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 |
| Secondary identifying numbers | 01/2007 |
- 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
Scientific
Dipartimento di Medicina Interna, malattie cardiovascolari e nefrourologiche
Via del vespro, 129
Palermo
90127
Italy
Study information
| Study design | Longitudinal, randomised, open study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-centre |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/10/2006 |
| Completion date | 30/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
90127
Italy
Sponsor information
University of Palermo (Italy)
University/education
University/education
Piazza Marina
Palermo
90100
Italy
| Website | http://www.unipa.it/ |
|---|---|
"ROR" |
https://ror.org/044k9ta02 |
Funders
Funder type
Government
Italian Ministry of the University of Scientific and Technological Research (Ministero Dell'università E Della Ricerca Scientifica E Tectnologica [MURST]) (Italy) - 60% funds
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
