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Health of Young European Families and Fish Consumption

Health of Young European Families and Fish Consumption

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00315770
Enrollment
320
Registered
2006-04-19
Start date
2004-01-31
Completion date
2020-04-30
Last updated
2018-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Resorption, Metabolic Syndrome X, Overweight

Keywords

overweight, Metabolic syndrome

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.

Interventions

PROCEDUREweight loss diets for young adults

Sponsors

European Commission
CollaboratorOTHER
University of Iceland
CollaboratorOTHER
University College Cork
CollaboratorOTHER
University of Navarra
CollaboratorOTHER
The National Research Institute on Agriculture and Fisheries Research, Lisbon, Portugal
CollaboratorOTHER
Landspitali University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Weight loss
Anthropometry

Secondary

MeasureTime frame
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
Blood lipid profile (total high-density lipoprotein [HDL]- and low-density lipoprotein (LDL)-cholesterol, triacylglycerol)
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
Plasminogen activator inhibitor (PAI-1)
Fatty acid composition of red blood cells

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026