Effect of Supplementation With Glutamine and Exercise in Women With HIV/AIDS
Impact of Physical Exercise Associated With Glutamine Supplementation in Health Indicators of People Living With HIV/AIDS
1 other identifier
interventional
14
0 countries
N/A
Brief Summary
This study aimed to investigate the effect of an exercise session with weights associated with glutamine dipeptide (GLD) supplementation on cognitive function of people living with HIV/ AIDS. The sample consisted of 10 HIV+ women, who used the Antiretroviral Therapy Highly Active. The participants were randomized in a double-blind procedure to receive seven days of supplementation GLD or placebo (PLA). At the end of this first period, the participants held a workout with weights with cognitive assessments before and immediately after the session. To evaluate oxidative stress markers blood samples were collected before and 1 hour and 2 hours after the session.Then the participants rested for 7 days for the initial stocks of glutamine return to baseline levels (washout). Following was realized the crossing of the groups, so those who had received the GLD in the first week spent extra for 7 days with PLA and vice versa, and then they repeated evaluations and exercise session. The exercise session consisted of seven resistance exercises involving different muscle groups, with three sets of 8-12 repetitions with an interval of 90 seconds between sets and 120 seconds between the exercises. Stroop test was used to cognitive assessments, which aims to assess selective attention and inhibitory control over the color of conflict and word, and the N-back test, responsible for evaluating the central executive component of working memory by stimuli visual. Oxidative stress markers (TBARS, FOX, GSH, GSSG, AOPP) were analyzed in plasma samples.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 28, 2017
CompletedFirst Posted
Study publicly available on registry
August 2, 2017
CompletedAugust 22, 2017
August 1, 2017
2 months
July 28, 2017
August 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The effect of a short period of supplementation with glutamine dipeptide in the cognitive responses after a resistance training session of women with HIV/AIDS
On the seventh day of supplementation all participants did cognitive function tests before and immediately after a resistance training session.
Before and immediately after a resistance training session
Secondary Outcomes (1)
The effect of a short period of supplementation with glutamine dipeptide in the oxidative stress markers after a resistance training session of women with HIV/AIDS
Before, 1 hour and 2 hours after a resistance training session
Study Arms (2)
Glutamine and exercise
EXPERIMENTALGlutamine dipeptide (20g/day) in 300 ml of water and ingest it after lunch during 7 days. In case of forgetfulness, they were suggested to ingest it soon after dinner. All participants were instructed to maintain their routine eating habits throughout the duration of the study. On the seventh and last day of supplementation, they were submitted to the resistance training session.
Maltodextrin and exercise
PLACEBO COMPARATORMaltodextrin (20g/day) in 300 ml of water and ingest it after lunch during 7 days. In case of forgetfulness, they were suggested to ingest it soon after dinner. All participants were instructed to maintain their routine eating habits throughout the duration of the study. On the seventh and last day of supplementation, they were submitted to the resistance training session.
Interventions
Eligibility Criteria
You may qualify if:
- Using the Antiretroviral Therapy (ART) for more than six months;
- Have a stabilized clinical picture and viral load.
You may not qualify if:
- Physical training programs during the preceding six months;
- Acute or chronic inflammations that could affect the practice of physical exercise;
- Psychiatric disorders;
- Pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
Somani BL, Ambade V, Bulakh PM, Sharma YV. Elimination of superoxide dismutase interference in fructosamine assay. Clin Biochem. 1999 Apr;32(3):185-8. doi: 10.1016/s0009-9120(99)00016-8.
PMID: 10383078BACKGROUNDAebi H. Catalase in vitro. Methods Enzymol. 1984;105:121-6. doi: 10.1016/s0076-6879(84)05016-3. No abstract available.
PMID: 6727660BACKGROUNDWitko-Sarsat V, Friedlander M, Capeillere-Blandin C, Nguyen-Khoa T, Nguyen AT, Zingraff J, Jungers P, Descamps-Latscha B. Advanced oxidation protein products as a novel marker of oxidative stress in uremia. Kidney Int. 1996 May;49(5):1304-13. doi: 10.1038/ki.1996.186.
PMID: 8731095BACKGROUNDNielsen F, Mikkelsen BB, Nielsen JB, Andersen HR, Grandjean P. Plasma malondialdehyde as biomarker for oxidative stress: reference interval and effects of life-style factors. Clin Chem. 1997 Jul;43(7):1209-14.
PMID: 9216458BACKGROUNDde Souza DC, da Silva JC, Matos FO, Okano AH, Bazotte RB, Avelar A. The Effect of a Short Period of Supplementation with Glutamine Dipeptide on the Cognitive Responses after a Resistance Training Session of Women with HIV/AIDS: A Randomized Double-Blind Placebo-Controlled Crossover Study. Biomed Res Int. 2018 Apr 3;2018:2525670. doi: 10.1155/2018/2525670. eCollection 2018.
PMID: 29850491DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ademar Avelar, PhD
University of Maringá
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- The substances were packed in sachets containing GDP (glutamine) or maltodextrin (placebo). The packages were identical and the substances used had a similar color and texture. An external subject organized group division and substances delivery.
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 28, 2017
First Posted
August 2, 2017
Study Start
October 1, 2015
Primary Completion
December 1, 2015
Study Completion
February 1, 2016
Last Updated
August 22, 2017
Record last verified: 2017-08