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Anti-inflammatory Dietary Intervention in Overweight and Obese Adolescents

This study is currently recruiting participants.
Verified September 2012 by University College Dublin
Sponsor:
Collaborators:
National Children's Research Centre, Ireland
University of Dublin, Trinity College
The Adelaide and Meath Hospital
St. James's Hospital, Ireland
Information provided by (Responsible Party):
Dr Helen M Roche, University College Dublin
ClinicalTrials.gov Identifier:
NCT01665742
First received: August 12, 2012
Last updated: September 17, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Overweight
Obesity
 Dietary Supplement: Supplement containing fish oil, vitamin C, alpha-tocopherol, green tea extract and lycopene
Dietary Supplement: Placebo supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Novel Anti-inflammatory Dietary Intervention to Improve the Metabolic Phenotype of Overweight and Obese 13-18 Year Old Adolescents - Insights Into Potential Genetic Susceptibility

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University College Dublin:

Primary Outcome Measures:
  • Homeostasis model of assessment - insulin resistance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Homeostasis model of assessment - insulin resistance (HOMA-IR) will be derived from fasting glucose and insulin concentrations [(fasting plasma glucose x fasting serum insulin)/22.5] as determined by Matthews et al., 1985


Secondary Outcome Measures:
  • Adiponectin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Adiponectin, a marker of insulin sensitivity, will be determined pre- and post-intervention.

  • Markers of inflammation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Markers of inflammation such as C reactive protein, interleukin (IL) - 6, IL-1β, tumour necrosis factor alpha, intra-cellular adhesion molecule-1, vascular cell adhesion molecule-1, retinol binding protein 4, fibrinogen, white blood cells and related inflammatory markers

  • Lipid Profile [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Full lipid profile and lipidomic analyses (total triacylglycerol, non-esterified fatty acids, total cholesterol, LDL cholesterol, HDL cholesterol and plasma fatty acid composition, diglycerides, cholesterol esters and sphingomyelins,) and related lipid markers

  • Inflammatory genetic variants [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Inflammatory genetic variants such as complement component 3, lymphotoxin- α, IL-6, IL-1β, TNF-α, adiponectin polymorphisms and related variants that link to the inflammatory phenotype

  • Functional molecular analysis (ex-vivo) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Functional molecular analysis will be conducted to determine which insulin sensitising pathways have been modulated by the intervention


Estimated Enrollment: 90
Study Start Date: January 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anti-inflammatory supplement

8-weeks of daily supplementation with:

1 x fruit juice fortified with fish oil, and 4 x film-coated tablets containing vitamin C, alpha-tocopherol, green tea extract and lycopene

in conjunction with a weight management programme

 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
Placebo Comparator: Placebo supplement

8 weeks of daily supplementation with:

1 x fruit juice fortified with high-oleic sunflower oil, and 4 x film-coated placebo tablets

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

Detailed Description:

The emerging model of obesity and diabetes is characterised by sub-acute chronic inflammation and insulin resistance. Mechanistic data indicates inflamed adipose tissue with increased infiltration of immune cells that generate pro-inflammatory cytokines. With childhood obesity in Ireland increasing at a rapid pace, it is important to establish the role of a non-pharmacological dietary approach to decreasing the sub-acute chronic inflammation seen in overweight and obese children. Several foods contain nutrients that are known to have anti-inflammatory properties. Such foods including fish, fruits and vegetables are known to be deplete in the adolescent diet. The aim of this project is to investigate whether a nutritional supplement containing anti-inflammatory nutrients, n-3 polyunsaturated fatty acids (found in fish oil), vitamin C, vitamin E, and polyphenols found in green tea and tomato; will improve metabolic phenotype in 13-18 year old teenagers over an 8-week period. Further, to provide insight into the role of genetics in the development of metabolic dysregulation and response to dietary treatment.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female
  2. 13-18 years
  3. Body mass index ≥ 91st percentile on UK growth reference charts (Cole, 1995)
  4. Medications/dietary supplements which do not interfere with the intervention are allowed, on condition that the participants adhere to the same regimen during the intervention, including oral contraceptives and other non-fatty acid based dietary supplements (e.g. garlic)
  5. Smoker or non-smoker
  6. Not participating in any other intervention study

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Endocrine disorders such as Polycystic Ovary Syndrome
  3. Currently on treatment for a chronic inflammatory condition such as asthma
  4. Kidney or liver dysfunction
  5. Iron deficiency anaemia
  6. Prescribed anti-inflammatory medication
  7. Consumers of fatty acid supplements including fish oils, evening primrose oil and antioxidant vitamin (A, C, E, -carotene) supplements
  8. High consumers of oily fish (> 2 servings/week)
  9. Participants planning to start a special diet or lose weight (e.g. Slimfast, Atkins etc)
  10. Weight change ≥3kg within the last 3 months
  11. Alcohol or drug abuse (based on clinical judgement)
  12. Participants with an allergy to fish and/or shellfish
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665742

Contacts
Contact: Helen M Roche, BSc, MSc, PhD +353-1-7166845 helen.roche@ucd.ie

Locations
Ireland
University College Dublin Recruiting
Dublin, Ireland
Adelaide and Meath Hospital, Incorporating the National Children's Hospital Dublin, Recruiting
Dublin, Ireland
Trinity Centre for Health Sciences, St, James's Hospital Completed
Dublin 8, Ireland
Sponsors and Collaborators
University College Dublin
National Children's Research Centre, Ireland
University of Dublin, Trinity College
The Adelaide and Meath Hospital
St. James's Hospital, Ireland
Investigators
Principal Investigator: Helen M Roche, BSc, MSc, PhD University College Dublin
Principal Investigator: Fiona Lithander, BSc, PhD University of Dublin, Trinity College
  More Information

No publications provided

Responsible Party: Dr Helen M Roche, Associate Professor of Nutrigenomics, University College Dublin
ClinicalTrials.gov Identifier: NCT01665742     History of Changes
Other Study ID Numbers: TNS-5
Study First Received: August 12, 2012
Last Updated: September 17, 2012
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University College Dublin:
Obesity
Chronic inflammation
Anti-inflammatory dietary intervention
Genetic susceptibility

Additional relevant MeSH terms:
Disease Susceptibility
Genetic Predisposition to Disease
Obesity
Overweight
Disease Attributes
Pathologic Processes
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Anti-Inflammatory Agents
Ascorbic Acid
Alpha-Tocopherol
Vitamin E
Lycopene
 Tocopherols
Tocotrienols
Vitamins
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013