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OverweightPhase 1NCT00315770

Health of Young European Families and Fish Consumption

A Phase 1 study testing weight loss diets for young adults in people with Overweight and Metabolic Syndrome X, run by Landspitali University Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Overweight, Metabolic Syndrome X, Bone Resorption
What is being tested?
weight loss diets for young adults
Type of treatment
Surgery or procedure
How many people
320 participants
Where
No sites listed yet
Study dates
Jan 2004to Apr 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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.

Read the 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.

Being tested
weight loss diets for young adults
Keywords
overweight, Metabolic syndrome
Medical subject headings
Overweight, Metabolic Syndrome, Bone Resorption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • weight loss diets for young adultsProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight loss

  2. Anthropometry

Secondary outcomes (24)

  1. Blood lipid profile (total high-density lipoprotein [HDL]- and low-density lipoprotein (LDL)-cholesterol, triacylglycerol)

  2. Fatty acid composition of red blood cells

  3. Fasting plasma glucose and fasting insulin

  4. C-reactive protein

  5. Prostaglandins

  6. Interleukins

  7. Intercellular adhesion molecules

  8. Vascular cell adhesion molecules

  9. Antioxidants/pro-oxidants

  10. Serum ghrelin

  11. Leptin

  12. Quantitative insulin-sensitivity check index (QUICKI)

  13. Adiponectin

  14. Plasminogen activator inhibitor (PAI-1)

  15. Cortisol

  16. Glutathione (GSH) reductase

  17. Malondialdehyde

  18. Bone specific alkaline phosphatase

  19. Osteocalcin

  20. Parathyroid hormone (PTH)

  21. 25-hydroxyvitamin D3 [25(OH) D3]

  22. Creatinine

  23. Pyridinoline (Pyr) and deoxypyridinoline (Dpyr)

  24. Visual analogue scale for satiety

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2006 (estimated)
  2. Study startJan 2004
  3. Study completionApr 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
320 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00315770
Sponsor's protocol ID
FQS-506359
Status last verified
Aug 2018
First submitted
18 Apr 2006
Last updated
10 Aug 2018
Results posted
No

Publications

  • 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.

    PubMed 23361157

  • 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.

    PubMed 20551965

  • 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.

    PubMed 19487105

  • 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.

    PubMed 19142567

  • 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.

    PubMed 18491071

  • 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.

    PubMed 18400730

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing weight loss diets for young adults in people with Overweight and Metabolic Syndrome X, run by Landspitali University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight loss. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00315770, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.

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