Effect of dietary glycaemic load on body weight, inflammation and endothelial functio

Not Applicable

Completed

• Conditions: Obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN54971867
• Lead Sponsor: Pere Virgili Health Research Institute (Institut d'Investigació Sanitària Pere Virgili) (Spain)

Brief Summary

1. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24787494 2. 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29024341 3. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/28237295 (added 02/09/2019) 4. 2019 results in: http://www.ncbi.nlm.nih.gov/pubmed/29603657 [added 15/05/2019] 5. 2019 miRNA profile results in https://www.ncbi.nlm.nih.gov/pubmed/29233588 (added 26/03/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-15
• Study Completion: 2012-12-31
• Last Update Posted: 14 April 2020

Recruitment & Eligibility

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

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Weight loss, measured at baseline, after 15 days, and every month until end of study<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Adiposity measures, measured at baseline and end of study<br> 2. Blood sugar and insulin, measured at baseline and end of study<br> 3. Lipid profile, measured at baseline and end of study<br> 4. Markers of inflammation, measured at baseline and end of study<br> 5. Markers of endothelial function, measured at baseline and end of study<br> 6. Adipose tissue expression of inflammatory markers, measured at baseline and end of study<br> 7. Inflammatory post-prandial response, measured at first visit<br> 8. Satiety, measured at baseline, after 15 days, and every month until end of study<br>