Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
Started Sep 2017
Shorter than P25 for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2017
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedStudy Start
First participant enrolled
September 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2017
CompletedJune 21, 2018
June 1, 2018
2 months
February 23, 2017
June 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The oxidation of energetic substrates evaluation at rest
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
10 DAYS
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Other Outcomes (1)
Body composition
10 DAYS
Study Arms (2)
Curcumin group 1
EXPERIMENTALIntervention will be with intake of curcumin, 1000mg per 30 days
Curcumin group 2
PLACEBO COMPARATORIntervention will be with placebo intake of curcumin, 1000mg per 30 days
Interventions
The intervention will consist of the supplementation of curcumin for 30 days. Curcumin supplementation will be done by administration of 2 doses of 500mg of the product BioMor Curcumin® which is composed of 95% standardized extract of the root extract of Curcuma longa.
The intervention will consist of the placebo administration curcumin for 30 days. The Curcumin placebo will be given in 2 doses of 500mg per day.
Eligibility Criteria
You may qualify if:
- Antiretroviral therapy has been available for at least 6 months, aged 18 years or over.
You may not qualify if:
- Individuals with endocrine and pregnant disorders will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal Do Rio Grande Do Norte
Natal, Rio Grande do Norte, 59078970, Brazil
Related Publications (3)
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.
PMID: 17823426BACKGROUNDKosmiski 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.
PMID: 17224345BACKGROUNDVassimon 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.
PMID: 22503533BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
TATIANE AL SILVA, Ms
UFRN - Avenida Salgado Filho. S/N. Campus Central. Lagoa Nova. Rio Grande do Norte, Brazil
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 23, 2017
First Posted
May 5, 2017
Study Start
September 8, 2017
Primary Completion
October 24, 2017
Study Completion
December 5, 2017
Last Updated
June 21, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share