Skip to main content
OpenTrials
Completed

NCT Number: NCT01758601

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Risk Factors Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

Primary outcomes

  1. Serum lipids

    Time frame: 8 WEEKS

    The primary outcome was to study the effects of hake consumption on lipid profiles, particularly on serum triglycerides.

Secondary outcomes

  1. Other individual components of the metabolic syndrome, C-reactive protein, fatty acids, insulin-resistance.

    Time frame: 8 weeks

    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.

Other outcomes

  1. Omega-3 fatty acids in random subgroup.

    Time frame: 8 weeks

    To identify specific biomarkers of white-fish consumption associated with the encountered benefits in patients with metabolic syndrome, specifically by measuring serum fatty acids.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Ramon y Cajal

Other

Collaborators

  • CIBER de Fisiopatología de la Obesidad y Nutrición (CIBERobn).
  • Pescanova S.A., Pontevedra, Spain.

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jan 1, 2013
Registry last updated
Mar 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.