Anti-inflammatory Dietary Intervention in Overweight and Obese Adolescents

NCT01665742 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2014-12-09

No results posted yet for this study

Summary

The number of overweight and obese children has increased in Ireland at a greater rate than worldwide trends. The poor eating patterns that drive adolescent obesity leads to an increase in the number of unhealthy inflammatory hormones and fats circulating in the blood which increase an adolescent's risk of developing diabetes and heart disease later in life. Dietary patterns have changed whereby key nutrients that are found in fruit, vegetables and fish, which are known to have beneficial effects and reduce risk of obesity and diabetes in later life, may need to be replaced. This project will determine whether a key anti-inflammatory nutrient supplement taken for 8 weeks will improve the metabolic profile of adolescents aged 13-18 years old. Detailed cellular analysis will determine the cellular and molecular mechanisms to provide a thorough explanation of the health effects of this intervention.

Conditions

Interventions

DIETARY_SUPPLEMENT

Supplement containing fish oil, vitamin C, alpha-tocopherol, green tea extract and lycopene

1 x fruit juice fortified with salmon oil containing 1000mg EPA and 1000mg DHA daily for 8 weeks AND 4 x film-coated tablets containing 561mg vitamin C, 389mg alpha-tocopherol, 416mg green tea extract and 15mg lycopene daily for 8 weeks in conjunction with a weight management programme

DIETARY_SUPPLEMENT

Placebo supplement

1 x fruit juice fortified fortified with high oleic sunflower oil daily for 8 weeks AND 4 x film-coated placebo tablets daily for 8 weeks in conjunction with a weight management programme

Sponsors & Collaborators

  • National Children's Research Centre, Ireland

    collaborator NETWORK
  • University of Dublin, Trinity College

    collaborator OTHER
  • The Adelaide and Meath Hospital

    collaborator OTHER
  • St. James's Hospital, Ireland

    collaborator OTHER
  • University College Dublin

    lead OTHER

Principal Investigators

  • Helen M Roche, BSc, MSc, PhD · University College Dublin

  • Fiona Lithander, BSc, PhD · University of Dublin, Trinity College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Ireland

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01665742 on ClinicalTrials.gov