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Glutathione and Its Precursors in HIV-Infected Patients

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT00910442
First received: May 27, 2009
Last updated: May 28, 2009
Last verified: May 2009

May 27, 2009
May 28, 2009
February 2002
February 2007   (final data collection date for primary outcome measure)
Plasma glutathione [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00910442 on ClinicalTrials.gov Archive Site
Plasma sulfur amino acids [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Glutathione and Its Precursors in HIV-Infected Patients
The Effect of Substrate Supply on Modulating Plasma GSH Levels in Treated HIV+ Patients

The aim of this study is to investigate the responses of the serum amyloid A (SAA) pathway to dietary supplements of glutamine (Gln) and cysteine (Cys) together with methionine (Met)-overloading in HIV+ patients comparatively to healthy controls.

Introduction: Among the 4 sulphur-containing amino acids (SAA), only Met and Cys are incorporated into proteins, but Hcy and Tau are related to oxidative stress and glutathione (GSH), the major intracellular hydro-soluble anti-oxidant agent. HIV+ patients present low levels of antioxidant nutrients, including GSH and its precursors.

Objective: To investigate the responses of the SAA pathway to dietary supplements of Gln and Cys together with Met-overloading in HIV+ patients comparatively to healthy controls.

Methods: Twelve HIV+ (6 males and 6 females, 25-36 yrs old) patients under HAART (one HIV protease inhibitor in combination with two nucleoside analogs) for at least one year and 20 (10M and 10F, 23-28 yrs old) healthy controls were randomly assigned to 7-day diets containing either NAC (N-acetylcysteine, 1g/d) or Gln (20g/d), with a 7-day washout period with their usual diet (UD). Blood samples were drawn after overnight fast before and after (2h and 4h) ingesting the Met (100 mg/kg) overload (Met-OL) with determination of the area under the curve (AUC). HPLC plasma analysis of SAA (Met, Hcy, Cys and Tau), GSH and GSSG and Ser, Gly, Glu and Gln was carried out at moments before (MO) and after 7-day diets (M1). Additionally, at baseline, both groups were assessed for anthropometry (BMI, kg/m2; body fat %) and plasma biochemistry (creatinine, urea, γ-glutamyl transpeptidase, glucose, triglycerides, cholesterol, uric acid, albumin, folic acid and vitamin B12).The HIV+ group (G2) was also characterized by the viral load, CD4+ and CD8+ lymphocytes counts. Statistical comparisons were undertaken among diets between groups with p = 0.05.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infection
Dietary Supplement: Glutathione precursors
HIV+ patients were assigned to 7 day diets containing either NAC or Gln
Other Names:
  • Glutamine (L-glutamine)
  • NAC (N-acetyl-L-cysteine)
  • Experimental: Patient Group
    Dietary supplement:N-acetylcysteine 1g/day and Glutamine 20g/day for 7 consecutive days. The dietary supplements were intermediated by 7 days of washout with usual diet.
    Intervention: Dietary Supplement: Glutathione precursors
  • Active Comparator: Control Group
    Healthy HIV negative subjects submitted to the same dietary supplement than experimental group: N-acetylcysteine 1g/day and Glutamine 20g/day for 7 consecutive days. The dietary supplements were intermediated by 7 days of washout with usual diet.
    Intervention: Dietary Supplement: Glutathione precursors
Borges-Santos MD, Moreto F, Pereira PC, Ming-Yu Y, Burini RC. Plasma glutathione of HIV⁺ patients responded positively and differently to dietary supplementation with cysteine or glutamine. Nutrition. 2012 Jul;28(7-8):753-6. doi: 10.1016/j.nut.2011.10.014. Epub 2012 Jan 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
February 2009
February 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV infection
  • antiretroviral therapy for at least one year

Exclusion Criteria:

  • presence of any renal or liver failure
  • ingestion of either vitamins B or GSH precursors
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00910442
upeclin/HC/FMB-Unesp-24
Yes
Roberto Carlos Burini, UNESP Faculdade de Medicina de Botucatu
UPECLIN HC FM Botucatu Unesp
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Roberto C Burini, PhD UNESP Medical School
UPECLIN HC FM Botucatu Unesp
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP