Health of Young European Families and Fish Consumption
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 320
- 主要终点
- Weight loss
研究概览
简要总结
This is a controlled, randomized, intervention trial (CRIT) with 20-40 year old overweight individuals (n = 320) across Europe in order to distinguish between biologically active components of seafood, i.e., seafood proteins and n-3 lipids, regarding their effects on risk factors for metabolic syndrome, bone health, and weight management.
详细描述
Subjects were recruited through advertisements from October 2004 until April 2005. Recruitment of 320 subjects (140 from Iceland, 120 from Spain, and 60 from Ireland). The inclusion criteria were body mass index (BMI) 27.5 to 32.5 kg/m2, age 20-40 years, and a waist circumference of equal or more than 94 cm and 80 cm for men and women, respectively. Exclusion criteria were weight change due to weight loss diet within 3 months before the start of the study, use of supplements giving n-3 fatty acids, calcium or vitamin-D during the last three months, drug treatment of diabetes mellitus, hypertension or hyperlipidemia and women's pregnancy or lactation. Each subject was instructed to follow a diet, energy-restricted by 30% from estimated energy expenditure (approximately 600 kcal/day), for 8 consecutive weeks. The subjects were randomly assigned to four diets varying in types of dietary protein and amount of n-3 fatty acids (especially very long chain n-3 fatty acids):
I: no seafood (control, including 6 placebo capsules/day)
II: lean fish (150 g cod x 3/week)
III: fatty fish (150 g salmon x 3/week)
IV: fish-oil capsules (6 capsules/day)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) of 27.5 to 32.5 kg/m2
- •Ages 20-40 years
- •Waist circumference of equal or more than 94 cm and 80 cm for men and women, respectively
排除标准
- •Weight change due to weight loss diet within 3 months before the start of the study
- •Use of supplements giving n-3 fatty acids
- •Calcium or vitamin D during the last three months
- •Drug treatment for diabetes mellitus
- •Hypertension or hyperlipidemia
- •Women's pregnancy or lactation
结局指标
主要结局
Weight loss
Anthropometry
次要结局
- Prostaglandins
- Intercellular adhesion molecules
- Vascular cell adhesion molecules
- Blood lipid profile (total high-density lipoprotein [HDL]- and low-density lipoprotein (LDL)-cholesterol, triacylglycerol)
- Fasting plasma glucose and fasting insulin
- Cortisol
- Osteocalcin
- Pyridinoline (Pyr) and deoxypyridinoline (Dpyr)
- Visual analogue scale for satiety
- Fatty acid composition of red blood cells
- Interleukins
- Quantitative insulin-sensitivity check index (QUICKI)
- Antioxidants/pro-oxidants
- Leptin
- Adiponectin
- Plasminogen activator inhibitor (PAI-1)
- Parathyroid hormone (PTH)
- 25-hydroxyvitamin D3 [25(OH) D3]
- Creatinine
- C-reactive protein
- Serum ghrelin
- Glutathione (GSH) reductase
- Malondialdehyde
- Bone specific alkaline phosphatase