Active — Not RecruitingNot Applicable

Evaluation of the Efficacy and Safety of A2 Milk on Digestion

South Korea40 participantsStarted 2023-04-07

Plain-language summary

The aim of this study is to evaluate the efficacy and safety of A2 milk versus a control (A1/A2 milk) in individuals with digestive discomfort following milk consumption.

Who can participate

Age range20 Years – 70 Years

SexALL

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Inclusion criteria

✓. Between 20 to 70 years of age
✓. Participants who are experiencing digestive symptoms (bloating, gas, heaviness, abdominal pain, gurgling stomach, belching, bowel urgency) following milk consumption on Visit 1 with each score on the digestive discomfort symptom survey being 2 points or less. (Individuals who have indicated 0 in all symptoms or 3 in at least one symptom will be excluded.)
✓. Those who have agreed to participate and given written consent through the Informed Consent Form prior to the study

Exclusion criteria

✕. Currently undergoing treatment for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary, renal and urinary, neurological, musculoskeletal, mental, infectious, metabolic diseases, and malignancies
✕. Diagnosed with or has a history of gastrointestinal diseases (irritable bowel syndrome, colitis, ulcerative colitis, abdominal diseases etc.), or has undergone gastrointestinal surgery
✕. Individuals with severe lactose intolerance
✕. History of bowel obstruction
✕. Alcohol addiction or substance abuse
✕. Hospitalized within the last 3 months of Visit 1
✕. Has taken medication affecting body weight {anti-obesity drugs (appetite suppressants, fat absorption inhibitors, Glucagon-like peptide-1 (GLP-1) receptor agonists etc.), psychiatric drugs such as antidepressants and antipsychotics, diuretics, contraceptives, steroids, female hormones, thyroid hormones} within the last 3 months of Visit 1
✕. Has taken immunosuppressive drugs or anti-inflammatory drugs within the last month (30 days) of Visit 1

What they're measuring

Gastrointestinal Symptom Rating Scale (GSRS) Total Score

Timeframe: Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)

Trial details

NCT IDNCT06252636

SponsorSeoul National University Bundang Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-20

View on ClinicalTrials.gov More Digestive Discomfort trials