Condition category
Nutritional, Metabolic, Endocrine
Date applied
01/06/2006
Date assigned
19/06/2006
Last edited
02/12/2010
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

Dr Jordi Salas-Salvadó

ORCID ID

Contact details

C/Sant Llorenç 21
Reus
43201
Spain
+34 (0)97 775 93 13
jordi.salas@urv.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AGL2005-03605

Study information

Scientific title

Acronym

EFINUT

Study hypothesis

Regular nut consumption improves cardiovascular risk factors in metabolic syndrome patients without adverse effects on energy balance and insulin sensitivity

Ethics approval

Approved by Sant Joan Hospital Ethical Committee, reference number: EFINUT-05-01-27/1proj2

Study design

Randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Peripheral inflammatory markers

Secondary outcome measures

1. Stress oxidative markers
2. Endothelial function
3. Insulin sensitivity
4. Energy balance

Overall trial start date

08/01/2006

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with metabolic syndrome aged between 18 and 65 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50; male and female

Participant 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

Recruitment start date

08/01/2006

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Spain

Trial participating centre

C/Sant Llorenç 21
Reus
43201
Spain

Sponsor information

Organisation

Ministry of Education and Science (Ministerio de Educacion y Ciencia) (Spain)

Sponsor details

Paseo de la Castellana
160 Pta 12
Madrid
28071
Spain
+34 (0)91 349 40 00
dtcv@mec.es

Sponsor type

Government

Website

http://www.mec.es

Funders

Funder type

Government

Funder name

Ministry of Education and Science (Ministerio de Educacion y Ciencia)

Alternative name(s)

Ministry of Education and Science

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Portugal

Funder name

International Nut Council

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20064680

Publication citations

  1. Results

    López-Uriarte P, Nogués R, Saez G, Bulló M, Romeu M, Masana L, Tormos C, Casas-Agustench P, Salas-Salvadó J, Effect of nut consumption on oxidative stress and the endothelial function in metabolic syndrome., Clin Nutr, 2010, 29, 3, 373-380, doi: 10.1016/j.clnu.2009.12.008.

Additional files

Editorial Notes