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Health of Young European Families and Fish Consumption

Primary Purpose

Overweight, Metabolic Syndrome X, Bone Resorption

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
weight loss diets for young adults
Sponsored by
Landspitali University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring overweight, Metabolic syndrome

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts 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

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    April 18, 2006
    Last Updated
    August 9, 2018
    Sponsor
    Landspitali University Hospital
    Collaborators
    European Commission, University of Iceland, University College Cork, University of Navarra, The National Research Institute on Agriculture and Fisheries Research, Lisbon, Portugal
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00315770
    Brief Title
    Health of Young European Families and Fish Consumption
    Official Title
    Health of Young European Families and Fish Consumption
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2020 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Landspitali University Hospital
    Collaborators
    European Commission, University of Iceland, University College Cork, University of Navarra, The National Research Institute on Agriculture and Fisheries Research, Lisbon, Portugal

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight, Metabolic Syndrome X, Bone Resorption
    Keywords
    overweight, Metabolic syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    320 (false)

    8. Arms, Groups, and Interventions

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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Inga Thorsdottir, PhD
    Organizational Affiliation
    LSH & HI
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23361157
    Citation
    Ramel A, Halldorsson TI, Tryggvadottir EA, Martinez JA, Kiely M, Bandarra NM, Thorsdottir I. Relationship between BMI and body fatness in three European countries. Eur J Clin Nutr. 2013 Mar;67(3):254-8. doi: 10.1038/ejcn.2013.6. Epub 2013 Jan 30.
    Results Reference
    derived
    PubMed Identifier
    20551965
    Citation
    Ramel A, Martinez JA, Kiely M, Bandarra NM, Thorsdottir I. Effects of weight loss and seafood consumption on inflammation parameters in young, overweight and obese European men and women during 8 weeks of energy restriction. Eur J Clin Nutr. 2010 Sep;64(9):987-93. doi: 10.1038/ejcn.2010.99. Epub 2010 Jun 16.
    Results Reference
    derived
    PubMed Identifier
    19487105
    Citation
    Ramel A, Martinez JA, Kiely M, Bandarra NM, Thorsdottir I. Moderate consumption of fatty fish reduces diastolic blood pressure in overweight and obese European young adults during energy restriction. Nutrition. 2010 Feb;26(2):168-74. doi: 10.1016/j.nut.2009.04.002. Epub 2009 May 31.
    Results Reference
    derived
    PubMed Identifier
    19142567
    Citation
    Ramel A, Parra D, Martinez JA, Kiely M, Thorsdottir I. Effects of seafood consumption and weight loss on fasting leptin and ghrelin concentrations in overweight and obese European young adults. Eur J Nutr. 2009 Mar;48(2):107-14. doi: 10.1007/s00394-008-0769-9. Epub 2009 Jan 13.
    Results Reference
    derived
    PubMed Identifier
    18491071
    Citation
    Ramel A, Martinez A, Kiely M, Morais G, Bandarra NM, Thorsdottir I. Beneficial effects of long-chain n-3 fatty acids included in an energy-restricted diet on insulin resistance in overweight and obese European young adults. Diabetologia. 2008 Jul;51(7):1261-8. doi: 10.1007/s00125-008-1035-7. Epub 2008 May 20.
    Results Reference
    derived
    PubMed Identifier
    18400730
    Citation
    Lucey AJ, Paschos GK, Cashman KD, Martinez JA, Thorsdottir I, Kiely M. Influence of moderate energy restriction and seafood consumption on bone turnover in overweight young adults. Am J Clin Nutr. 2008 Apr;87(4):1045-52. doi: 10.1093/ajcn/87.4.1045.
    Results Reference
    derived

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    Health of Young European Families and Fish Consumption

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