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临床试验/NCT06252636
NCT06252636进行中(未招募)不适用

An 8-week, Randomized, Double-Blind, Crossover, Placebo-Controlled Trial for the Evaluation of the Efficacy and Safety of A2 Milk on Digestion

Seoul National University Bundang Hospital2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2023年4月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
2
主要终点
Gastrointestinal Symptom Rating Scale (GSRS) Total Score

研究概览

简要总结

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.

详细描述

Milk has a high calcium content, and calcium in milk is easily digested and absorbed and has an excellent utilization rate in the body. Milk is rich in lactose, Vitamin D, and peptides that facilitate calcium absorption, and it also contains essential amino acids and bioactive substances that are beneficial to health. Regularly drinking milk has been proven to improve insulin sensitivity, blood pressure, and serum lipid concentrations. Furthermore, milk is reported to be an effective food for nutritional supplementation and improvement in the diet of Koreans, as it contains a well-balanced source of essential amino acids that can be lacking in a rice-centric diet, along with quality animal protein, calcium, vitamin B2, and other nutrients. However, this increase in dairy consumption can be associated with an increased risk for certain disorders, including digestive disorders.

The actual prevalence of lactose intolerance is unclear in Korea, and reports have ranged from 39.1% to 84.1%. In 2010, it was reported that in most individuals who believed they had lactose intolerance, no evidence of problems with lactose absorption could be found, and thus, gastrointestinal symptoms were unlikely to be associated with lactose. Alternatively, A1 β-Casein and β-Casomorphin-7 (BCM-7) has emerged as a major area for research in relation to digestive discomfort following milk consumption.

Milk is composed of 80% Casein protein and 20% whey. Among Casein proteins, β-Casein can be divided into the A1 type comprised of A1, B, C, F, and G, and the A2 type with A2, A3, D, E, H, I, and J variants. A1 and A2 type β-Casein proteins differ in their 67th amino acid, with A1 containing Histidine and B2 with Proline. The other remaining variants are only found in low levels or not found in European cattle. Furthermore, BCM-7, which is produced when enzymatic cleavage at the histidine position occurs in A1 β-Casein, has been associated with digestive discomfort. Additionally, milk containing A1 β-Casein has been linked to type 1 diabetes and heart disease. Nevertheless, the majority of dairy cattle in dairy industries continue to produce milk containing A1 β-Casein.

Animal tests have shown that milk with A1 β-Casein takes longer to transit through the digestive tract compared to A2 β-Casein containing milk. In addition, a clinical trial reported that the Bristol stool scores in participants who consumed A1 β-Casein milk were higher than those in A2 β-Casein milk. Another clinical trial announced that A2 β-Casein milk alleviated gastrointestinal symptoms of milk hypersensitivity.

Therefore, this study aims to evaluate the efficacy and safety of A2 milk compared to a control (A1/A2 milk) in individuals who experience discomfort after consuming milk.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

A2 Milk

Active Comparator

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

干预措施: A2 Milk (Other)

A1/A2 Milk

Placebo Comparator

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

干预措施: A1/A2 Milk (Other)

结局指标

主要结局

Gastrointestinal Symptom Rating Scale (GSRS) Total Score

时间窗: Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)

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.

次要结局

  • Blood marker - β-casomorphin-7 (BCM-7)(Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6))
  • Upper Abdominal Gastrointestinal Symptom Rating Scale (GSRS) Score(Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6))
  • Stool marker - Calprotectin(Stool collection kit provided on Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4); 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))
  • Stool marker - Short-chain Fatty Acid (SCFA)(Stool collection kit provided on Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4); Retrieved on 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))
  • Blood marker - Interleukin-4 (IL-4)(Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6))
  • Blood marker - Immunoglobulin E (IgE)(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))
  • Blood marker - Immunoglobulin G (IgG) and Immunoglobulin G1 (IgG1)(Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6))
  • Stool marker - Microbiome(Stool collection kit provided on Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4); Retrieved on 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nayoung Kim

Professor

Seoul National University Bundang Hospital

研究点 (2)

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