Study to Evaluate the Efficacy of Poppi Apple Cider Vinegar Prebiotic Soda to Improve Gut Health In Participants
Primary Purpose
IBS - Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Drink Poppi Soda
Sponsored by
About this trial
This is an interventional other trial for IBS - Irritable Bowel Syndrome focused on measuring bloating, abdominal pain, gassiness, heartburn
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
Sites / Locations
- Citruslabs
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Poppi ACV prebiotic soda
Arm Description
Each day in the morning, for lunch, or in the afternoon, participants will drink one 12 fl oz. can of Poppi ACV prebiotic soda.
Outcomes
Primary Outcome Measures
Change in IBS symptoms [Time Frame: Baseline to 4 weeks)
Survey-based assessment (0-5 scale) of changes in IBS symptoms with higher scores representing an improved outcome.
Change in bowel movements [Time Frame: Baseline to 4 weeks)
Survey-based assessment (0-5 scale) of changes in stool frequency and consistency (constipation vs. diarrhea vs. normal) with higher scores representing an improved outcome.
Change in skin health [Time Frame: Baseline to 4 weeks)
Survey-based assessment (0-5 scale) of changes in perceived skin health with higher scores representing an improved outcome.
Secondary Outcome Measures
Full Information
NCT ID
NCT05418439
First Posted
June 10, 2022
Last Updated
June 13, 2022
Sponsor
Drink Poppi
Collaborators
Citruslabs
1. Study Identification
Unique Protocol Identification Number
NCT05418439
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drink Poppi
Collaborators
Citruslabs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome
Keywords
bloating, abdominal pain, gassiness, heartburn
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Poppi ACV prebiotic soda
Arm Type
Experimental
Arm Description
Each day in the morning, for lunch, or in the afternoon, participants will drink one 12 fl oz. can of Poppi ACV prebiotic soda.
Intervention Type
Dietary Supplement
Intervention Name(s)
Drink Poppi Soda
Intervention Description
Drink Poppi Vinager Soda
Primary Outcome Measure Information:
Title
Change in IBS symptoms [Time Frame: Baseline to 4 weeks)
Description
Survey-based assessment (0-5 scale) of changes in IBS symptoms with higher scores representing an improved outcome.
Time Frame
4 weeks
Title
Change in bowel movements [Time Frame: Baseline to 4 weeks)
Description
Survey-based assessment (0-5 scale) of changes in stool frequency and consistency (constipation vs. diarrhea vs. normal) with higher scores representing an improved outcome.
Time Frame
4 weeks
Title
Change in skin health [Time Frame: Baseline to 4 weeks)
Description
Survey-based assessment (0-5 scale) of changes in perceived skin health with higher scores representing an improved outcome.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Efficacy of Poppi Apple Cider Vinegar Prebiotic Soda to Improve Gut Health In Participants
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