Effects of Omega-3 Long-Chain Polyunsaturated Fatty Acids (N-3 LCPUFA) Supplementation on Body Composition, Biochemical Profile, Diet and Physical Activity of Obese Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 主要终点
- BMI-for-age change
研究概览
简要总结
Omega-3 Long-Chain Polyunsaturated Fatty Acids has potential as a supplement that can accelerate the effects of a weight management program in children. This study assessed the effects of fish oil supplementation on biochemical profile, body composition, diet and physical activity of obese children. A total of 37 obese children (7-11 years) were randomized to intervention (n=19) or control (n=18) group. Data were collected at baseline, at follow-up (every four weeks) and at 24 of the interventions. The intervention group (IG) received stage-based lifestyle modification intervention and fish oil supplement, while the control group (CG) received stage-based lifestyle modification intervention only. Changes in biochemical profile, body composition, diet and physical activity were examined in both intervention and control groups.
详细描述
Main objective To determine the effect of stage-based lifestyle modification and n-3 LCPUFA (DHA and EPA) supplements on body composition, biochemical profile, diet and physical activity of obese children.
Specific objectives
- To compare changes in: i. Primary outcome: BMI-for-age ii. Secondary outcomes: Body composition (waist circumference [WC], mid-upper arm muscle circumference [MUAMC] and body fat percentage)
Biochemical profile:
Lipid profile (total cholesterol [TC], triglyceride [TG], low-density lipoprotein [LDL] and high-density lipoprotein [HDL]), fasting blood glucose (FBG), insulin and Homeostasis model assessment insulin-resistance index (HOMA-IR index), Fatty acid composition (DHA and EPA) Others: Adiponectin, high-sensitivity C-reactive protein (hs-CRP) and serum ferritin iii. Energy and nutrient intakes (Macronutrients, Saturated Fatty Acids [SFA], Polyunsaturated Fatty Acids [PUFA], Monounsaturated Fatty Acids [MUFA], Cholesterol and sugar and dietary fiber) vii. Physical activity between children receiving Stage-based Lifestyle Modification for the Management of Childhood Obesity with or without supplementation of 1320 mg of n-3 LCPUFA (DHA and EPA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
After the parents/caregivers completed the consent form, the participants were age matched and randomized using a permuted block method, with a block size of four, into either IG or CG. To guarantee allocation concealment, we had the recommendation the randomization carried out by an independent third party.
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 7 to 11 years old.
- •Classified as obese (>+2SD) based on BMI-for-age for 5 to 19 years old (WHO, 2007).
排除标准
- •Children diagnosed with asthma, diabetes mellitus (DM), psychiatric disorders (e.g.
- •schizophrenia, severe autism or mental retardation, or psychosis), or other serious medical conditions.
- •Children receiving medications that could potentially promote weight gain or weight loss.was sent to lab for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
- •Children participating in any weight management programmes.
- •Overweight, normal weight and underweight children.
结局指标
主要结局
BMI-for-age change
时间窗: Change from Baseline SBMI-for-age at 24 weeks
Height and weight were measured to calculate BMI-for-age
次要结局
- Mid-Upper Arm Muscle Circumference [cm] Mid-Upper Arm Muscle Circumference(Every four weeks for a duration of 24 weeks)
- Triglyceride mmol/L(week 0, week 16 and week 24)
- waist circumference [cm](Every four weeks for a duration of 24 weeks)
- Total cholesterol [TC] mmol/L(week 0, week 16 and week 24)
- Fasting blood glucose (FBG) mmol/L(week 0, week 16 and week 24)
- Homeostasis model assessment insulin-resistance index (HOMA-IR index)(week 0, week 16 and week 24)
- Adiponectin(week 0, week 16 and week 24)
- High-sensitivity C-reactive protein (hs-CRP)[mg/L](week 0, week 16 and week 24)
- Carbohydrate [g & %](Every four weeks for a duration of 24 weeks)
- Fat [g & %](Every four weeks for a duration of 24 weeks)
- Polyunsaturated fatty acid [g & %](Every four weeks for a duration of 24 weeks)
- Low-density lipoprotein [LDL] mmol/L(week 0, week 16 and week 24)
- High-density lipoprotein [HDL]) mmol/L(week 0, week 16 and week 24)
- Insulin [uU/mL](week 0, week 16 and week 24)
- DHA(week 0, week 16 and week 24)
- EPA(week 0, week 16 and week 24)
- calorie(Every four weeks for a duration of 24 weeks)
- Serum ferritin[ng/mL](week 0, week 16 and week 24)
- Protein [g & %](Every four weeks for a duration of 24 weeks)
- Saturated fatty acid [g & %](Every four weeks for a duration of 24 weeks)
- monounsaturated fatty acid [g & %](Every four weeks for a duration of 24 weeks)
- Fibre [g & %](Every four weeks for a duration of 24 weeks)
- Sugar [g & %](Every four weeks for a duration of 24 weeks)
- Physical activity level(Every four weeks for a duration of 24 weeks)
研究者
Nor Baizura Md. Yusop
Senior Lecturer
Universiti Putra Malaysia