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

NCT ID: NCT03141918

Last Updated: 2018-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-08

Study Completion Date

2017-12-05

Brief Summary

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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

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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

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Curcumin group 1

Intervention will be with intake of curcumin, 1000mg per 30 days

Group Type EXPERIMENTAL

Curcumin

Intervention Type DIETARY_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.

Curcumin group 2

Intervention will be with placebo intake of curcumin, 1000mg per 30 days

Group Type PLACEBO_COMPARATOR

Placebo of Curcumin

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role lead

Responsible Party

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TATIANE ANDREZA LIMA DA SILVA

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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TATIANE AL SILVA, Ms

Role: PRINCIPAL_INVESTIGATOR

UFRN - Avenida Salgado Filho. S/N. Campus Central. Lagoa Nova. Rio Grande do Norte, Brazil

Locations

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Universidade Federal Do Rio Grande Do Norte

Natal, Rio Grande do Norte, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 17823426 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17224345 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22503533 (View on PubMed)

Other Identifiers

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COMPOSTOS_BIOATIVOS_VIVER MAIS

Identifier Type: -

Identifier Source: org_study_id

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