Clinical trial NCT03867591: Fermented Soy and Heartburn Symptom Relief
Official title: The Effect of Fermented Soy Supplementation on Occasional Heartburn Symptom Relief: A Randomized, Placebo-Controlled, Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heartburn
Acid Regurgitation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Lallemand Bio-Ingredients
First posted: 2019-03-08
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in severity of heartburn symptoms
timeFrame: 5 minutes, 15 minutes, 30 minutes
Secondary outcomes:
measure: Change in Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Baseline; Week 4; Week 5
measure: Change in Quality of Life (GERD-QOL)
timeFrame: Baseline; Week 4; Week 5
measure: Heartburn event frequency
timeFrame: Baseline; Week 4; Week 5
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Food Science and Human Nutrition Department
state: Florida
Study officials:
affiliation: University of Florida
name: Wendy J Dahl, PhD
role: PRINCIPAL_INVESTIGATOR
References: