Glutathione and Its Precursors in HIV-Infected Patients
Primary Purpose
HIV Infection
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Glutathione precursors
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patient Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Plasma glutathione
Secondary Outcome Measures
Plasma sulfur amino acids
Full Information
NCT ID
NCT00910442
First Posted
May 27, 2009
Last Updated
May 28, 2009
Sponsor
UPECLIN HC FM Botucatu Unesp
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00910442
Brief Title
Glutathione and Its Precursors in HIV-Infected Patients
Official Title
The Effect of Substrate Supply on Modulating Plasma GSH Levels in Treated HIV+ Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UPECLIN HC FM Botucatu Unesp
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Glutathione precursors
Other Intervention Name(s)
Glutamine (L-glutamine), NAC (N-acetyl-L-cysteine)
Intervention Description
HIV+ patients were assigned to 7 day diets containing either NAC or Gln
Primary Outcome Measure Information:
Title
Plasma glutathione
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Plasma sulfur amino acids
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto C Burini, PhD
Organizational Affiliation
UNESP Medical School
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
29392418
Citation
Burini RC, Borges-Santos MD, Moreto F, Yu YM. Comparative effects of acute-methionine loading on the plasma sulfur-amino acids in NAC-supplemented HIV+ patients and healthy controls. Amino Acids. 2018 May;50(5):569-576. doi: 10.1007/s00726-018-2538-2. Epub 2018 Feb 1.
Results Reference
derived
PubMed Identifier
22261571
Citation
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.
Results Reference
derived
Learn more about this trial
Glutathione and Its Precursors in HIV-Infected Patients
We'll reach out to this number within 24 hrs