Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/04/2007
Date assigned
13/04/2007
Last edited
21/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Silvio Buscemi

ORCID ID

Contact details

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

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 measures

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

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

http://www.unipa.it/

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19302563

Publication citations

  1. 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.

Additional files

Editorial Notes