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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 10.1186/ISRCTN53451414
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym N/A
Serial number at source 01/2007
Study hypothesis Different nutritional aproaches to obesity might influence a different endothelial function.
Lay summary
Ethics approval 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
Study design Longitudinal, randomised, open study.
Countries of recruitment Italy
Disease/condition/study domain Obesity
Participants - 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
Participants - exclusion criteria 1. Any metabolic, cardiovascular or systemic disease
2. Any drug treatment
Anticipated start date 01/10/2006
Anticipated end date 30/04/2007
Status of trial Completed
Patient information material
Target number of participants 20
Interventions Group one: hypocaloric low carbohydrate diet for two months
Group two: hypocaloric Mediterranean diet for two months
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
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
Sources of funding Italian Ministry of the University of Scientific and Technological Research (Ministero Dell'università E Della Ricerca Scientifica E Tectnologica [MURST]) (Italy) - 60% funds
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19302563
Contact name Prof  Silvio  Buscemi
  Address Dipartimento di Medicina Interna, malattie cardiovascolari e nefrourologiche
Via del vespro, 129
  City/town Palermo
  Zip/Postcode 90127
  Country Italy
Sponsor University of Palermo (Italy)
  Address Piazza Marina
  City/town Palermo
  Zip/Postcode 90100
  Country Italy
  Sponsor website: http://www.unipa.it/
Date applied 02/04/2007
Last edited 21/04/2009
Date ISRCTN assigned 13/04/2007
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