Health of Young European Families and Fish Consumption

Study Overview
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Brief Summary
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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.

Detailed Description
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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) Risk factors for metabolic syndrome, bone health and weight management were analysed at baseline and endpoint.

Official Title
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Health of Young European Families and Fish Consumption

Conditions
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Overweight, Metabolic Syndrome X, Bone Resorption

Intervention / Treatment
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* Procedure: weight loss diets for young adults


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: weight loss diets for young adults|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  |  | 
| Anthropometry |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipid profile (total high-density lipoprotein [HDL]- and low-density lipoprotein (LDL)-cholesterol, triacylglycerol) |  |  | 
| Fatty acid composition of red blood cells |  |  | 
| Fasting plasma glucose and fasting insulin |  |  | 
| C-reactive protein |  |  | 
| Prostaglandins |  |  | 
| Interleukins |  |  | 
| Intercellular adhesion molecules |  |  | 
| Vascular cell adhesion molecules |  |  | 
| Antioxidants/pro-oxidants |  |  | 
| Serum ghrelin |  |  | 
| Leptin |  |  | 
| Quantitative insulin-sensitivity check index (QUICKI) |  |  | 
| Adiponectin |  |  | 
| Plasminogen activator inhibitor (PAI-1) |  |  | 
| Cortisol |  |  | 
| Glutathione (GSH) reductase |  |  | 
| Malondialdehyde |  |  | 
| Bone specific alkaline phosphatase |  |  | 
| Osteocalcin |  |  | 
| Parathyroid hormone (PTH) |  |  | 
| 25-hydroxyvitamin D3 [25(OH) D3] |  |  | 
| Creatinine |  |  | 
| Pyridinoline (Pyr) and deoxypyridinoline (Dpyr) |  |  | 
| Visual analogue scale for satiety |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight, Metabolic syndrome