Harnessing the potential of fermentation for healthy and sustainable foods

Not Applicable

• Conditions: Assessing the effects of kefir consumption in both healthy subjects and those with metabolic syndrome (MetS).; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN15658653
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-27
• Last Update Posted: 15 April 2024
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

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

Exclusion Criteria

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
5. Cancer
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
12. Dieting for weight loss or for another disease
13. Pregnant, parturient, or breast-feeding woman; for women of childbearing age: positive urine pregnancy test
14. Alcohol consumption exceeding 30g

Study & Design

• Study Type: Interventional
• Study Design: Not specified