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

Metabolic Syndrome Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01758601
• Other study ID #: WISH-CARE
• Status: Completed
• Phase: Phase 3
• First received: December 27, 2012
• Last updated: March 6, 2017
• Start date: January 2010
• Est. completion date: November 2012

Study information

• Verified date: March 2017
• Source: Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: November 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factors
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

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)

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

Locations

Country	Name	City	State
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitario Ramon y Cajal	CIBER de Fisiopatología de la Obesidad y Nutrición (CIBERobn)., Pescanova S.A., Pontevedra, Spain.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Serum lipids	The primary outcome was to study the effects of hake consumption on lipid profiles, particularly on serum triglycerides.	8 WEEKS
Secondary	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