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

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.

Study Overview

• Status: Completed
• Conditions: IBS - Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Drink Poppi Soda

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks
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.	4 weeks
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.	4 weeks

Collaborators and Investigators

• Sponsor: Drink Poppi
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: heartburn; bloating; abdominal pain; gassiness
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome
• Other Study ID Numbers: 20229 Poppi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No