NCT01758601

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
Last Updated

March 8, 2017

Status Verified

March 1, 2017

Enrollment Period

1.9 years

First QC Date

December 27, 2012

Last Update Submit

March 6, 2017

Conditions

Cardiovascular Risk FactorsMetabolic Syndrome

Keywords

white fishMetabolic syndromeCardiovascular risk

Outcome Measures

Primary Outcomes (1)

  • Serum lipids

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

    8 WEEKS

Secondary Outcomes (1)

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

    8 weeks

Other Outcomes (1)

  • Omega-3 fatty acids in random subgroup.

    8 weeks

Study Arms (2)

Fish - no fish

EXPERIMENTAL

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

No fish - fish

ACTIVE COMPARATOR

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

Interventions

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
Fish - no fishNo fish - fish
Previous alimentary habits, avoiding any significant nutritional imbalance, as well as any fish or seafoodOTHER
Fish - no fishNo fish - fish

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • We included adult patients with the metabolic syndrome as defined by the Third Report of the National Cholesterol Education Program, Adult Treatment Panel III.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Related Publications (1)

  • 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.

    PMID: 24462043DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Diet TherapySeafood

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeuticsMeatFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistance, Clinical Researcher, MD, PhD.

Study Record Dates

First Submitted

December 27, 2012

First Posted

January 1, 2013

Study Start

January 1, 2010

Primary Completion

December 1, 2011

Study Completion

November 1, 2012

Last Updated

March 8, 2017

Record last verified: 2017-03

Locations

ES(1)