An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes

Обзор

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.

Вмешательства

• Пищевая 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.

Первичные конечные точки

• PROMIS Constipation 9A [Срок оценки: At baseline and weeks 1-4 of the intervention]

Вторичные конечные точки (5)

• Digestion-associated Quality of Life Questionnaire [Срок оценки: At baseline and weeks 1-4 of the intervention]
• PROMIS Belly Pain 5A [Срок оценки: At baseline and weeks 1-4 of the intervention]
• Satiety Survey [Срок оценки: At baseline and weeks 1-4 of the intervention]
• Self-Reported Weight [Срок оценки: At baseline and weeks 1-4 of intervention]
• 24 Hour Recall Food Diary [Срок оценки: At baseline and upon completion of the 4 week intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Virtual study. Managed by Radicle Science Inc. — Del Mar

Идентификаторы

NCT: NCT07563855 · PEP-2602

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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