Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Children's Research Centre, Ireland | NETWORK |
| University of Dublin, Trinity College | OTHER |
| The Adelaide and Meath Hospital | OTHER |
| St. James's Hospital, Ireland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplement containing fish oil, vitamin C, alpha-tocopherol, green tea extract and lycopene | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adiponectin | Adiponectin, a marker of insulin sensitivity, will be determined pre- and post-intervention. | 8 weeks |
| Markers of inflammation | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Helen M Roche, BSc, MSc, PhD | University College Dublin | Principal Investigator |
| Fiona Lithander, BSc, PhD | University of Dublin, Trinity College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adelaide and Meath Hospital, Incorporating the National Children's Hospital Dublin, | Dublin | Ireland | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29665620 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D020022 | Genetic Predisposition to Disease |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D024502 | alpha-Tocopherol |
| D013662 | Tea |
| D000077276 | Lycopene |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
|
| Placebo supplement | 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 |
|
| 8 weeks |
| Lipid Profile | 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 | 8 weeks |
| Inflammatory genetic variants | 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 | 8 weeks |
| Functional molecular analysis (ex-vivo) | Functional molecular analysis will be conducted to determine which insulin sensitising pathways have been modulated by the intervention | 8 weeks |
| Trinity Centre for Health Sciences, St, James's Hospital |
| Dublin |
| Ireland |
| University College Dublin | Dublin | Ireland |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D024505 | Tocopherols |
| D014810 | Vitamin E |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |