NCT07563855已完成不适用
An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- PROMIS Constipation 9A
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
GLP-1 Users and Non-users
Experimental
Participants currently taking a GLP-1 for 3 months or longer, or wishing to lose weight, but not currently on a GLP-1
干预措施: A ready-to-mix beverage containing protein, fiber, and electrolytes (Dietary Supplement)
结局指标
主要结局
PROMIS Constipation 9A
时间窗: 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.
次要结局
- Digestion-associated Quality of Life Questionnaire(At baseline and weeks 1-4 of the intervention)
- PROMIS Belly Pain 5A(At baseline and weeks 1-4 of the intervention)
- Satiety Survey(At baseline and weeks 1-4 of the intervention)
- Self-Reported Weight(At baseline and weeks 1-4 of intervention)
- 24 Hour Recall Food Diary(At baseline and upon completion of the 4 week intervention)
研究者
研究点 (2)
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