ISRCTN15658653进行中（未招募）Unknown
Determination of the health impacts of milk kefir on healthy and metabolic syndrome subjects DOMINO study
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 122
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Healthy participants inclusion criteria:
- •1. General good health
- •2. Both gender
- •3. BMI between 20 and 29.9 kg/m2
- •4. Aged between 18 and 60 years old
- •5. Willing to take one daily portion of kefir or placebo and to follow the procedures as well as a 2-3h metabolic exploration day every month of follow-up
- •6. Written informed consent
- •Metabolic syndrome participants inclusion criteria:
- •1. Aged between 18 and 65 years old
- •2. Subjects diagnosed with metabolic syndrome according to the International Diabetes Federation (IDF) criteria
- •3. Low consumption (max intake 3 servings/week) of kefir or supplements/foods labelled as having probiotic effect during the prior 3 months
- •4. Consumption of fruits and vegetables = 3 servings per day
- •5. Willing to take one daily portion of kefir or placebo and to follow the procedures as well as a 2-3h metabolic exploration day every month of follow-up
- •6. Written informed consent
排除标准
- •Healthy participants exclusion criteria:
- •1. BMI =30 kg/m2
- •2. Gastrointestinal disorders of any kind
- •3. Previous abdominal surgery
- •4. Lactose intolerance or intolerance to the study products
- •5. Blood triglyceride > 150 mg/dL
- •6. Blood total cholesterol > 240 mg/dL or HDL-cholesterol <40 mg/dl (men) or < 50 mg/dl (women)
- •7. Blood pressure =140/90 mm Hg or taking blood pressure medications
- •8. Fasting blood glucose >105 mg/dL
- •9. Pharmacological treatments of any type at enrolment and in the 2 months before the study
- •10. Consumption of supplements or foods labelled as having a probiotic effect prior 3 months
- •11. Consumption of Kefir > 3 servings/week during the prior 3 months
- •12. Menopause women
- •13. Alcohol consumption exceeding 30g of alcohol/day (1 alcoholic beverage dose = 10g of alcohol) or proven abuse or dependence on another drug. Consumption of more than 3 alcoholic beverages per day is considered abusive. An alcoholic beverage corresponds, for example, to 30 ml of spirits, 120 ml of wine or 330 ml of beer
- •14. Consumption of fruits and vegetables > 5 servings per day
- •15. Dietary fibre intake > 30g/1000 kcal per day
- •16. Pregnant, parturient or breast-feeding woman; for women of childbearing age: positive urine pregnancy test
- •17. Antibiotics consumption over the prior 1 month before the trial
- •18. Daily use of laxatives in the 3 months before explorations, or use of drugs that may strongly interfere with the composition of the intestinal microbiota
- •19. Contemporary participation in other studies
- •20. Blood donors in the last 2 months
- •21. Use of lipid-lowering drugs
- •22. Under antidiabetic treatment
- •23. Individuals who have lost/ gained = 3 kg in the last 3 months
- •24. Individuals with unstable medical or psychological conditions which, in the investigator's opinion, could lead the volunteer to be non-compliant or uncooperative during the study, or which could compromise the volunteer's safety or participation in the study
- •25. Pre-diabetes, type 1 or 2 diabetes
- •26. Cancer
- •27. Infectious diseases
- •28. Cardiovascular disease
- •29. Hypertension
- •30. Severe eating disorders (anorexia/bulimia, binge eating disorder, noctophagia, etc.)
- •31. Severe chronic renal failure (GFR<60mL/min)
- •32. Hepatocellular insufficiency
- •33. Exocrine pancreatic insufficiency
- •34. Known endocrine pathology inducing hyperglycaemia (uncontrolled dysthyroid, acromegaly, hypercorticism, etc.)
- •35. Previous intestinal or abdominal surgery, bariatric surgery, gallbladder surgery, polyp removal, known gastroparesis, total gastrectomy or colectomy
- •36. Pathology detectable on clinical examination and medical questioning that may interfere with the study's evaluation criteria
- •37. Adult subject to a legal protection measure (guardianship, curatorship)
- •38. Person deprived of liberty by judicial or administrative decision
- •Metabolic syndrome participants exclusion criteria:
- •1. Lactose intolerance
- •2. Type 1 diabetes
- •3. Abnormal thyroid hormone levels
- •4. Chronic gastrointestinal system disease
- •6. Severe liver disease
- •7. Kidney insufficiency
- •8. Immunodeficiency
- •9. Taking medication to regulate blood glucose (except metformin) or lipid levels
- •10. Taking antibiotics prior to one month of the study
- •11. Taking supplement which may affect the metabolic outcomes such as prebiotic or omega-3
- 另有 3 项未显示
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