White Fish for Cardiovascular Risk Factors in Patients With Metabolic Syndrome: the WISH-CARE Study

Madrid Health Service

Status and phase: Completed; Phase 3

Conditions: Cardiovascular Risk Factors; Metabolic Syndrome

Treatments: Other: Dietary intervention with 7 servings oh white fish per week (each serve consisted of 100g of frozen Namibia hake, Pescanova S.A., Pontevedra, Spain); Other: Previous alimentary habits, avoiding any significant nutritional imbalance, as well as any fish or seafood

Study type: Interventional

Funder types: Other

Identifiers

NCT01758601

WISH-CARE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 273 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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273 participants in 2 patient groups

Fish - no fish

Experimental group

Description:

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. Then switched to previous alimentary habits, avoiding any significant nutritional imbalance, as well as any fish or seafood.

Treatment:

Other: Dietary intervention with 7 servings oh white fish per week (each serve consisted of 100g of frozen Namibia hake, Pescanova S.A., Pontevedra, Spain)

Other: Previous alimentary habits, avoiding any significant nutritional imbalance, as well as any fish or seafood

No fish - fish

Active Comparator group

Description:

Patients were on previous diet except for the avoidance of fish and any other seafood for 8 weeks. Afterwards they were changed to the same diet but with 7 serves of hake per week.

Treatment:

Other: Dietary intervention with 7 servings oh white fish per week (each serve consisted of 100g of frozen Namibia hake, Pescanova S.A., Pontevedra, Spain)

Other: Previous alimentary habits, avoiding any significant nutritional imbalance, as well as any fish or seafood