Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PV10046S
Study information
Scientific title
Effect of dietary glycaemic load on body weight, inflammation and endothelial function: a randomised controlled trial
Acronym
GLYNDIET
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.
Ethics approval
Institutional Review Board of the Hospital Universitario Sant Joan de Reus, Spain, 26/02/2009
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Obesity
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Weight loss, measured at baseline, after 15 days, and every month until end of study
Secondary outcome measures
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
Overall trial start date
03/02/2010
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Men and women aged between 30 - 60 years
2. Body mass index (BMI) between 27 and 35 kg/m^2
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
n = 117
Total final enrolment
122
Participant 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
Recruitment start date
03/02/2010
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Spain
Trial participating centre
Institut d'Investigacions Sanitàries Pere i Virgili
Reus
43201
Spain
Sponsor information
Organisation
Pere Virgili Health Research Institute (Institut d'Investigació Sanitària Pere Virgili) (Spain)
Sponsor details
Sant Llorenc 21
Reus
43201
Spain
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Pere Virgili Health Research Institute (Institut d'Investigació Sanitària Pere Virgili) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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)