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

This study has been completed.
Sponsor:
Collaborators:
CIBER de Fisiopatología de la Obesidad y Nutrición (CIBERobn).
Pescanova S.A., Pontevedra, Spain.
Information provided by (Responsible Party):
Jose I. Botella-Carretero, MD, PhD, MBA, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT01758601
First received: December 27, 2012
Last updated: December 31, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cardiovascular Risk Factors.
Metabolic Syndrome.
 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
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Universitario Ramon y Cajal:

Primary Outcome Measures:
  • Serum lipids [ Time Frame: 8 WEEKS ] [ Designated as safety issue: No ]
    The primary outcome was to study the effects of hake consumption on lipid profiles, particularly on serum triglycerides.


Secondary Outcome Measures:
  • Other individual components of the metabolic syndrome, C-reactive protein, fatty acids, insulin-resistance. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Omega-3 fatty acids in random subgroup. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    To identify specific biomarkers of white-fish consumption associated with the encountered benefits in patients with metabolic syndrome, specifically by measuring serum fatty acids.


Enrollment: 273
Study Start Date: January 2010
Study Completion Date: November 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758601

Locations
Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Sponsors and Collaborators
Hospital Universitario Ramon y Cajal
CIBER de Fisiopatología de la Obesidad y Nutrición (CIBERobn).
Pescanova S.A., Pontevedra, Spain.
  More Information

No publications provided

Responsible Party: Jose I. Botella-Carretero, MD, PhD, MBA, Clinical Assistance, Clinical Researcher, MD, PhD., Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT01758601     History of Changes
Other Study ID Numbers: WISH-CARE
Study First Received: December 27, 2012
Last Updated: December 31, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitario Ramon y Cajal:
white fish
Metabolic syndrome
Cardiovascular risk

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013