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临床试验/NCT01758601
NCT01758601已完成3 期

Estudio de intervención Nutricional Para la evaluación de Los Beneficios Sobre la Salud Derivados Del Consumo de Merluza en población Con Alto Riesgo Cardiovascular.

Hospital Universitario Ramon y Cajal2 个研究点 分布在 1 个国家目标入组 273 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
273
试验地点
2
主要终点
Serum lipids

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Fish allergy and positive antibodies to Anisakis spp.
  • Morbid obesity with BMI ≥40kg/m
  • Chronic renal failure.
  • Chronic psychopathy.
  • Neoplasia.
  • Refusal to participate in the study.

结局指标

主要结局

Serum lipids

时间窗: 8 WEEKS

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

次要结局

  • Other individual components of the metabolic syndrome, C-reactive protein, fatty acids, insulin-resistance.(8 weeks)

研究者

发起方
Hospital Universitario Ramon y Cajal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose I. Botella-Carretero, MD, PhD, MBA

Clinical Assistance, Clinical Researcher, MD, PhD.

Hospital Universitario Ramon y Cajal

研究点 (2)

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