Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/06/2010
Date assigned
15/07/2010
Last edited
06/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.glyndiet.org/

Contact information

Type

Scientific

Primary contact

Dr Mònica Bulló

ORCID ID

Contact details

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

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 measures

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

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

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

http://www.iispv.cat/

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24787494

Publication citations

Additional files

Editorial Notes