Health of Young European Families and Fish Consumption

Phase 1

• Conditions: Overweight; Metabolic Syndrome X; Bone Resorption

• Registration Number: NCT00315770
• Lead Sponsor: Landspitali University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2006-04-18
• Study First Submitted QC: 2006-04-18
• Study First Posted: 2006-04-19
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-10
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight loss
Anthropometry

Secondary Outcome Measures

Name	Time	Method
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
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
Interleukins