None listed
Conditions
Interventions
Others(Placebo-Controlled Trial) : Active Comparator : A2 Milk, 275 mL, twice daily after meal (550 mL/day)
Placebo Comparator : A1/A2 milk, 275 mL, twice daily after meal (550 mL/day)
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Between 19 to 65 years of age 2. Participants who are experiencing digestive symptoms abdominal bloating, abdominal pain, borborygmus, fecal urgency, flatulence, diarrhea, nausea) following milk consumption on Visit 1 with a total score on the digestive discomfort symptom survey being 7 point or more for the following 5 items: abdominal pain, borborygmus, flatulence, diarrhea, nausea (Individuals who have indicated scored 7 or more on any one item in the 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, biliary, renal, urinary, neurological, endocrine, 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) History of bowel obstruction 4) Hospitalized within the last 3 months of Visit 1 5) Has taken the following drugs or foods within 3 months of visit 1 ? Drugs that affect body weight {obesity drugs (appetite suppressants, fat absorption inhibitors, Glucagon like peptide 1 (GLP 1) recept or agonists etc.) etc.), diabetes drugs, etc.} ? Psychiatric drugs such as antidepressants and antipsychotics ? Diuretics ? Systemic steroid preparations and hormonal preparations (including oral contraceptives and thyroid hormone preparations 6) Has taken immunosuppressive drugs or anti inflammatory drugs within the last month (30 days) of Visit 1 7) Administered systemic antibiotics, systemic antibacterial agents, colonics, bowel cleansers, probiotics, prebiotics, antioxidant related heal th functional foods (Coenzyme Q10, red ginseng, etc.), and glutathione containing products within 2 weeks of visit 1 (however, vitamin preparations can be used together if taken without changing dosage or medication for more than 3 months 8) Has taken prokinetics (Serotonin type 4 (5-HT4) Agonist, D2 Antagonists, Cholinergic Agonists etc.), laxatives {fiber supplements (Psyllium, Methylce llulose etc.), stool softeners, osmotic laxatives (Sorbitol, Lactulose etc.), stimulant laxatives (Bisacodyl , Anthraquinone etc.)} within 1 week of visit 1 9) History of alcohol abuse or who chronically consume alcohol* * Drinking alcohol equivalent to an average of 40 g or more per day (280 g/week) for men and more than 20 g of alcohol per day (140 g/week) for women. 10) Pregnant, breastfeeding, or planning to become pregnant during the study period 11) 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 12) Allergic to dairy products ( bloody stool, muscle/joint pain, headache, dizziness, coma, short term memory impairment, oral ulcer, cardiac arrhythmia, sore t hroat, increased frequency of urination, acne, depression) 13) 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 |
|---|---|
| Digestive Discomfort Symptom Survey;Visual analogue scale Irritable Bowel Syndrome ( VAS IBS);Blood Marker: Glutathione (GSH);Blood Marker: 8-Oxo-2'-deoxyguanosine (8-OxodG);Blood Marker: 5-hydroxymethyl-deoxyuridine (5-OHmdU);Blood Marker: High Sensitive C-reactive protein (hs-CRP);Blood marker: Interleukin-4 (IL-4);Blood marker: Interleukin-4 (IL-6);Blood marker: Tumor necrosis factor-a (TNF-a);Blood marker: Dipeptidyl Peptidase-4 (DPP-IV);Blood marker: ß-casomorphin-7 (BCM-7);Blood marker: ß-casomorphin-10 (BCM-10);Stool marker: Short chain Fatty Acid (SCFA);Stool marker: Calprotectin;Stool marker: Microbiome;Bowel Frequency and Form | — |
Countries
Korea, Republic of
Contacts
Public ContactNayoung Kim
Seoul National University Bundang Hospital
Outcome results
None listed