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Health of Young European Families and Fish Consumption

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ClinicalTrials.gov Identifier: NCT00315770
Recruitment Status : Unknown
Verified April 2006 by Landspitali University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 19, 2006
Last Update Posted : April 21, 2006
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

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.

Condition or disease Intervention/treatment Phase
Overweight Metabolic Syndrome X Bone Resorption Procedure: weight loss diets for young adults Phase 1

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 Type : Interventional  (Clinical Trial)
Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Health of Young European Families and Fish Consumption
Study Start Date : January 2004
Study Completion Date : April 2005





Primary Outcome Measures :
  1. Weight loss
  2. Anthropometry

Secondary Outcome Measures :
  1. Blood lipid profile (total high-density lipoprotein [HDL]- and low-density lipoprotein (LDL)-cholesterol, triacylglycerol)
  2. Fatty acid composition of red blood cells
  3. Fasting plasma glucose and fasting insulin
  4. C-reactive protein
  5. Prostaglandins
  6. Interleukins
  7. Intercellular adhesion molecules
  8. Vascular cell adhesion molecules
  9. Antioxidants/pro-oxidants
  10. Serum ghrelin
  11. Leptin
  12. Quantitative insulin-sensitivity check index (QUICKI)
  13. Adiponectin
  14. Plasminogen activator inhibitor (PAI-1)
  15. Cortisol
  16. Glutathione (GSH) reductase
  17. Malondialdehyde
  18. Bone specific alkaline phosphatase
  19. Osteocalcin
  20. Parathyroid hormone (PTH)
  21. 25-hydroxyvitamin D3 [25(OH) D3]
  22. Creatinine
  23. Pyridinoline (Pyr) and deoxypyridinoline (Dpyr)
  24. Visual analogue scale for satiety


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315770


Sponsors and Collaborators
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
Investigators
Principal Investigator: Inga Thorsdottir, PhD LSH & HI

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00315770     History of Changes
Other Study ID Numbers: FQS-506359
First Posted: April 19, 2006    Key Record Dates
Last Update Posted: April 21, 2006
Last Verified: April 2006

Keywords provided by Landspitali University Hospital:
overweight
Metabolic syndrome

Additional relevant MeSH terms:
Overweight
Metabolic Syndrome X
Bone Resorption
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Bone Diseases
Musculoskeletal Diseases