Study to Evaluate the Efficacy of Poppi Apple Cider Vinegar Prebiotic Soda to Improve Gut Health In Participants

Sponsor
Drink Poppi (Industry)
Overall Status
Completed
CT.gov ID
NCT05418439
Collaborator
Citruslabs (Industry)
38
1
1
30
38.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Drink Poppi Soda
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Study to Evaluate the Efficacy of Poppi Apple Cider Vinegar Prebiotic Soda to Improve Gut Health In Participants
Actual Study Start Date :
Apr 1, 2022
Actual Primary Completion Date :
May 1, 2022
Actual Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Poppi ACV prebiotic soda

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

Dietary Supplement: Drink Poppi Soda
Drink Poppi Vinager Soda

Outcome Measures

Primary Outcome Measures

  1. Change in IBS symptoms [Time Frame: Baseline to 4 weeks) [4 weeks]

    Survey-based assessment (0-5 scale) of changes in IBS symptoms with higher scores representing an improved outcome.

  2. Change in bowel movements [Time Frame: Baseline to 4 weeks) [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.

  3. Change in skin health [Time Frame: Baseline to 4 weeks) [4 weeks]

    Survey-based assessment (0-5 scale) of changes in perceived skin health with higher scores representing an improved outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Citruslabs Santa Monica California United States 90404

Sponsors and Collaborators

  • Drink Poppi
  • Citruslabs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Drink Poppi
ClinicalTrials.gov Identifier:
NCT05418439
Other Study ID Numbers:
  • 20229 Poppi
First Posted:
Jun 14, 2022
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Drink Poppi
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2022