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

Estudio de intervención Nutricional Para la evaluación de Los Beneficios Sobre la Salud Derivados Del Consumo de Merluza en población Con Alto Riesgo Cardiovascular.

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Cardiovascular Risk Factors
• Intervention / 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

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.

• Study Type: Interventional
• Enrollment (Actual): 273
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fish - 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. Then switched to previous alimentary habits, avoiding any significant nutritional imbalance, as well as any fish or seafood.	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
Active Comparator: No fish - fish; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum lipids	The primary outcome was to study the effects of hake consumption on lipid profiles, particularly on serum triglycerides.	8 WEEKS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other individual components of the metabolic syndrome, C-reactive protein, fatty acids, insulin-resistance.	The secondary outcomes were: the benefits on the other individual components of the metabolic syndrome, apart from lipids, as defined by the ATPIII (waist circumference, blood pressure levels, and glycemia); the effects on serum pro-inflammatory markers such as C-reactive protein, and also on insulin-resistance as calculated by the homeostasis model assessment; to identify specific biomarkers of white-fish consumption associated with the encountered benefits in patients with metabolic syndrome, specifically by measuring serum fatty acids.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Omega-3 fatty acids in random subgroup.	To identify specific biomarkers of white-fish consumption associated with the encountered benefits in patients with metabolic syndrome, specifically by measuring serum fatty acids.	8 weeks

Collaborators and Investigators

• Sponsor: Hospital Universitario Ramon y Cajal
• Collaborators: CIBER de Fisiopatología de la Obesidad y Nutrición (CIBERobn).; Pescanova S.A., Pontevedra, Spain.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: December 27, 2012
• First Submitted That Met QC Criteria: December 31, 2012
• First Posted (Estimate): January 1, 2013

Study Record Updates

• Last Update Posted (Actual): March 8, 2017
• Last Update Submitted That Met QC Criteria: March 6, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Cardiovascular risk; white fish
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: WISH-CARE