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
About this trial
This is an interventional treatment trial for Overweight focused on measuring overweight, Metabolic syndrome
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
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
NCT ID
NCT00315770
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
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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