Overview

This trial is active, not recruiting.

Conditions overweight, metabolic syndrome x, bone resorption
Treatment weight loss diets for young adults
Phase phase 1
Sponsor Landspitali University Hospital
Collaborator European Commission
Start date January 2004
End date April 2005
Trial size 320 participants
Trial identifier NCT00315770, FQS-506359

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Weight loss
time frame:
Anthropometry
time frame:

Secondary Outcomes

Measure
Blood lipid profile (total high-density lipoprotein [HDL]- and low-density lipoprotein (LDL)-cholesterol, triacylglycerol)
time frame:
Fatty acid composition of red blood cells
time frame:
Fasting plasma glucose and fasting insulin
time frame:
C-reactive protein
time frame:
Prostaglandins
time frame:
Interleukins
time frame:
Intercellular adhesion molecules
time frame:
Vascular cell adhesion molecules
time frame:
Antioxidants/pro-oxidants
time frame:
Serum ghrelin
time frame:
Leptin
time frame:
Quantitative insulin-sensitivity check index (QUICKI)
time frame:
Adiponectin
time frame:
Plasminogen activator inhibitor (PAI-1)
time frame:
Cortisol
time frame:
Glutathione (GSH) reductase
time frame:
Malondialdehyde
time frame:
Bone specific alkaline phosphatase
time frame:
Osteocalcin
time frame:
Parathyroid hormone (PTH)
time frame:
25-hydroxyvitamin D3 [25(OH) D3]
time frame:
Creatinine
time frame:
Pyridinoline (Pyr) and deoxypyridinoline (Dpyr)
time frame:
Visual analogue scale for satiety
time frame:

Eligibility Criteria

Male or female participants from 20 years up to 40 years old.

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

Additional Information

Official title Health of Young European Families and Fish Consumption
Principal investigator Inga Thorsdottir, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2006.
Information provided to ClinicalTrials.gov by Landspitali University Hospital.