A Study on the Effects of A2 Milk on Gut Beneficial Bacteria Growth and Digestion Improvement

NCT06870097 | Active Not Recruiting

• 1 other identifier: B-2412-943-002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effects of A2 milk on gut beneficial bacteria growth, antioxidant activity , digestion, and inflammation improvement

Conditions

Digestive Discomfort

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal Symptom Rating Scale (GSRS) Total Score

  Evaluated through the Gastrointestinal Symptom Rating Scale (GSRS) which uses a 7 point Likert type scale from 1 (no symptoms or normal) to 7(severe symptoms) to rate 15 symptom items including both upper and lower abdominal symptoms. Participants will be given the GSRS to complete.

  Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)

Secondary Outcomes (16)

• Digestive Discomfort Symptom Survey

  Surveys given on Screening(week -2), Visit 3(week 2) to recorded once a day; Retrieved on Visit 2(week 0), Visit 4(week 4) to recorded twice a day within 30 minutes to 3 hours after consuming the test food;

• Visual analogue scale Irritable Bowel Syndrome (VAS-IBS)

  Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)

• Blood Marker : Glutathione (GSH)

  Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)

• Blood Marker : 8-Oxo-2'-deoxyguanosine (8-OxodG)

  Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)

• Blood Marker : 5-hydroxymethyl-deoxyuridine (5-OHmdU)

  Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)

Study Arms (2)

A2 Milk

ACTIVE COMPARATOR

A2 milk, 275 mL, twice daily after meal (550 mL/day)

Other: A2 Milk

A1/A2 milk

PLACEBO COMPARATOR

A1/A2 milk, 275 mL, twice daily after meal (550 mL/day)

Other: A1/A2 Milk

Interventions

A2 Milk OTHER

Cow's milk that contains only A2 β-Casein

A2 Milk

A1/A2 Milk OTHER

Cow's milk that contains both A1 β-Casein and A2 β-Casein

A1/A2 milk

Eligibility Criteria

• Age: 19 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 19 to 65 years of age
• 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)
• Those who have agreed to participate and given written consent through the Informed Consent Form prior to the study

You may not qualify if:

• Currently undergoing treatment for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary, renal an durinary, 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
• History of bowel obstruction
• Hospitalized within the last 3 months of Visit 1
• Has taken the following drugs or foods within 3 months of visit 1
• 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.}
• ② Psychiatric drugs such as antidepressants and antipsychotics
• ③ Diuretics
• ④ Systemic steroid preparations and hormonal preparations (including oral contraceptives and thyroid hormone preparations
• Has taken immunosuppressive drugs or anti inflammatory drugs within the last month (30 days) of Visit 1
• Administered systemic antibiotics, systemic antibacterial agents, colonics, bowel cleansers, probiotics, prebiotics, antioxidant related health 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
• 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
• 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/we ek) for women.
• Pregnant, breastfeeding, or planning to become pregnant during the study period

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, South Korea, 13620, South Korea

Location

Study Officials

• Nayoung Kim, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 11, 2025
• Study Start: February 26, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)