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

Primary Purpose

Cardiovascular Risk Factors, Metabolic Syndrome

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
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
Sponsored by
Hospital Universitario Ramon y Cajal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Risk Factors focused on measuring white fish, Metabolic syndrome, Cardiovascular risk

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Universitario Ramón y Cajal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fish - no fish

No fish - fish

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Serum lipids
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.
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.

Full Information

First Posted
December 27, 2012
Last Updated
March 6, 2017
Sponsor
Hospital Universitario Ramon y Cajal
Collaborators
CIBER de Fisiopatología de la Obesidad y Nutrición (CIBERobn)., Pescanova S.A., Pontevedra, Spain.
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1. Study Identification

Unique Protocol Identification Number
NCT01758601
Brief Title
White Fish for Cardiovascular Risk Factors in Patients With Metabolic Syndrome: the WISH-CARE Study
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Ramon y Cajal
Collaborators
CIBER de Fisiopatología de la Obesidad y Nutrición (CIBERobn)., Pescanova S.A., Pontevedra, Spain.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factors, Metabolic Syndrome
Keywords
white fish, Metabolic syndrome, Cardiovascular risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
273 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fish - no fish
Arm Type
Experimental
Arm Description
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.
Arm Title
No fish - fish
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dietary intervention with 7 servings oh white fish per week (each serve consisted of 100g of frozen Namibia hake, Pescanova S.A., Pontevedra, Spain)
Intervention Type
Other
Intervention Name(s)
Previous alimentary habits, avoiding any significant nutritional imbalance, as well as any fish or seafood
Primary Outcome Measure Information:
Title
Serum lipids
Description
The primary outcome was to study the effects of hake consumption on lipid profiles, particularly on serum triglycerides.
Time Frame
8 WEEKS
Secondary Outcome Measure Information:
Title
Other individual components of the metabolic syndrome, C-reactive protein, fatty acids, insulin-resistance.
Description
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.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Omega-3 fatty acids in random subgroup.
Description
To identify specific biomarkers of white-fish consumption associated with the encountered benefits in patients with metabolic syndrome, specifically by measuring serum fatty acids.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24462043
Citation
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.
Results Reference
derived

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

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