Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Dietary supplement: Curcumin; Other: Placebo of Curcumin

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RN
    • Natal, RN, Brazil, 59078970
      • Universidade Federal do Rio Grande do Norte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Curcumin group 1; Intervention will be with intake of curcumin, 1000mg per 30 days	Dietary supplement: Curcumin; 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.
Placebo Comparator: Curcumin group 2; Intervention will be with placebo intake of curcumin, 1000mg per 30 days	Other: Placebo of Curcumin; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy expenditure at rest	The evaluation of resting energy expenditure 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 energy expenditure of rest. 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 resting energy expenditure, 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
The glycemia evaluation	Individuals will undergo a peripheral vein puncture in the morning after fasting from 12 to 14 h. Blood will be collected in 30 ml of blood in vacuum containment tubes without anticoagulant; Tubes will be identified with a different registration number for each participant.In order to obtain the serum, the blood samples will be centrifuged for 10 min at 2500 rpm at room temperature. Serum levels of glucose will be performed by enzyme-colorimetric assays using Labtest Diagnostic kits suitable for the RA-50 semi-automated biochemical analyzer (Bayer Diagnostics Chemistry System, Dublin).	10 DAYS
The insulin evaluation	Individuals will undergo a peripheral vein puncture in the morning after fasting from 12 to 14 h. Blood will be collected in 30 ml of blood in vacuum containment tubes without anticoagulant; Tubes will be identified with a different registration number for each participant.In order to obtain the serum, the blood samples will be centrifuged for 10 min at 2500 rpm at room temperature.Serum levels of insulin will be performed by enzyme-colorimetric assays using Labtest Diagnostic kits suitable for the RA-50 semi-automated biochemical analyzer (Bayer Diagnostics Chemistry System, Dublin).	10 DAYS
The total cholesterol evalution	Individuals will undergo a peripheral vein puncture in the morning after fasting from 12 to 14 h. Blood will be collected in 30 ml of blood in vacuum containment tubes without anticoagulant; Tubes will be identified with a different registration number for each participant.In order to obtain the serum, the blood samples will be centrifuged for 10 min at 2500 rpm at room temperature.Serum levels of total cholesterol will be performed by enzyme-colorimetric assays using Labtest Diagnostic kits suitable for the RA-50 semi-automated biochemical analyzer (Bayer Diagnostics Chemistry System, Dublin).	10 DAYS
The LDL cholesterol evalution	Individuals will undergo a peripheral vein puncture in the morning after fasting from 12 to 14 h. Blood will be collected in 30 ml of blood in vacuum containment tubes without anticoagulant; Tubes will be identified with a different registration number for each participant.In order to obtain the serum, the blood samples will be centrifuged for 10 min at 2500 rpm at room temperature.Serum levels of LDL cholesterol will be performed by enzyme-colorimetric assays using Labtest Diagnostic kits suitable for the RA-50 semi-automated biochemical analyzer (Bayer Diagnostics Chemistry System, Dublin).	10 DAYS
The HDL cholesterol evalution	Individuals will undergo a peripheral vein puncture in the morning after fasting from 12 to 14 h. Blood will be collected in 30 ml of blood in vacuum containment tubes without anticoagulant; Tubes will be identified with a different registration number for each participant.In order to obtain the serum, the blood samples will be centrifuged for 10 min at 2500 rpm at room temperature.Serum levels of HDL cholesterol will be performed by enzyme-colorimetric assays using Labtest Diagnostic kits suitable for the RA-50 semi-automated biochemical analyzer (Bayer Diagnostics Chemistry System, Dublin).	10 DAYS
The triglycerides evalution	Individuals will undergo a peripheral vein puncture in the morning after fasting from 12 to 14 h. Blood will be collected in 30 ml of blood in vacuum containment tubes without anticoagulant; Tubes will be identified with a different registration number for each participant.In order to obtain the serum, the blood samples will be centrifuged for 10 min at 2500 rpm at room temperature.Serum levels of triglycerides will be performed by enzyme-colorimetric assays using Labtest Diagnostic kits suitable for the RA-50 semi-automated biochemical analyzer (Bayer Diagnostics Chemistry System, Dublin).	10 DAYS
The inflammatory markers evalution	Individuals will undergo a peripheral vein puncture in the morning after fasting from 12 to 14 h. Blood will be collected in 30 ml of blood in vacuum containment tubes without anticoagulant; Tubes will be identified with a different registration number for each participant.In order to obtain the serum, the blood samples will be centrifuged for 10 min at 2500 rpm at room temperature.	10 DAYS
The oxidative stress markers evalution	Individuals will undergo a peripheral vein puncture in the morning after fasting from 12 to 14 h. Blood will be collected in 30 ml of blood in vacuum containment tubes without anticoagulant; Tubes will be identified with a different registration number for each participant.In order to obtain the serum, the blood samples will be centrifuged for 10 min at 2500 rpm at room temperature.	10 DAYS

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	The body composition will be evaluated by the indirect method of Dual Energy Radiological Absortometry (DEXA) through the Prodigy® Lunar Bone Densitometry apparatus.	10 DAYS

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio Grande do Norte
• Investigators: Principal Investigator: TATIANE AL SILVA, Ms, UFRN - Avenida Salgado Filho. S/N. Campus Central. Lagoa Nova. Rio Grande do Norte, Brazil

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2017
• Primary Completion (Actual): October 24, 2017
• Study Completion (Actual): December 5, 2017

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): June 21, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: COMPOSTOS_BIOATIVOS_VIVER MAIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes