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OpenTrials
Completed

NCT Number: NCT03867591

Fermented Soy and Heartburn Symptom Relief

Heartburn is as common gastrointestinal symptom experienced by otherwise healthy adults and typically manifests as a painful burning sensation in the upper abdomen or in the chest. Typically, heartburn symptoms are treated with over-the-counter (OTC) medications which may come with side effects.

There is suggestive evidence of the efficacy of fermented soy (Gastro-AD®) for the heartburn symptom relief. The aim of the study is to evaluate the effect of a fermented soy on heartburn symptom relief and time to onset.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Food Science and Human Nutrition Department

Gainesville, Florida, 32611, United States

About this study

Heartburn is as common gastrointestinal symptom experienced by otherwise healthy adults and typically manifests as a painful burning sensation in the upper abdomen or in the chest. Usually it is caused by the regurgitation of gastric acid into the esophagus. The prevalence of heartburn is 10-20% worldwide and is increasing. Typically, heartburn symptoms are treated with over-the-counter (OTC) medications which may come with side effects.

Gastro-AD® is a commercially available food supplement produced by fermentation of soy by a specific strain of Lactobacillus. There is suggestive evidence, in vivo as well as in vitro studies, of the efficacy of fermented soy (Gastro-AD®) for the heartburn symptom relief. The aim of the study is to evaluate the effect of a fermented soy on heartburn symptom relief and time to onset. It is hypothesized that the consumption of 1-3 g of fermented soy will relieve the heartburn symptom severity.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Able to provide written informed consent in English.
  • Willing to have height and weight measured and provide demographic information (e.g. age, race, sex)
  • Experience heartburn symptoms at least 2 days a week during the past 3 months.
  • Use OTC product(s), supplements, or dietary manipulation to relieve heartburn symptoms in the last 3 months.
  • Willing to take the study soy supplement before resorting to OTC product(s) to control heartburn symptoms.
  • Willing to complete questionnaires, records, and diaries associated with the study and to complete all clinical visits.
  • Willing to provide information about dietary intake; 3-day online 24-hr recalls during baseline, intervention, and washout.
  • Willing and able to provide a valid social security for study payment purposes.

Exclusion criteria

  • Do not meet the above criteria.
  • Soy allergy
  • Severe heartburn problem (cannot be ignored and often limits your concentration on daily activities) during the last week
  • Diagnosed or currently being treated for any gastrointestinal diseases including GERD, gastric ulcers, Crohn's, celiac, ulcerative colitis, etc.
  • Self-disclosed as pregnant or breast-feeding or planning on becoming pregnant during the study duration.
  • Currently participating in another clinical study.

Treatment and study plan

Gastro-AD®

Other

The product under study is Gastro-AD® fermented soy powder in the form of orodispersible flavored powder packed in non-transparent sachets.

Content: 1 g of Gastro-AD® powder per sachet + flavoring agents.

Placebo

Other

The placebo product will have very similar appearance, color, texture and taste as the Gastro-AD® flavored sachet. The placebo sachets contain the respective amount of maltodextrin (1 g) and exactly the same flavoring and coloring agents as Gastro-AD® powder flavored sachets.

Primary outcomes

  1. Change in severity of heartburn symptoms

    Time frame: 5 minutes, 15 minutes, 30 minutes

    Severity on a 5-point Likert scale ranging from 1 = no symptoms to 5 = severe discomfort

Secondary outcomes

  1. Change in Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: Baseline; Week 4; Week 5

    The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.

  2. Change in Quality of Life (GERD-QOL)

    Time frame: Baseline; Week 4; Week 5

    The GERD-QOL is disease-specific instrument of 16 items combined into domains.

  3. Heartburn event frequency

    Time frame: Baseline; Week 4; Week 5

    Heartburn events per period

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Lallemand Bio-Ingredients

Registry information

Official study title

The Effect of Fermented Soy Supplementation on Occasional Heartburn Symptom Relief: A Randomized, Placebo-Controlled, Double-blind Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 8, 2019
Registry last updated
Jun 9, 2020

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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