Clinical trial NCT05418439: Study to Evaluate the Efficacy of Poppi Apple Cider Vinegar Prebiotic Soda to Improve Gut Health In Participants
Official title: Study to Evaluate the Efficacy of Poppi Apple Cider Vinegar Prebiotic Soda to Improve Gut Health In Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Keywords: bloating
abdominal pain
gassiness
heartburn
Lead sponsor: Drink Poppi
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2022-06-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This exploratory observational trial provides the opportunity to gather information on the effect of daily consumption of Poppi Apple Cider Vinegar Prebiotic Soda on gut health and digestion.

Detailed description: Individuals aged 18+ with a BMI under 30 and self-reported regular issues with IBS and/or poor digestion symptoms, including bloating, gassiness, heartburn, abdominal pain, constipation or associated symptoms (self-reported), but otherwise healthy will be chosen to participate in the study (see "4. Participant Definition"). Participants will be advised to discontinue any other oral supplement targeting the gut, including antibiotics, during the study and at least 3 months prior to.

Participants will be asked to complete the baseline survey on gut and skin health before the study starts.

Participants will also be asked to discontinue any additional soda consumption during the study.

Each day in the morning, for lunch, or in the afternoon, participants will drink one 12 fl oz. can of Poppi ACV prebiotic soda.

After 2 full weeks (day 14 of the study period) of drinking Poppi daily, participants will complete the 2-week follow up survey of gut and skin health.

After four weeks (day 28) of the study period, participants will complete the 4-week end-of-study follow up survey of gut and skin health. Making the whole study period four weeks.

The gut health surveys completed at baseline, week two and week four will be evaluated to determine the impact of Poppi ACV prebiotic soda on symptoms of poor gut health/digestion/IBS, including bloating, gas, heartburn, constipation and abdominal pain, as well as skin health.

Eligibility criteria: Inclusion Criteria:

* Age: 18-45
* Male or Female
* Must be in generally good health
* BMI under 35
* Self-reported issues with gas, bloating, heartburn/acid reflux, abdominal pain or digestion
* Willing to maintain their standard dietary pattern, activity level and body weight for the duration of the study

Exclusion Criteria:

* Severe chronic conditions, including oncological conditions or psychiatric disease
* Currently pregnant, wanting to become pregnant, or breastfeeding for the duration of the study
* Taking any prescription medication targeting the gut
* Taking any supplements targeting the gut in the past month
* Use of antibiotics in the past 3 months

Primary outcomes:
measure: Change in IBS symptoms [Time Frame: Baseline to 4 weeks)
timeFrame: 4 weeks
measure: Change in bowel movements [Time Frame: Baseline to 4 weeks)
timeFrame: 4 weeks
measure: Change in skin health [Time Frame: Baseline to 4 weeks)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: