Anti-inflammatory Dietary Intervention in Overweight and Obese Adolescents
الكلمات الدالة
نبذة مختصرة
وصف
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.
تواريخ
| آخر التحقق: | 11/30/2014 |
| تم الإرسال لأول مرة: | 08/11/2012 |
| تم إرسال التسجيل المقدر: | 08/11/2012 |
| أول نشر: | 08/14/2012 |
| تم إرسال آخر تحديث: | 12/04/2014 |
| آخر تحديث تم نشره: | 12/08/2014 |
| تاريخ بدء الدراسة الفعلي: | 12/31/2011 |
| تاريخ الإنجاز الأساسي المقدر: | 10/31/2013 |
| التاريخ المتوقع لانتهاء الدراسة: | 10/31/2013 |
حالة أو مرض
التدخل / العلاج
Dietary Supplement: Anti-inflammatory supplement
Dietary Supplement: Placebo supplement
مرحلة
مجموعات الذراع
| ذراع | التدخل / العلاج |
|---|---|
| Active Comparator: 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 | Dietary Supplement: Anti-inflammatory 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 Comparator: 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 | 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 |
معايير الأهلية
| الأعمار المؤهلة للدراسة | 13 Years إلى 13 Years |
| الأجناس المؤهلة للدراسة | All |
| يقبل المتطوعين الأصحاء | نعم |
| المعايير | 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 |
النتيجة
مقاييس النتائج الأولية
1. Homeostasis model of assessment - insulin resistance [8 weeks]
مقاييس النتائج الثانوية
1. Adiponectin [8 weeks]
2. Markers of inflammation [8 weeks]
3. Lipid Profile [8 weeks]
4. Inflammatory genetic variants [8 weeks]
5. Functional molecular analysis (ex-vivo) [8 weeks]
