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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
Weight loss
Anthropometry
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
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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