search
Back to results

Anti-inflammatory Dietary Intervention in Overweight and Obese Adolescents

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Supplement containing fish oil, vitamin C, alpha-tocopherol, green tea extract and lycopene
Placebo supplement
Sponsored by
University College Dublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Obesity, Chronic inflammation, Anti-inflammatory dietary intervention, Genetic susceptibility

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Anti-inflammatory supplement

Placebo supplement

Arm Description

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

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

Outcomes

Primary Outcome Measures

Homeostasis model of assessment - insulin resistance
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
Adiponectin, a marker of insulin sensitivity, will be determined pre- and post-intervention.
Markers of inflammation
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
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
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)
Functional molecular analysis will be conducted to determine which insulin sensitising pathways have been modulated by the intervention

Full Information

First Posted
August 12, 2012
Last Updated
December 5, 2014
Sponsor
University College Dublin
Collaborators
National Children's Research Centre, Ireland, University of Dublin, Trinity College, The Adelaide and Meath Hospital, St. James's Hospital, Ireland
search

1. Study Identification

Unique Protocol Identification Number
NCT01665742
Brief Title
Anti-inflammatory Dietary Intervention in Overweight and Obese Adolescents
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Dublin
Collaborators
National Children's Research Centre, Ireland, University of Dublin, Trinity College, The Adelaide and Meath Hospital, St. James's Hospital, Ireland

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Obesity, Chronic inflammation, Anti-inflammatory dietary intervention, Genetic susceptibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anti-inflammatory supplement
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo supplement
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Supplement containing fish oil, vitamin C, alpha-tocopherol, green tea extract and lycopene
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo supplement
Intervention Description
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
Primary Outcome Measure Information:
Title
Homeostasis model of assessment - insulin resistance
Description
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Adiponectin
Description
Adiponectin, a marker of insulin sensitivity, will be determined pre- and post-intervention.
Time Frame
8 weeks
Title
Markers of inflammation
Description
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
Time Frame
8 weeks
Title
Lipid Profile
Description
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
Time Frame
8 weeks
Title
Inflammatory genetic variants
Description
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
Time Frame
8 weeks
Title
Functional molecular analysis (ex-vivo)
Description
Functional molecular analysis will be conducted to determine which insulin sensitising pathways have been modulated by the intervention
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female 13-18 years Body mass index ≥ 91st percentile on UK growth reference charts (Cole, 1995) 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) Smoker or non-smoker Not participating in any other intervention study Exclusion Criteria: Pregnancy or lactation Endocrine disorders such as Polycystic Ovary Syndrome Currently on treatment for a chronic inflammatory condition such as asthma Kidney or liver dysfunction Iron deficiency anaemia Prescribed anti-inflammatory medication Consumers of fatty acid supplements including fish oils, evening primrose oil and antioxidant vitamin (A, C, E, -carotene) supplements High consumers of oily fish (> 2 servings/week) Participants planning to start a special diet or lose weight (e.g. Slimfast, Atkins etc) Weight change ≥3kg within the last 3 months Alcohol or drug abuse (based on clinical judgement) Participants with an allergy to fish and/or shellfish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen M Roche, BSc, MSc, PhD
Organizational Affiliation
University College Dublin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fiona Lithander, BSc, PhD
Organizational Affiliation
University of Dublin, Trinity College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trinity Centre for Health Sciences, St, James's Hospital
City
Dublin 8
Country
Ireland
Facility Name
Adelaide and Meath Hospital, Incorporating the National Children's Hospital Dublin,
City
Dublin
Country
Ireland
Facility Name
University College Dublin
City
Dublin
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29665620
Citation
McMorrow AM, Connaughton RM, Magalhaes TR, McGillicuddy FC, Hughes MF, Cheishvili D, Morine MJ, Ennis S, Healy ML, Roche EF, Tremblay RE, Szyf M, Lithander FE, Roche HM. Personalized Cardio-Metabolic Responses to an Anti-Inflammatory Nutrition Intervention in Obese Adolescents: A Randomized Controlled Crossover Trial. Mol Nutr Food Res. 2018 May;62(10):e1701008. doi: 10.1002/mnfr.201701008.
Results Reference
derived

Learn more about this trial

Anti-inflammatory Dietary Intervention in Overweight and Obese Adolescents

We'll reach out to this number within 24 hrs