Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/03/2010
Date assigned
30/04/2010
Last edited
30/04/2010
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

Ms Sandra Daponte

ORCID ID

Contact details

C/Choupana S/N
Santiago De Compostela
15706
Spain
+34 981 951 193
sandra.daponte.angueira@sergas.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33UT08011

Study information

Scientific title

The evaluation of health benefits of hake consumption in a high cardiovascular risk population: a randomised cross-over open nutritional interventional study

Acronym

Study hypothesis

The following main hypothesis is raised: Frequent hake intake improves the individual components of the metabolic syndrome (blood pressure, lipid profile and body weight) in patients with high cardiovascular risk, and therefore yield the specific health claims for hake labelling.

Ethics approval

Reference Review Board of the Comite Etico de Investigacion Clinica de Galicia approved on the 27th July 2008. An amendment was approved on the 31st March 2009.

Study design

Randomised cross-over open trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Can be found at http://www.ciberobn.es/webciber/index.php?option=com_phocadownload&view=category&id=6:oficina-de-proyectos&download=2:crd_proyecto33ut08011&Itemid=11 (Spanish only)

Condition

Metabolic syndrome

Intervention

Control period:
Patients are put under basic alimentary roles of a balanced diet, except for the total absence of fish intake. This will last for 8 weeks.

Intervention period:
Patients are put under basic alimentary roles of a balanced diet, but in this case they take 7 servings of white fish a week.

During the study period, all subjects will follow medical advice as well as prescribed medications by the responsible medical team attending the patients, except for the interventions described above. All the education and information given to the patients will aim to only modify fish intake, which will always be Pescanova Hake, or total absence of fish intake. For the rest of items of the diet, following the general principles of a balanced diet, patients will be told to feel free to chose foods according to their preferences as to avoid biases which could affect a short-term study.

This is a randomised cross-over open trial, with an intervention period of 8 weeks and a control one of 8 weeks. The total duration of the trial is 16 weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Serum triglyceride concentrations, measured at the inclusion time and at the end of each intervention period (3 measurements altogether)

Secondary outcome measures

Measured at the inclusion time and at the end of each intervention period (3 measurements altogether):
1. Other components of the metabolic syndrome as defined by the ATP III
2. Anthropometric variables: height, weight, waist and hip circumferences
3. Biochemical markers and chronic inflammation markers
4. Adherence and feasibility of the nutritional intervention
5. Erythrocyte membrane omega-3 concentrations
6. Insulin resistance (Homeostatic Model Assessment [HOMA])

Overall trial start date

25/02/2009

Overall trial end date

01/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 18 and 75 years, either sex
2. Recruited in outpatients clinics of the participant centres
3. Voluntarily agree with the study protocol and give written informed consent
4. Thorough clinical history and informative meeting has been performed
5. Metabolic syndrome (primary intervention). The presence of metabolic syndrome according to 2004 ATP-III (Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults) criteria will be evaluated. According to the latter, for the diagnosis of the metabolic syndrome, three or more of the following criteria have to be present:
5.1. Central obesity: waist circumference greater than 102 cm in men and greater than 88 cm in women
5.2. Hypertriglyceridemia: triglycerides greater than or equal to 150 mg/dL (greater than or equal to 1.7 mmol/L) or on treatment
5.3. High density lipoprotein (HDL) less than 40 mg/dL (less than 1.1 mmol/L) in men or less than 50 mg/dL (1.3 mmol/L) in women
5.4. Hypertension: systolic blood pressure greater than or equal to 130 mmHg and/or diastolic greater than or equal to 85 mmHg, or on treatment
5.5. Fasting blood glucose greater than or equal to 100 mg/dL (greater than or equal to 5.6 mmol/L) or any other carbohydrate metabolism disorder (including diabetes and glucose intolerance)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

250 Caucasians of Spanish origin

Participant exclusion criteria

Those who presented any of the following after a thorough clinical history:
1. Previous allergy to fish or Anisakis infection
2. Morbid obesity (body mass index [BMI] greater than 40)
3. Chronic renal failure
4. Creatinine clearance (CrCl) greater than 30
5. Chronic psychopathology
6. Malignancy
7. Refuse to participate
8. Fibrates treatment

Recruitment start date

25/02/2009

Recruitment end date

01/03/2011

Locations

Countries of recruitment

Spain

Trial participating centre

C/Choupana S/N
Santiago De Compostela
15706
Spain

Sponsor information

Organisation

Pescanova S.A. (Spain)

Sponsor details

Rua Jose Fernandez Lopez
S/N
Chapela
36320
Spain

Sponsor type

Industry

Website

http://www.pescanova.es/

Funders

Funder type

Industry

Funder name

Pescanova S.A. (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Biomedical Research Center in Red-Physiopathology of Obesity and Nutrition (CIBERobn) (Spain)

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

Publication citations

Additional files

Editorial Notes