This trial is active, not recruiting.

Conditions overweight, metabolic syndrome x, bone resorption
Treatment weight loss diets for young adults
Phase phase 1
Sponsor Landspitali University Hospital
Collaborator European Commission
Start date January 2004
End date April 2005
Trial size 320 participants
Trial identifier NCT00315770, FQS-506359


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Weight loss
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Secondary Outcomes

Blood lipid profile (total high-density lipoprotein [HDL]- and low-density lipoprotein (LDL)-cholesterol, triacylglycerol)
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Fatty acid composition of red blood cells
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Fasting plasma glucose and fasting insulin
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C-reactive protein
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Intercellular adhesion molecules
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Vascular cell adhesion molecules
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Serum ghrelin
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Quantitative insulin-sensitivity check index (QUICKI)
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Plasminogen activator inhibitor (PAI-1)
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Glutathione (GSH) reductase
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Bone specific alkaline phosphatase
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Parathyroid hormone (PTH)
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25-hydroxyvitamin D3 [25(OH) D3]
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Pyridinoline (Pyr) and deoxypyridinoline (Dpyr)
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Visual analogue scale for satiety
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Eligibility Criteria

Male or female participants from 20 years up to 40 years old.

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

Additional Information

Official title Health of Young European Families and Fish Consumption
Principal investigator Inga Thorsdottir, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2006.
Information provided to ClinicalTrials.gov by Landspitali University Hospital.