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11 February 2012
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Effect of dietary glycaemic load on body weight, inflammation and endothelial function
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| ISRCTN | ISRCTN54971867 |
| ClinicalTrials.gov identifier | |
| Public title |
Effect of dietary glycaemic load on body weight, inflammation and endothelial function
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| Scientific title | Effect of dietary glycaemic load on body weight, inflammation and endothelial function: a randomised controlled trial |
| Acronym | GLYNDIET |
| Serial number at source | PV10046S |
| Study hypothesis | The acute or chronic intake of low-glycaemic foods will create loss of body weight and will generate a metabolic response associated with an improvement in systemic inflammatory pattern and markers of endothelial function compared to the consumption of high-glycaemic index carbohydrates or consumption of a low-fat diet. |
| Lay summary | |
| Ethics approval | Institutional Review Board of the Hospital Universitario Sant Joan de Reus, Spain, approved on the 26th February 2009 |
| Study design |
Randomised controlled trial
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| Countries of recruitment | Spain |
| Disease/condition/study domain | Obesity |
| Participants - inclusion criteria |
1. Men and women aged between 30 - 60 years
2. Body mass index (BMI) between 27 and 35 kg/m^2 |
| Participants - 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 |
| Anticipated start date | 03/02/2010 |
| Anticipated end date | 31/12/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | n = 117 |
| 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 fat, 42% of energy from low-glycaemic index carbohydrates, 18% of energy from proteins) 2. Diet rich in high-glycaemic index carbohydrates (40% of energy from fat, 42% of energy from high-glycaemic index carbohydrates, 18% of energy from proteins) 3. Low-fat diet (30% of energy from, 52% of energy from high-glycaemic index carbohydrates, 18% of energy from proteins) Total duration of treatment and follow-up is six months. |
| Primary outcome measure(s) |
Weight loss, measured at baseline, after 15 days, and every month until end of study
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| Secondary outcome measure(s) |
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 |
| Sources of funding | Pere Virgili Health Research Institute (Institut d'Investigació Sanitària Pere Virgili) (Spain) |
| Trial website | http://www.glyndiet.org/ |
| Publications | |
| Contact name | Dr Mònica Bulló |
| Address |
Institut d'Investigacions Sanitàries Pere i Virgili
Sant Llorenc 21 |
| City/town | Reus |
| Zip/Postcode | 43201 |
| Country | Spain |
| Sponsor | Pere Virgili Health Research Institute (Institut d'Investigació Sanitària Pere Virgili) (Spain) |
| Address | Sant Llorenc 21 |
| City/town | Reus |
| Zip/Postcode | 43201 |
| Country | Spain |
| Sponsor website: | http://www.iispv.cat/ |
| Date applied | 10/06/2010 |
| Last edited | 21/09/2010 |
| Date ISRCTN assigned | 15/07/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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