Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The oxidation of energetic substrates evaluation at rest
研究概览
简要总结
Among the many changes associated with the impact of HIV and the long-term use of antiretroviral therapy, metabolics are important because they are important risk factors for the development of cardiovascular diseases. The objective of the present study is to evaluate the effect of the supplementation of curcumin, on the oxidation of resting energetic substrates in HIV / AIDS patients. The sample will be composed of adults living with HIV / AIDS on antiretroviral therapy for at least 6 months. Supplements will be made separately for 30 days and will be evaluated before and after the intervention the following parameters: body composition, energy metabolism, biochemical parameters and a structured anamnesis. Food consumption and the level of physical activity of the volunteers will be controlled.
详细描述
The study is characterized as a double-blind randomized clinical trial. Participants in the study will be adults living with HIV / AIDS who undergo regular clinical follow-up at some Specialized HIV / AIDS Care Service.
The sample will consist of 20 volunteers, 10 in the experimental group (GE) and 10 in the control group (CG). Participants will be randomly assigned to one of the groups by lottery by a researcher not participating in the study. The researcher responsible, as well as the volunteers, will not be aware of which participants are in the GE or the GC.
The study will be carried out in the Movement Laboratory of the Physical Education Department of the Federal University of Rio Grande do Norte.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Antiretroviral therapy has been available for at least 6 months, aged 18 years or over.
排除标准
- •Individuals with endocrine and pregnant disorders will be excluded.
研究组 & 干预措施
Curcumin group 2
Intervention will be with placebo intake of curcumin, 1000mg per 30 days
干预措施: Placebo of Curcumin (Other)
Curcumin group 1
Intervention will be with intake of curcumin, 1000mg per 30 days
干预措施: Curcumin (Dietary Supplement)
结局指标
主要结局
The oxidation of energetic substrates evaluation at rest
时间窗: 10 DAYS
The oxidation of energetic substrates evaluation at rest will be performed by indirect calorimetry, a gold standard method for the measurement of energy expenditure, making feasible through the breath by breath technique, weightings to quantify the Caloric expenditure from oxidation fats and carbohydrates. Evaluation will not offer any discomfort since the volunteer will lie flat without moving with a mask fixed on his face, which picks up the breathed and expired gases to be measured by the Respiratory Analyzer - Metalyzer 3B-MICROMED®. To determine oxidation of energetic substrates, subjects will be instructed to sleep approximately for 8 hours the night before, to fast for 12 hours, not to exercise and not to drink caffeinated beverages or alcohol in the 24 hours before the test. Such care should be taken in order to reduce the influence of the thermal effect of food and physical activity on resting metabolism
次要结局
- The HDL cholesterol evalution(10 DAYS)
- The triglycerides evalution(10 DAYS)
- Energy expenditure at rest(10 DAYS)
- The glycemia evaluation(10 DAYS)
- The insulin evaluation(10 DAYS)
- The total cholesterol evalution(10 DAYS)
- The LDL cholesterol evalution(10 DAYS)
- The inflammatory markers evalution(10 DAYS)
- The oxidative stress markers evalution(10 DAYS)
研究者
TATIANE ANDREZA LIMA DA SILVA
Principal Investigator
Universidade Federal do Rio Grande do Norte