Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01/2007
Study information
Scientific title
Acronym
Study hypothesis
Different nutritional aproaches to obesity might influence a different endothelial function.
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.
Primary study design
Interventional
Secondary study design
Single-centre
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Obesity
Intervention
Group one: hypocaloric low carbohydrate diet for two months
Group two: hypocaloric Mediterranean diet for two months
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
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
Overall trial start date
01/10/2006
Overall trial end date
30/04/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
20
Participant exclusion criteria
1. Any metabolic, cardiovascular or systemic disease
2. Any drug treatment
Recruitment start date
01/10/2006
Recruitment end date
30/04/2007
Locations
Countries of recruitment
Italy
Trial participating centre
Dipartimento di Medicina Interna, malattie cardiovascolari e nefrourologiche
Palermo
90127
Italy
Sponsor information
Organisation
University of Palermo (Italy)
Sponsor details
Piazza Marina
Palermo
90100
Italy
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Italian Ministry of the University of Scientific and Technological Research (Ministero Dell'università E Della Ricerca Scientifica E Tectnologica [MURST]) (Italy) - 60% funds
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
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19302563
Publication citations
-
Results
Buscemi S, Verga S, Tranchina MR, Cottone S, Cerasola G, Effects of hypocaloric very-low-carbohydrate diet vs. Mediterranean diet on endothelial function in obese women*., Eur. J. Clin. Invest., 2009, 39, 5, 339-347, doi: 10.1111/j.1365-2362.2009.02091.x.