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

Sponsor

Hospital Universitario Ramon y Cajal (Other)

Overall Status

Completed

CT.gov ID

NCT01758601

Collaborator

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

273

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	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

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 Design

Study Type:

Interventional

Actual Enrollment :

273 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (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.

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Serum lipids [8 WEEKS]
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. [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 Outcome Measures

Omega-3 fatty acids in random subgroup. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None 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

Other Study ID Numbers:

WISH-CARE

First Posted:

Jan 1, 2013

Last Update Posted:

Mar 8, 2017

Last Verified:

Mar 1, 2017

Keywords provided by Jose I. Botella-Carretero, MD, PhD, MBA, Clinical Assistance, Clinical Researcher, MD, PhD., Hospital Universitario Ramon y Cajal

white fish

Metabolic syndrome

Cardiovascular risk

Additional relevant MeSH terms:

Metabolic Syndrome

Syndrome

Study Results

No Results Posted as of Mar 8, 2017