Clinical trial NCT00315770: Health of Young European Families and Fish Consumption
Official title: Health of Young European Families and Fish Consumption
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Overweight
Metabolic Syndrome X
Bone Resorption
Keywords: overweight
Metabolic syndrome
Lead sponsor: Landspitali University Hospital
Sponsor class: OTHER
Collaborators: name: European Commission
name: University of Iceland
name: University College Cork
name: University of Navarra
name: The National Research Institute on Agriculture and Fisheries Research, Lisbon, Portugal
First posted: 2006-04-19
Enrollment: 320
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight loss
measure: Anthropometry
Secondary outcomes:
measure: Blood lipid profile (total high-density lipoprotein [HDL]- and low-density lipoprotein (LDL)-cholesterol, triacylglycerol)
measure: Fatty acid composition of red blood cells
measure: Fasting plasma glucose and fasting insulin
measure: C-reactive protein
measure: Prostaglandins
measure: Interleukins
measure: Intercellular adhesion molecules
measure: Vascular cell adhesion molecules
measure: Antioxidants/pro-oxidants
measure: Serum ghrelin
measure: Leptin
measure: Quantitative insulin-sensitivity check index (QUICKI)
measure: Adiponectin
measure: Plasminogen activator inhibitor (PAI-1)
measure: Cortisol
measure: Glutathione (GSH) reductase
measure: Malondialdehyde
measure: Bone specific alkaline phosphatase
measure: Osteocalcin
measure: Parathyroid hormone (PTH)
measure: 25-hydroxyvitamin D3 [25(OH) D3]
measure: Creatinine
measure: Pyridinoline (Pyr) and deoxypyridinoline (Dpyr)
measure: Visual analogue scale for satiety
Other outcomes:
Locations:
Study officials:
affiliation: LSH & HI
name: Inga Thorsdottir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramel A, Halldorsson TI, Tryggvadottir EA, Martinez JA, Kiely M, Bandarra NM, Thorsdottir I. Relationship between BMI and body fatness in three European countries. Eur J Clin Nutr. 2013 Mar;67(3):254-8. doi: 10.1038/ejcn.2013.6. Epub 2013 Jan 30.
citation: Ramel A, Martinez JA, Kiely M, Bandarra NM, Thorsdottir I. Effects of weight loss and seafood consumption on inflammation parameters in young, overweight and obese European men and women during 8 weeks of energy restriction. Eur J Clin Nutr. 2010 Sep;64(9):987-93. doi: 10.1038/ejcn.2010.99. Epub 2010 Jun 16.
citation: Ramel A, Martinez JA, Kiely M, Bandarra NM, Thorsdottir I. Moderate consumption of fatty fish reduces diastolic blood pressure in overweight and obese European young adults during energy restriction. Nutrition. 2010 Feb;26(2):168-74. doi: 10.1016/j.nut.2009.04.002. Epub 2009 May 31.
citation: Ramel A, Parra D, Martinez JA, Kiely M, Thorsdottir I. Effects of seafood consumption and weight loss on fasting leptin and ghrelin concentrations in overweight and obese European young adults. Eur J Nutr. 2009 Mar;48(2):107-14. doi: 10.1007/s00394-008-0769-9. Epub 2009 Jan 13.
citation: Ramel A, Martinez A, Kiely M, Morais G, Bandarra NM, Thorsdottir I. Beneficial effects of long-chain n-3 fatty acids included in an energy-restricted diet on insulin resistance in overweight and obese European young adults. Diabetologia. 2008 Jul;51(7):1261-8. doi: 10.1007/s00125-008-1035-7. Epub 2008 May 20.
citation: Lucey AJ, Paschos GK, Cashman KD, Martinez JA, Thorsdottir I, Kiely M. Influence of moderate energy restriction and seafood consumption on bone turnover in overweight young adults. Am J Clin Nutr. 2008 Apr;87(4):1045-52. doi: 10.1093/ajcn/87.4.1045.