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Anti-inflammatory Dietary Intervention in Overweight and Obese Adolescents

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ClinicalTrials.gov Identifier: NCT01665742
Recruitment Status : Completed
First Posted : August 15, 2012
Last Update Posted : December 9, 2014
Information provided by (Responsible Party):

Study Description
Brief 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.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2012
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


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


4 x film-coated placebo tablets daily for 8 weeks

in conjunction with a weight management programme

Outcome Measures

Primary Outcome Measures :
  1. Homeostasis model of assessment - insulin resistance [ Time Frame: 8 weeks ]
    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 :
  1. Adiponectin [ Time Frame: 8 weeks ]
    Adiponectin, a marker of insulin sensitivity, will be determined pre- and post-intervention.

  2. Markers of inflammation [ Time Frame: 8 weeks ]
    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

  3. Lipid Profile [ Time Frame: 8 weeks ]
    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

  4. Inflammatory genetic variants [ Time Frame: 8 weeks ]
    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

  5. Functional molecular analysis (ex-vivo) [ Time Frame: 8 weeks ]
    Functional molecular analysis will be conducted to determine which insulin sensitising pathways have been modulated by the intervention

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665742

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

Responsible Party: Prof Helen M Roche, Associate Professor of Nutrigenomics, University College Dublin
ClinicalTrials.gov Identifier: NCT01665742     History of Changes
Other Study ID Numbers: TNS-5
First Posted: August 15, 2012    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

Keywords provided by Prof Helen M Roche, University College Dublin:
Chronic inflammation
Anti-inflammatory dietary intervention
Genetic susceptibility

Additional relevant MeSH terms:
Genetic Predisposition to Disease
Body Weight
Signs and Symptoms
Disease Susceptibility
Disease Attributes
Pathologic Processes
Ascorbic Acid
Vitamin E
Anti-Inflammatory Agents
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents