Effect of a diet of healthy food or a Mediterranean diet on change in the composition and function of faecal microbiota
- Conditions
- Obesity and metabolic syndromeNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN88780852
- Lead Sponsor
- Instituto de Salud Carlos III
- Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34130026/ (added 17/06/2021) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34959869/ (added 07/06/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 44
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)
Current inclusion criteria as of 20/04/2021:
1. BMI<25kg/m2 or BMI=35
2. Type 2 diabetes
3. Secondary obesity or related pathologies
4. Non-controlled hypertension (Systolic arterial pressure (SAP)>159mmHg; 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. BMI<25kg/m2 or BMI=35
2. Type 2 diabetes
3. Secondary obesity or related pahologies
4. Non-controlled hypertension (Systolic arterial pressure (SAP)>159mmHg; 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Current primary outcome measure as of 09/12/2020:<br> 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.<br><br> Previous primary outcome measure:<br> 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.<br>
- Secondary Outcome Measures
Name Time Method <br> Current secondary outcome measures as of 09/12/2020:<br> 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.<br><br> Previous secondary outcome measures:<br> 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.<br>