Novel Anti-inflammatory Dietary Intervention to Improve the Metabolic Phenotype of Overweight and Obese 13-18 Year Old Adolescents - Insights Into Potential Genetic Susceptibility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 3
- 主要终点
- Homeostasis model of assessment - insulin resistance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •13-18 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
排除标准
- •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
结局指标
主要结局
Homeostasis model of assessment - insulin resistance
时间窗: 8 weeks
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
次要结局
- Lipid Profile(8 weeks)
- Inflammatory genetic variants(8 weeks)
- Functional molecular analysis (ex-vivo)(8 weeks)
- Adiponectin(8 weeks)
- Markers of inflammation(8 weeks)
研究者
Prof Helen M Roche
Associate Professor of Nutrigenomics
University College Dublin