Text Size

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
  Purpose

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 Intervention Phase
Overweight
Metabolic Syndrome X
Bone Resorption
 Procedure: weight loss diets for young adults
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Health of Young European Families and Fish Consumption

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Landspitali University Hospital:

Primary Outcome Measures:
  • Weight loss
  • Anthropometry

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 320
Study Start Date: January 2004
Estimated Study Completion Date: April 2005
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

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Landspitali University Hospital

Additional 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
Study First Received: April 18, 2006
Last Updated: April 20, 2006
Health Authority: Iceland: Ministry of Health and Social Security

Keywords provided by Landspitali University Hospital:
overweight
Metabolic syndrome

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

ClinicalTrials.gov processed this record on June 17, 2013