KCT0009301Active, not recruitingUnknown
A 8 week, Randomized, Double-Blind, Crossover, Placebo-Controlled Trial for the Evaluation of the Efficacy and Safety of A2 Milk on Digestion
Seoul Dairy co-op.0 sites40 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20(Year) to 70(Year) (—)
- Sex
- All
Inclusion Criteria
- •1) Between 20 to 70 years of age
- •2) Participants who are experiencing digestive symptoms (bloating, gas, heaviness, abdominal pain, flatulence, borborygmus, 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.)
- •3) Those who have agreed to participate and given written consent through the Informed Consent Form prior to the study
Exclusion Criteria
- •1) Currently undergoing treatment for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary, renal and urinary, neurological, musculoskeletal, mental, infectious, metabolic diseases, and malignancies
- •2) Diagnosed with or has a history of gastrointestinal diseases (irritable bowel syndrome, colitis, ulcerative colitis, abdominal diseases etc.), or has undergone gastrointestinal surgery
- •3) Individuals with severe lactose intolerance
- •4) History of bowel obstruction
- •5) Alcohol addiction or substance abuse
- •6) Hospitalized within the last 3 months of Visit 1
- •7) 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
- •8) Has taken immunosuppressive drugs or anti-inflammatory drugs within the last month (30 days) of Visit 1
- •9) Administered antibiotics or laxatives within the last 2 weeks of Visit 2
- •10) Has taken prokinetics (Serotonin type 4 (5-HT4) Agonist, D2 Antagonists, Cholinergic Agonists etc.), laxatives {fiber supplements (Psyllium, Methylcellulose etc.), stool softeners, osmotic laxatives (Sorbitol, Lactulose etc.), stimulant laxatives (Bisacodyl, Anthraquinone etc.)}
- •11) Pregnant, breastfeeding, or planning to become pregnant during the study period
- •12) Allergic to dairy products
- •13) Participated in another interventional clinical trial (including human trials) within the last 3 months of Visit 1, or planning to participate in another interventional clinical trial (including human trials) after the start of this study
- •14) Individuals deemed inappropriate for the study by the investigator
Investigators
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