Health, Quality of Life, Wellness
Conditions
Keywords
product, beverage, protein, fiber, electrolytes, hydration, satiety, digestion, gastrointestinal, constipation, belly pain, GLP-1, weight, attitudes, behaviors
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTA 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.
Sponsors
PepsiCo Global R&D
Radicle Science Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Constipation 9A | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Digestion-associated Quality of Life Questionnaire | 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. |
| PROMIS Belly Pain 5A | 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. |
| Satiety Survey | 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 |
| Self-Reported Weight | At baseline and weeks 1-4 of intervention | lbs |
| 24 Hour Recall Food Diary | At baseline and upon completion of the 4 week intervention | ASA24 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSusan Hewlings, PhD
Radicle Science Inc.
Outcome results
None listed