Food Science and Human Nutrition Department
Gainesville, Florida, 32611, United States
NCT Number: NCT03867591
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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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Gainesville, Florida, 32611, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 5 minutes, 15 minutes, 30 minutes
Severity on a 5-point Likert scale ranging from 1 = no symptoms to 5 = severe discomfort
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.
Time frame: Baseline; Week 4; Week 5
The GERD-QOL is disease-specific instrument of 16 items combined into domains.
Time frame: Baseline; Week 4; Week 5
Heartburn events per period
University of Florida
Other
The Effect of Fermented Soy Supplementation on Occasional Heartburn Symptom Relief: A Randomized, Placebo-Controlled, Double-blind Trial
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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