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Health of Young European Families and Fish Consumption

L

Landspítali – National University Hospital of Iceland

Status and phase

Unknown
Phase 1

Conditions

Overweight
Metabolic Syndrome X
Bone Resorption

Treatments

Procedure: weight loss diets for young adults

Study type

Interventional

Funder types

Other

Identifiers

NCT00315770
FQS-506359

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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