Metabolic syndrome Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants will attend two 4-day inpatient stays at the NIHR Imperial Clinical Research Facility (CRF), separated by at least one week. This is a double-blind, randomized crossover trial. Eligible p
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. 18-65 years old 2. Subjects diagnosed with metabolic syndrome according to the International Diabetes Federation (IDF) criteria (file://icnas1.cc.ic.ac.uk/igarciap/downloads/IDF_Meta_def_final.pdf) 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 2-3 h metabolic exploration day every month of follow-up 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Existence of lactose intolerance 2. Existence of type 1 diabetes 3. Existence of abnormal thyroid hormone levels 4. Existence of chronic gastrointestinal system disease 5. Existence of cancer 6. Existence of severe liver disease 7. Existence of kidney insufficiency 8. Existence of immunodeficiency 9. Presence of a pacemaker or other implanted electromedical device 10. Taking medication to regulate blood glucose (except metformin) or lipid levels for less than 3 months 11. Taking antibiotics prior to one month of the study 12. Taking supplement which may affect the metabolic outcomes such as prebiotic or omega-3 13. Dieting for weight loss or for another disease 14. Adherence to a vegetarian or vegan diet 15. Pregnant, parturient, or breastfeeding woman; for women of childbearing age: positive urine pregnancy test 16. Alcohol consumption exceeding 30 g of alcohol/day (1 alcoholic beverage dose = 10 g 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 17. Contemporary participation in other studies 18. Blood donors in the last 2 months 19. Pathology detectable on clinical examination and medical questioning that may interfere with the study's evaluation criteria 20. Adult subject to a legal protection measure (guardianship, curatorship) 21. Person deprived of liberty by judicial or administrative decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Digestive tract metabolites and microbiome composition measured using ¹H NMR spectroscopy, mass spectrometry (MS) chromatography, and microbiological analysis (16S rRNA sequencing) at baseline and multiple post-consumption intervals on Day 2 (ileal) and Day 4 (gastric/duodenal) | — |
Secondary
| Measure | Time frame |
|---|---|
| Identification of urinary and stool biomarkers of kefir intake measured using metabolomic analysis (¹H NMR spectroscopy and mass spectrometry) of urine and stool samples at daily during the two 4-day inpatient stays | — |
Countries
England, United Kingdom
Contacts
Public ContactIsabel;Vally Yiwei Garcia-Perez;Wu
;
Outcome results
None listed