Clinical trial NCT01665742: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Obesity
Chronic inflammation
Anti-inflammatory dietary intervention
Genetic susceptibility
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: National Children's Research Centre, Ireland
name: University of Dublin, Trinity College
name: The Adelaide and Meath Hospital
name: St. James's Hospital, Ireland
First posted: 2012-08-15
Enrollment: 58
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Homeostasis model of assessment - insulin resistance
timeFrame: 8 weeks
Secondary outcomes:
measure: Adiponectin
timeFrame: 8 weeks
measure: Markers of inflammation
timeFrame: 8 weeks
measure: Lipid Profile
timeFrame: 8 weeks
measure: Inflammatory genetic variants
timeFrame: 8 weeks
measure: Functional molecular analysis (ex-vivo)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Dublin 8
country: Ireland
facility: Trinity Centre for Health Sciences, St, James's Hospital
city: Dublin
country: Ireland
facility: Adelaide and Meath Hospital, Incorporating the National Children's Hospital Dublin,
city: Dublin
country: Ireland
facility: University College Dublin
Study officials:
affiliation: University College Dublin
name: Helen M Roche, BSc, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dublin, Trinity College
name: Fiona Lithander, BSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.