Obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
Participants are randomised into three groups stratified by sex, and presence of diabetes using random triplets:
1. Diet rich in low-glycaemic index carbohydrates (40% of energy from f
Sponsors
Pere Virgili Health Research Institute (Institut d'Investigació Sanitària Pere Virgili) (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged between 30 - 60 years 2. Body mass index (BMI) between 27 and 35 kg/m^2
Exclusion criteria
Exclusion criteria: 1. Non controlled type 2 diabetes mellitus (Hba1c greater than 8%) 2. Systolic blood pressure (SBP) greater than 159 mmHg and diastolic blood pressure (DBP) greater than 99 mmHg 3. Low density lipoprotein (LDL) cholesterol higher than 160 mg/dl 4. Triacylglycerol (TAG) higher than 400 mg/dl 5. Secondary overweight 6. Any inflammatory disease, infectious, chronic obstructive pulmonary, neoplastic, endocrine or haematological disease active at the time of the study 7. Leukocyte count greater than or equal to 11,000 cells x 10^6 8. Taking of anti-inflammatory drug therapy, steroids, hormones or antibiotics that could affect the parameters analysed in the study 9. Changes in medication for lipid profile, diabetes or hypertension in the past three months previous to the study 10. Active alcoholism or drug dependence, excluding tobacco 11. Highly restrictive diet for 3 months before the study or latest weight loss (more than 5 kg in the last 3 months) 12. Medical condition that discourages the inclusion in the study 13. The inability to understand it or the anticipated difficulty in making dietary changes according to the model of Prochaska and DiClemente
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss, measured at baseline, after 15 days, and every month until end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adiposity measures, measured at baseline and end of study 2. Blood sugar and insulin, measured at baseline and end of study 3. Lipid profile, measured at baseline and end of study 4. Markers of inflammation, measured at baseline and end of study 5. Markers of endothelial function, measured at baseline and end of study 6. Adipose tissue expression of inflammatory markers, measured at baseline and end of study 7. Inflammatory post-prandial response, measured at first visit 8. Satiety, measured at baseline, after 15 days, and every month until end of study | — |
Countries
Spain
Outcome results
None listed