Evaluation of the effect of nut consumption on energy balance, metabolic, inflammatory response and oxidation
| ISRCTN | ISRCTN36468613 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36468613 |
| Protocol serial number | AGL2005-03605 |
| Sponsor | Ministry of Education and Science (Ministerio de Educacion y Ciencia) (Spain) |
| Funders | Ministry of Education and Science (Ministerio de Educacion y Ciencia), International Nut Council |
- Submission date
- 01/06/2006
- Registration date
- 19/06/2006
- Last edited
- 02/12/2010
- 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
Dr Jordi Salas-Salvadó
Scientific
Scientific
C/Sant Llorenç 21
Reus
43201
Spain
| Phone | +34 (0)97 775 93 13 |
|---|---|
| jordi.salas@urv.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | EFINUT |
| Study objectives | Regular nut consumption improves cardiovascular risk factors in metabolic syndrome patients without adverse effects on energy balance and insulin sensitivity |
| Ethics approval(s) | Approved by Sant Joan Hospital Ethical Committee, reference number: EFINUT-05-01-27/1proj2 |
| Health condition(s) or problem(s) studied | Metabolic syndrome |
| Intervention | Participants are randomly assigned into two equal groups: 1. Control group: low-fat diet according to American Heart Association guidelines 2. Nut group: low-fat diet according to American Heart Association guidelines with an added 30 g/day of nuts |
| Intervention type | Other |
| Primary outcome measure(s) |
Peripheral inflammatory markers |
| Key secondary outcome measure(s) |
1. Stress oxidative markers |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | Patients with metabolic syndrome aged between 18 and 65 years |
| Key exclusion criteria | 1. Nut allergy 2. Type 2 diabetes 3. Body mass index (BMI) >33 kg/m^2 4. Secondary obesity 5. Inflammatory or infectious disease 6. Anti-inflammatory or antibiotic drugs 7. Alcoholism or drug abuse 8. Recent hypocaloric diet |
| Date of first enrolment | 08/01/2006 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Spain
Study participating centre
C/Sant Llorenç 21
Reus
43201
Spain
43201
Spain
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 | 01/06/2010 | Yes | No |
