Anti-inflammatory Dietary Intervention in Overweight and Obese Adolescents

December 5, 2014 updated by: Prof Helen M Roche, University College Dublin

Novel Anti-inflammatory Dietary Intervention to Improve the Metabolic Phenotype of Overweight and Obese 13-18 Year Old Adolescents - Insights Into Potential Genetic Susceptibility

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • University College Dublin
      • Dublin, Ireland
        • Adelaide and Meath Hospital, Incorporating the National Children's Hospital Dublin,
      • Dublin 8, Ireland
        • Trinity Centre for Health Sciences, St, James's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adiponectin
Time Frame: 8 weeks
Adiponectin, a marker of insulin sensitivity, will be determined pre- and post-intervention.
8 weeks
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
8 weeks
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
8 weeks
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
8 weeks
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Dublin

Collaborators

University of Dublin, Trinity College
St. James's Hospital, Ireland
The Adelaide and Meath Hospital
National Children's Research Centre, Ireland

Investigators

  • Principal Investigator: Helen M Roche, BSc, MSc, PhD, University College Dublin
  • Principal Investigator: Fiona Lithander, BSc, PhD, University of Dublin, Trinity College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

August 12, 2012

First Submitted That Met QC Criteria

August 12, 2012

First Posted (ESTIMATE)

August 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 5, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNS-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe