出物

2026年4月29日

最初の投稿 (実際)

2026年5月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月27日

QC基準を満たした最後の更新が送信されました

2026年8月25日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • PEP-2602

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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