NCT05418439

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

June 10, 2022

Last Update Submit

June 13, 2022

Conditions

Keywords

bloatingabdominal paingassinessheartburn

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Poppi ACV prebiotic soda

EXPERIMENTAL

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

Interventions

Drink Poppi SodaDIETARY_SUPPLEMENT

Drink Poppi Vinager Soda

Poppi ACV prebiotic soda

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeAbdominal PainHeartburn

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2022

First Posted

June 14, 2022

Study Start

April 1, 2022

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

June 15, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations