Anti-inflammatory Dietary Intervention in Overweight and Obese Adolescents

Sponsor

University College Dublin (Other)

Overall Status

Completed

CT.gov ID

NCT01665742

Collaborator

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

Enrollment

Locations

Arms

Duration (Months)

19.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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	Phase
Overweight Obesity	Dietary Supplement: Supplement containing fish oil, vitamin C, alpha-tocopherol, green tea extract and lycopene Dietary Supplement: Placebo supplement	N/A

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

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 :

Jan 1, 2012

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

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 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

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

Outcome Measures

Primary Outcome Measures

Homeostasis model of assessment - insulin resistance [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

Adiponectin [8 weeks]
Adiponectin, a marker of insulin sensitivity, will be determined pre- and post-intervention.
Markers of inflammation [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
Lipid Profile [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
Inflammatory genetic variants [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
Functional molecular analysis (ex-vivo) [8 weeks]
Functional molecular analysis will be conducted to determine which insulin sensitising pathways have been modulated by the intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Trinity Centre for Health Sciences, St, James's Hospital	Dublin 8	Ireland
2	Adelaide and Meath Hospital, Incorporating the National Children's Hospital Dublin,	Dublin	Ireland
3	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

Investigators

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