Evaluation of the Efficacy and Safety of A2 Milk on Digestion

NCT06252636 | Active Not Recruiting

• 1 other identifier: B-2302-808-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

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 4-point Likert-type scale from 0 (no symptoms or normal) to 3 (severe symptoms) to rate 15 symptom items including both upper and lower abdominal symptoms. Participants will be given the GSRS to complete.

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

Secondary Outcomes (12)

• Upper Abdominal Gastrointestinal Symptom Rating Scale (GSRS) Score

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

• Lower Abdominal (Gastrointestinal Symptom Rating Scale) GSRS Score

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

• Digestive Discomfort Symptom Survey

  Surveys given on Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4) to record daily; Retrieved on Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)

• Bowel Frequency and Form

  Journal provided on Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4) to record daily; Retrieved on Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)

• Blood Marker - High Sensitive C-reactive protein (hs-CRP)

  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: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Administered antibiotics or laxatives within the last 2 weeks of Visit 2
• 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.)}
• Pregnant, breastfeeding, or planning to become pregnant during the study period
• Allergic to dairy products
• 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
• Individuals deemed inappropriate for the study by the investigator

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Related Publications (1)

• Choi Y, Kim N, Song CH, Kim S, Lee DH. The Effect of A2 Milk on Gastrointestinal Symptoms in Comparison to A1/A2 Milk: A Single-center, Randomized, Double-blind, Cross-over Study. J Cancer Prev. 2024 Jun 30;29(2):45-53. doi: 10.15430/JCP.24.007.

  PMID: 38957588 DERIVED

Study Officials

• Nayoung Kim, MD, 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: January 16, 2024
• First Posted: February 12, 2024
• Study Start: April 7, 2023
• Primary Completion: November 20, 2023
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

KR (1)