None listed
Conditions
Interventions
Others(Placebo-Controlled Trial) : Active Comparator: A2 Milk twice daily after meal, 275 mL per time(550 mL/day as A2 milk)
Placebo Comparator: A1/A2 Milk twice daily after meal, 275 mL per time(550
Sponsors
Seoul Dairy co-op.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointestinal Symptom Rating Scale (GSRS) Total Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Upper Abdominal GSRS Score;Lower Abdominal GSRS Score;Digestive Discomfort Symptom Survey;Bowel Frequency and Form;Blood Markers (hs-CRP, IL-4, IgG, IgG1 IgE, BCM-7);Stool Markers (Microbiome, SCFA, Calprotectin) | — |
Countries
Korea, Republic of
Contacts
Public ContactNayoung Kim
Seoul National University Bundang Hospital
Outcome results
None listed