HIV InfectionsNCT03141918
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
A study testing Curcumin in people with HIV Infections, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Curcumin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Sep 2017to 5 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Antiretroviral therapy has been available for at least 6 months, aged 18 years or over.
Who cannot join
- Individuals with endocrine and pregnant disorders will be excluded.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal Do Rio Grande Do Norte
Natal, Rio Grande do Norte, 59078970
About this study
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Curcumin, Placebo of Curcumin
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
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 of CurcuminOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Curcumin group 1 | Experimental | Intervention will be with intake of curcumin, 1000mg per 30 days Receives: Dietary Supplement: Curcumin |
| Curcumin group 2 | Placebo comparator | Intervention will be with placebo intake of curcumin, 1000mg per 30 days Receives: Other: Placebo of Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 DAYS
Secondary outcomes (9)
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 10 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start8 Sep 2017
- Primary completion24 Oct 2017
- Study completion5 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TATIANE ANDREZA LIMA DA SILVA, Universidade Federal do Rio Grande do Norte
- Investigators
- TATIANE AL SILVA, Ms, Principal investigator, UFRN - Avenida Salgado Filho. S/N. Campus Central. Lagoa Nova. Rio Grande do Norte, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141918
- Sponsor's protocol ID
- COMPOSTOS_BIOATIVOS_VIVER MAIS
- Status last verified
- Jun 2018
- First submitted
- 23 Feb 2017
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 17823426Kosmiski 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.
PubMed 17224345Vassimon 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.
PubMed 22503533
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
- ClinicalTrials.gov ID
- NCT03141918
- Acronym / sponsor ID
- COMPOSTOS_BIOATIVOS_VIVER MAIS
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 24 Oct 2017 (actual)
- Study completion
- 5 Dec 2017 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcumin group 1 | Experimental | Dietary Supplement: CurcuminIntervention will be with intake of curcumin, 1000mg per 30 days |
| Curcumin group 2 | Placebo comparator | Other: Placebo of CurcuminIntervention will be with placebo intake of curcumin, 1000mg per 30 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Antiretroviral therapy has been available for at least 6 months, aged 18 years or over.
Key exclusion criteria (1 listed)
- Individuals with endocrine and pregnant disorders will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminThe 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. | Dietary supplement | Curcumin group 1 |
| Placebo of CurcuminThe intervention will consist of the placebo administration curcumin for 30 days. The Curcumin placebo will be given in 2 doses of 500mg per day. | Other | Curcumin group 2 |
Primary outcome
The oxidation of energetic substrates evaluation at rest
Time frame: 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
9 secondary outcomes
Energy expenditure at rest
Time frame: 10 DAYS
The glycemia evaluation
Time frame: 10 DAYS
The insulin evaluation
Time frame: 10 DAYS
The total cholesterol evalution
Time frame: 10 DAYS
The LDL cholesterol evalution
Time frame: 10 DAYS
The HDL cholesterol evalution
Time frame: 10 DAYS
The triglycerides evalution
Time frame: 10 DAYS
The inflammatory markers evalution
Time frame: 10 DAYS
The oxidative stress markers evalution
Time frame: 10 DAYS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Background: PubMed 17823426Pannacciulli 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.
- Background: PubMed 17224345Kosmiski 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.
- Background: PubMed 22503533Vassimon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TATIANE AL SILVA, Ms principal investigator
UFRN - Avenida Salgado Filho. S/N. Campus Central. Lagoa Nova. Rio Grande do Norte, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin in people with HIV Infections, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The oxidation of energetic substrates evaluation at rest (time frame: 10 DAYS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03141918, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2018.