Clinical trial NCT01758601: White Fish for Cardiovascular Risk Factors in Patients With Metabolic Syndrome: the WISH-CARE Study
Official title: Estudio de intervención Nutricional Para la evaluación de Los Beneficios Sobre la Salud Derivados Del Consumo de Merluza en población Con Alto Riesgo Cardiovascular.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Risk Factors
Metabolic Syndrome
Keywords: white fish
Metabolic syndrome
Cardiovascular risk
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: CIBER de Fisiopatología de la Obesidad y Nutrición (CIBERobn).
name: Pescanova S.A., Pontevedra, Spain.
First posted: 2013-01-01
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators performed this study to evaluate the efficacy of regular ingestion of white fish to reduce cardiovascular risk factors in patients with the metabolic syndrome, compared to a diet with no fish or seafood at all.

Detailed description: This study was designed as a randomized cross-over multicenter clinical trial with participating centers from the CIBER de Fisiopatología de la Obesidad y Nutrición (CIBERobn), coordinated by the Hospital Universitario Ramón y Cajal, Madrid. The investigators included adult patients with the metabolic syndrome as defined by the Third Report of the National Cholesterol Education Program, Adult Treatment Panel III. All the subjects were Caucasian from European ancestry. Patients were randomized after the screening visit to one of two sequences: 1) Sequence 1 to receive fish consumption first and then no fish. The individuals randomized to this arm continued with their previous alimentary habits, avoiding any significant nutritional imbalance, and with an ingestion of 7 serves of hake (each serve consisted of 100g of frozen Namibia hake, Pescanova S.A., Pontevedra, Spain) per week for a period of 8 weeks. Afterwards they continued for another 8 weeks with the same diet except for the avoidance of fish and any other seafood; 2) Sequence 2 for which they started with their previous alimentary habits, avoiding any significant nutritional imbalance, as well as any fish or seafood for the first 8 weeks. Afterwards they were changed to the same diet but with 7 serves of hake per week.

Eligibility criteria: Inclusion Criteria:

* We included adult patients with the metabolic syndrome as defined by the Third Report of the National Cholesterol Education Program, Adult Treatment Panel III.

Exclusion Criteria:

* Fish allergy and positive antibodies to Anisakis spp.
* Morbid obesity with BMI ≥40kg/m2.
* Chronic renal failure.
* Chronic psychopathy.
* Neoplasia.
* Refusal to participate in the study.

Primary outcomes:
measure: Serum lipids
timeFrame: 8 WEEKS
Secondary outcomes:
measure: Other individual components of the metabolic syndrome, C-reactive protein, fatty acids, insulin-resistance.
timeFrame: 8 weeks
Other outcomes:
measure: Omega-3 fatty acids in random subgroup.
timeFrame: 8 weeks
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
References:
citation: Vazquez C, Botella-Carretero JI, Corella D, Fiol M, Lage M, Lurbe E, Richart C, Fernandez-Real JM, Fuentes F, Ordonez A, de Cos AI, Salas-Salvado J, Burguera B, Estruch R, Ros E, Pastor O, Casanueva FF; WISH-CARE Study Investigators. White fish reduces cardiovascular risk factors in patients with metabolic syndrome: the WISH-CARE study, a multicenter randomized clinical trial. Nutr Metab Cardiovasc Dis. 2014 Mar;24(3):328-35. doi: 10.1016/j.numecd.2013.09.018. Epub 2013 Nov 1.