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Health of Young European Families and Fish Consumption

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Landspitali University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
European Commission
University of Iceland
University College Cork
University of Navarra
The National Research Institute on Agriculture and Fisheries Research, Lisbon, Portugal
Information provided by:
Landspitali University Hospital
ClinicalTrials.gov Identifier:
NCT00315770
First received: April 18, 2006
Last updated: April 20, 2006
Last verified: April 2006
History of Changes

April 18, 2006
April 20, 2006
January 2004
Not Provided
  • Weight loss
  • Anthropometry
Same as current
Complete list of historical versions of study NCT00315770 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • Blood lipid profile (total- HDL- and 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
  • QUICKI
  • Adiponectin
  • PAI-1
  • Cortisol
  • GSH reductase
  • Malondialdehide
  • Bone specific alkaline phosphatase
  • Osteocalcin
  • PTH
  • 25-hydroxyvitamin D3 (25(OH) D3)
  • Creatinine
  • Pyridinoline (Pyr) and deoxypyridinoline (Dpyr)
  • Visual Analogue Scale for satiety
Not Provided
Not Provided
 
Health of Young European Families and Fish Consumption
Health of Young European Families and Fish Consumption

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Overweight
  • Metabolic Syndrome X
  • Bone Resorption
Procedure: weight loss diets for young adults
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
320
April 2005
Not Provided

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
Both
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00315770
FQS-506359
Not Provided
Not Provided
Landspitali University Hospital
  • European Commission
  • University of Iceland
  • University College Cork
  • University of Navarra
  • The National Research Institute on Agriculture and Fisheries Research, Lisbon, Portugal
Principal Investigator: Inga Thorsdottir, PhD LSH & HI
Landspitali University Hospital
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP