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临床试验/NCT06870097
NCT06870097进行中(未招募)不适用

An 8 Week, Stratified Randomiz Ation , Double Blind , Crossover , Placebo Controlled Trial for the Evaluation of the the Effects of A2 Milk on Gut Beneficial Bacteria Growth, Antioxidant Activity, Digestion, and Inflammation Improvement

Seoul National University Bundang Hospital2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2025年2月26日最近更新:
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
100
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 effects of A2 milk on gut beneficial bacteria growth, antioxidant activity , digestion, and inflammation improvement

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. In addition, there are reports that blood GSH levels, intestinal short chain fatty acids (Acetic acid, butanoic acid), and intestinal beneficial bacteria (Bifidobacterium genus) content are increased.

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
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • 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
  • Allergic to dairy products (bloody stool, muscle/joint pain, headache, dizziness, coma, short term memory impairment, oral ulcer, cardiac arrhythmia, sore throat, increased frequency of urination, acne, depression)
  • 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: Screening (week -2), 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 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.

次要结局

  • 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 : High Sensitive C-reactive protein (hs-CRP)(Screening (week -2), 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 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;)
  • 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 : Tumor necrosis factor-α (TNF-α)(Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6))
  • Blood Marker : β-casomorphin-7 (BCM-7)(Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6))
  • Blood Marker : β casomorphin-10 (BCM-10)(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 : Interleukin-4 (IL-4)(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))
  • 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))
  • Blood marker : Interleukin-6 (IL-6)(Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6))
  • Blood Marker : Dipeptidyl Peptidase-4 (DPP-IV)(Screening (week -2), 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))
  • 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))
  • 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))

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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