NCT01665742

Anti-inflammatory Dietary Intervention in Overweight and Obese Adolescents

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: University College Dublin · Academic / Other
• Sex: All
• Age: 13 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-08-15
• Last updated: 2014-12-09

Locations

3 sites across 1 country: Ireland