Effect of Fish Oil on Markers of the Metabolic Syndrome in Overweight Adolescent Boys

NCT00929552 | Completed

• 2 other identifiers: D202H-A-2007-0055
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate if dietary fish oil has a beneficial effect on blood pressure, insulin sensitivity, blood lipid profile, body composition and metabolic rate in healthy, but slightly overweight, teenage boys. We hypothesized that the n-3 long chain polyunsaturated fatty acids from fish oil might have greater effect during growth and development, as intervention trials studying the effect of fish oil on babies have shown greater effects than in adults.

Conditions

Metabolic Syndrome

Keywords

Blood pressure; Insulin sensitivity; Blood lipid profile

Outcome Measures

Primary Outcomes (1)

• Markers of the metabolic syndrome. Blood pressure, insulin sensitivity, HDL-cholesterol and triacylglycerol.

  Intervention period = 16 weeks

Secondary Outcomes (1)

• Body composition

  16 weeks

Study Arms (2)

Fish oil

EXPERIMENTAL

Daily dose = 6g fish oil baked into rye bread and wheat rolls. Participants were asked to consume two slices of rye bread and one wheat roll pr day. The fish oil was micro-incapsulated.

Dietary Supplement: Dietary oils (fish, vegetable oil)

Vegetable oil (Mix of canola, palm and soy oil)

ACTIVE COMPARATOR

Daily dose = 6g vegetable oil baked into rye bread and wheat rolls. Participants were asked to consume two slices of rye bread and one wheat roll pr day.

Dietary Supplement: Dietary oils (fish, vegetable oil)

Interventions

Dietary oils (fish, vegetable oil) DIETARY_SUPPLEMENT

6g pr day.

Fish oil; Vegetable oil (Mix of canola, palm and soy oil)

Eligibility Criteria

• Age: 13 Years - 15 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Weight above the 90th percentile for height and age.

You may not qualify if:

• Smoking, severe illnesses.

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Department of Human Nutrition

Frederiksberg, 1958, Denmark

Location

Related Publications (1)

• Pedersen MH, Molgaard C, Hellgren LI, Lauritzen L. Effects of fish oil supplementation on markers of the metabolic syndrome. J Pediatr. 2010 Sep;157(3):395-400, 400.e1. doi: 10.1016/j.jpeds.2010.04.001. Epub 2010 May 15.

  PMID: 20472253 RESULT

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Interventions

Dietary Fats, Unsaturated; In Situ Hybridization, Fluorescence; Plant Oils

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats; Fats; Lipids; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Lotte Lauritzen, Ph.D.

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 26, 2009
• First Posted: June 29, 2009
• Study Start: November 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2009
• Last Updated: September 26, 2012

Record last verified: 2012-09

Locations

DK (1)