Short and middle term comparison of the effects of hypocaloric low carbohydrate diet versus Mediterranean diet on endothelial function measured by means of flow mediated dilation

ISRCTN	ISRCTN53451414
DOI	https://doi.org/10.1186/ISRCTN53451414
Protocol serial number	01/2007
Sponsor	University of Palermo (Italy)
Funder	Italian Ministry of the University of Scientific and Technological Research (Ministero Dell'università E Della Ricerca Scientifica E Tectnologica [MURST]) (Italy) - 60% funds

Submission date: 02/04/2007
Registration date: 13/04/2007
Last edited: 21/04/2009

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

Contact information

Prof Silvio Buscemi
Scientific

Dipartimento di Medicina Interna, malattie cardiovascolari e nefrourologiche
Via del vespro, 129
Palermo
90127
Italy

Study information

Primary study design	Interventional
Study design	Longitudinal, randomised, open study.
Secondary study design	Single-centre
Scientific title
Study objectives	Different nutritional aproaches to obesity might influence a different endothelial function.
Ethics approval(s)	Approval received from the local Ethical Committee of the University of the Studies of Palermo on the 6th June 2007 (ref: 7/07). Ethics approval was not necessary before the first patient was recruited for several reasons: 1. The enrolled subjects are obese people that spontaneously ask a dietetic treatment for losing weight 2. No drugs are administered 3. Two safe hypocaloric diets that are traditionally employed in the clinical field are compared (the low carbohydrate diet and the Mediterranean diet) 4. Participants are asked for a written informed consent before participation 5. The sudy is performed according to the Helsinki declaration 6. There is no conflict of interest and the study has no external sponsor to the University (Italian Ministery of University and Scientific and Technological Research) 7. No invasive measurements are performed
Health condition(s) or problem(s) studied	Obesity
Intervention	Group one: hypocaloric low carbohydrate diet for two months Group two: hypocaloric Mediterranean diet for two months
Intervention type	Other
Primary outcome measure(s)	Short (five to seven days) and middle (two months) modifications of flow mediated dilation. These will be measured three times: 1. Before starting the diet treatment 2. Five to seven days after starting the diet treatment 3. Two months after starting the diet treatment
Key secondary outcome measure(s)	1. Traditional anthropometric, metabolic and cardiovascular risk factors 2. Intra-renal haemodinamic measurements (resistance and pulsatility indexes) These will be measured three times: 1. Before starting the diet treatment 2. Five to seven days after starting the diet treatment 3. Two months after starting the diet treatment
Completion date	30/04/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	20
Key inclusion criteria	1. Female subjects 2. Range of age 30 to 50 years 3. Range of Body Mass Index (BMI) from 27 kg/m^2 to 39.9 kg/m^2 4. Non-diabetic, non-hypertensive, non-dislipidemic subjects
Key exclusion criteria	1. Any metabolic, cardiovascular or systemic disease 2. Any drug treatment
Date of first enrolment	01/10/2006
Date of final enrolment	30/04/2007

Locations

Countries of recruitment

Italy

Study participating centre

Dipartimento di Medicina Interna, malattie cardiovascolari e nefrourologiche

Palermo
90127
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/05/2009		Yes	No