NCT01665742

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

1.8 years

First QC Date

August 12, 2012

Last Update Submit

December 5, 2014

Conditions

OverweightObesity

Keywords

ObesityChronic inflammationAnti-inflammatory dietary interventionGenetic susceptibility

Outcome Measures

Primary Outcomes (1)

  • 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

    8 weeks

Secondary Outcomes (5)

  • Adiponectin

    8 weeks

  • Markers of inflammation

    8 weeks

  • Lipid Profile

    8 weeks

  • Inflammatory genetic variants

    8 weeks

  • Functional molecular analysis (ex-vivo)

    8 weeks

Study Arms (2)

Anti-inflammatory supplement

ACTIVE COMPARATOR

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

Placebo supplement

PLACEBO COMPARATOR

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

Interventions

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

Anti-inflammatory supplement
Placebo supplementDIETARY_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

Placebo supplement

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male or female
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Dublin, Ireland

Location

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

Dublin, Ireland

Location

University College Dublin

Dublin, Ireland

Location

Related Publications (1)

  • 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.

    PMID: 29665620DERIVED

MeSH Terms

Conditions

OverweightObesityGenetic Predisposition to Disease

Interventions

Ascorbic Acidalpha-TocopherolTeaLycopene

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDisease SusceptibilityDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesTocopherolsVitamin EBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPlant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Helen M Roche, BSc, MSc, PhD

    University College Dublin

    PRINCIPAL INVESTIGATOR

  • Fiona Lithander, BSc, PhD

    University of Dublin, Trinity College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Nutrigenomics

Study Record Dates

First Submitted

August 12, 2012

First Posted

August 15, 2012

Study Start

January 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

December 9, 2014

Record last verified: 2014-12

Locations

IE(3)