Anti-inflammatory Dietary Intervention in Overweight and Obese Adolescents

NCT ID: NCT01665742

Last Updated: 2014-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-11-30

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.

Conditions

Overweight; Obesity

Keywords

Obesity; Chronic inflammation; Anti-inflammatory dietary intervention; Genetic susceptibility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DIETARY_SUPPLEMENT

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 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

Group Type: PLACEBO_COMPARATOR

Placebo supplement

Intervention Type: DIETARY_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

Interventions

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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Children's Research Centre, Ireland

NETWORK

Sponsor Role: collaborator

University of Dublin, Trinity College

OTHER

Sponsor Role: collaborator

The Adelaide and Meath Hospital

OTHER

Sponsor Role: collaborator

St. James's Hospital, Ireland

OTHER

Sponsor Role: collaborator

University College Dublin

OTHER

Sponsor Role: lead

Responsible Party

Prof Helen M Roche

Associate Professor of Nutrigenomics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen M Roche, BSc, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

University College Dublin

Fiona Lithander, BSc, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Dublin, Trinity College

Locations

Adelaide and Meath Hospital, Incorporating the National Children's Hospital Dublin,

Dublin, , Ireland

Trinity Centre for Health Sciences, St, James's Hospital

Dublin, , Ireland

University College Dublin

Dublin, , Ireland

Countries

Ireland

References

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.

Reference Type: DERIVED

PMID: 29665620 (View on PubMed)

Other Identifiers

TNS-5

Identifier Type: -

Identifier Source: org_study_id