Clinical trial NCT03141918: Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
Official title: Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Antiretroviral therapy has been available for at least 6 months, aged 18 years or over.

Exclusion Criteria:

* Individuals with endocrine and pregnant disorders will be excluded.

Primary outcomes:
measure: The oxidation of energetic substrates evaluation at rest
timeFrame: 10 DAYS
Secondary outcomes:
measure: Energy expenditure at rest
timeFrame: 10 DAYS
measure: The glycemia evaluation
timeFrame: 10 DAYS
measure: The insulin evaluation
timeFrame: 10 DAYS
measure: The total cholesterol evalution
timeFrame: 10 DAYS
measure: The LDL cholesterol evalution
timeFrame: 10 DAYS
measure: The HDL cholesterol evalution
timeFrame: 10 DAYS
measure: The triglycerides evalution
timeFrame: 10 DAYS
measure: The inflammatory markers evalution
timeFrame: 10 DAYS
measure: The oxidative stress markers evalution
timeFrame: 10 DAYS
Other outcomes:
measure: Body composition
timeFrame: 10 DAYS
Locations:
city: Natal
country: Brazil
facility: Universidade Federal Do Rio Grande Do Norte
state: RN
Study officials:
affiliation: UFRN - Avenida Salgado Filho. S/N. Campus Central. Lagoa Nova. Rio Grande do Norte, Brazil
name: TATIANE AL SILVA, Ms
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pannacciulli N, Salbe AD, Ortega E, Venti CA, Bogardus C, Krakoff J. The 24-h carbohydrate oxidation rate in a human respiratory chamber predicts ad libitum food intake. Am J Clin Nutr. 2007 Sep;86(3):625-32. doi: 10.1093/ajcn/86.3.625.
citation: Kosmiski LA, Bessesen DH, Stotz SA, Koeppe JR, Horton TJ. Short-term energy restriction reduces resting energy expenditure in patients with HIV lipodystrophy and hypermetabolism. Metabolism. 2007 Feb;56(2):289-95. doi: 10.1016/j.metabol.2006.10.012.
citation: Vassimon HS, de Paula FJ, Machado AA, Monteiro JP, Jordao AA Jr. Hypermetabolism and altered substrate oxidation in HIV-infected patients with lipodystrophy. Nutrition. 2012 Sep;28(9):912-6. doi: 10.1016/j.nut.2011.12.010. Epub 2012 Apr 13.