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

ISRCTN	ISRCTN54971867
DOI	https://doi.org/10.1186/ISRCTN54971867
Secondary identifying numbers	PV10046S

Submission date: 10/06/2010
Registration date: 15/07/2010
Last edited: 26/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Mònica Bulló
Scientific

Institut d'Investigacions Sanitàries Pere i Virgili
Sant Llorenc 21
Reus
43201
Spain

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effect of dietary glycaemic load on body weight, inflammation and endothelial function: a randomised controlled trial
Study acronym	GLYNDIET
Study objectives	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(s)	Institutional Review Board of the Hospital Universitario Sant Joan de Reus, Spain, 26/02/2009
Health condition(s) or problem(s) studied	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
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 study start date	03/02/2010
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	n = 117
Total final enrolment	122
Key inclusion criteria	1. Men and women aged between 30 - 60 years 2. Body mass index (BMI) between 27 and 35 kg/m^2
Key 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
Date of first enrolment	03/02/2010
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Spain

Study participating centre

Institut d'Investigacions Sanitàries Pere i Virgili

Reus
43201
Spain

Sponsor information

Pere Virgili Health Research Institute (Institut d'Investigació Sanitària Pere Virgili) (Spain)
Research organisation

Sant Llorenc 21
Reus
43201
Spain

Website	http://www.iispv.cat/
"ROR"	https://ror.org/01av3a615

Funders

Funder type

Research organisation

Pere Virgili Health Research Institute (Institut d'Investigació Sanitària Pere Virgili) (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2014		Yes	No
Results article	results	01/01/2018		Yes	No
Results article	results	01/01/2019	15/05/2019	Yes	No
Results article	results	01/04/2018	02/09/2019	Yes	No
Results article	miRNA profile results	01/02/2019	26/03/2020	Yes	No

Editorial Notes

26/03/2020: Publication reference added.
02/09/2019: Publication reference added.
15/05/2019: Publication reference and total final enrolment added.
04/01/2019: Publication reference added.