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Completed

NCT Number: NCT05418439

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.

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Key information

Conditions

IBS - Irritable Bowel Syndrome Abdominal Pain Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Heartburn Intestinal Diseases Irritable Bowel Syndrome Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drink Poppi Soda

Dietary Supplement

Drink Poppi Vinager Soda

Primary outcomes

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

Drink Poppi

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 14, 2022
Registry last updated
Jun 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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