Obesity and metabolic syndrome Nutritional, Metabolic, Endocrine Obesity and metabolic syndrome
Conditions
Interventions
Participants are randomised to consume two dietary interventions in a random order. Each intervention period lasts for a total of eight weeks, with a four week wash out period between them.
Sponsors
Instituto de Salud Carlos III
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 20/04/2021: 1. Men and women 2. 30-60 years old - updated 17/10/2018: 30-65 years old 3. BMI=25 and <35 kg/m2 4. =3 Metabolic Syndrome criteria according to the ATP III harmonised criteria (doi: 10.1016/j.amjcard.2006.08.045) 4.1. Hypertension or hypertension treatment 4.2. Altered glycemia (=100mg/dl) or treatment 4.3. HDL cholesterol (men<40mg/dl or women <50mg/dl) or treatment 4.4. Altered triglycerides (=150mg/dl) or treatment 4.5. Abnormal waist circumference (men = 102cm or women = 88) 5. Following a non-Mediterranean Diet (scoring =9 in the 17-items MedDiet score used in the PREDIMED-Plus intervention trial) (questionnaire available at doi: 10.1093/ije/dyy225) Previous inclusion criteria: 1. Men and women 2. 30-60 years old - updated 17/10/2018: 30-65 years old 3. BMI=25 and <35 4. =3 Metabolic Syndrome criteria: 4.1. Hypertension or hypertension treatment 4.2. Altered glycemia (=100mg/dl) 4.3. HDL cholesterol (men<40mg/dl or women <50mg/dl) 4.4. Altered triglycerides (=150mg/dl) 4.5. Abnormal waist circumference (men = 102cm or women = 88)
Exclusion criteria
Exclusion criteria: Current inclusion criteria as of 20/04/2021: 1. BMI159mmHg; Diastolic arterial pressure (DAP)>99mmHg) 5. LDL cholesterol >160mg/dl 6. Tryglicerides >400mg/dl 7. Mediterranean adscription punctuation >9 (17-items MedDiet PREDIMED Plus questionnaire) 8. Frequent nuts consumption (=90g/week) 9. Different chronic diseases (inflammatory, infectious, chronic obstructive pulmonary, neoplasias, endocrine, or hematological diseases) 10. Leucocytosis (leucocytes >11x10E9) 11.Pharmacological treatment (anti-inflammatory, corticoids, hormones or antibiotics) 12. Changes of hypertension of lipidic profile medication (last 3 months). 13. Body weight loss (>5kg in the last 3 months). 14. Lost weight medication changes (last 3 months). 15. Breeding or pregnancy. 16. Diseases history (hepatic cirrhosis, intestinal inflammatory, intestinal resection). 17. Nuts allergy. 18. Probiotics, prebiotics or laxatives consumption Previous exclusion criteria: 1. BMI159mmHg; Diastolic arterial pressure (DAP)>99mmHg) 5. LDL cholesterol >160mg/dl 6. Tryglicerides >400mg/dl 7. Mediterranean adscription punctuation =7 (PREDIMED trial) 8. Frequent nuts consumption (=90g/week) 9. Frequent legumes consumption (=120g/week) 10. Different chronic diseases (inflammatory, infectious, chronic obstructive pulmonary, neoplasias, endocrine, or hematological diseases) 11. Leucocytosis (leucocytes >11x10E9) 12.Pharmacological treatment (anti-inflammatory, corticoids, hormones or antibiotics) 13. Changes of diabetes, hypertension of lipidic profile medication (last 3 months). 14. Body weight loss (>5kg in the last 3 months). 15. Lost weight medication changes (last 3 months). 16. Breeding or pregnancy. 17. Diseases history (hepatic cirrhosis, intestinal inflammatory, intestinal resection). 18. Nuts or legumes allergy. 19. Probiotics, prebiotics or laxatives consumption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 09/12/2020: Faecal microbiota is assessed through measuring the taxonomic composition in faeces (16S RNA) and quantitative metagenomic analysis at baseline and 8 weeks in each intervention period. Previous primary outcome measure: Metabolic risk markers are assessed by measuring glucose and lipid profile, inflammation, oxidation, and endothelial function markers by routine methods, ELISA and Luminex platform at baseline and 8 weeks in each intervention period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 09/12/2020: Metabolic risk markers are assessed by measuring glucose and lipid profile, inflammation, oxidation, and endothelial function markers by routine methods, ELISA and Luminex platform at baseline and 8 weeks in each intervention period. Previous secondary outcome measures: Faecal microbiota is assessed through measuring the taxonomic composition in faeces (16S RNA) and quantitative metagenomic analysis at baseline and 8 weeks in each intervention period. | — |
Countries
Spain
Outcome results
None listed