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
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