<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03236532</url>
  </required_header>
  <id_info>
    <org_study_id>State University of Maringá</org_study_id>
    <nct_id>NCT03236532</nct_id>
  </id_info>
  <brief_title>Effect of Supplementation With Glutamine and Exercise in Women With HIV/AIDS</brief_title>
  <official_title>Impact of Physical Exercise Associated With Glutamine Supplementation in Health Indicators of People Living With HIV/AIDS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of Maringá</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Conselho Nacional de Desenvolvimento Científico e Tecnológico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>State University of Maringá</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to investigate the effect of an exercise session with weights associated&#xD;
      with glutamine dipeptide (GLD) supplementation on cognitive function of people living with&#xD;
      HIV/ AIDS. The sample consisted of 10 HIV+ women, who used the Antiretroviral Therapy Highly&#xD;
      Active. The participants were randomized in a double-blind procedure to receive seven days of&#xD;
      supplementation GLD or placebo (PLA). At the end of this first period, the participants held&#xD;
      a workout with weights with cognitive assessments before and immediately after the session.&#xD;
      To evaluate oxidative stress markers blood samples were collected before and 1 hour and 2&#xD;
      hours after the session.Then the participants rested for 7 days for the initial stocks of&#xD;
      glutamine return to baseline levels (washout). Following was realized the crossing of the&#xD;
      groups, so those who had received the GLD in the first week spent extra for 7 days with PLA&#xD;
      and vice versa, and then they repeated evaluations and exercise session. The exercise session&#xD;
      consisted of seven resistance exercises involving different muscle groups, with three sets of&#xD;
      8-12 repetitions with an interval of 90 seconds between sets and 120 seconds between the&#xD;
      exercises. Stroop test was used to cognitive assessments, which aims to assess selective&#xD;
      attention and inhibitory control over the color of conflict and word, and the N-back test,&#xD;
      responsible for evaluating the central executive component of working memory by stimuli&#xD;
      visual. Oxidative stress markers (TBARS, FOX, GSH, GSSG, AOPP) were analyzed in plasma&#xD;
      samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the present study was to investigate the effect of a short period of&#xD;
      supplementation with glutamine dipeptide (GDP) in the acute responses to resistance training&#xD;
      on people living with HIV/AIDS i the following healthy indicators: executive functions,&#xD;
      stress oxidative markers, cardiovascular functions, inflammatory markers and biochemical&#xD;
      markers.&#xD;
&#xD;
      Participants 14 women diagnosed with HIV+ participated in this study. As inclusion criteria,&#xD;
      they should be over 18 years old; they should have regularly been using the Antiretroviral&#xD;
      Therapy (ART) for more than six months; they should have a stabilized clinical picture and&#xD;
      viral load; they should not have participated in physical training programs during the&#xD;
      preceding six months; they should not show acute or chronic inflammations that could affect&#xD;
      the practice of physical exercise; they should not have psychiatric disorders; and they&#xD;
      should not be pregnant.&#xD;
&#xD;
      The individuals who met the inclusion criteria received clinical evaluation by the infectious&#xD;
      physician responsible for the treatment based on the history of each patient, the laboratory&#xD;
      tests and the clinical picture.&#xD;
&#xD;
      The study was approved by the Standing Committee on Ethical Research with Humans of the State&#xD;
      University of Maringá - PR - Brazil. The volunteers signed the Free Informed Consent Form,&#xD;
      after being informed about the study proposal and the procedures they would be submitted to.&#xD;
&#xD;
      During the study period, four participants were not able to attend all the evaluations and&#xD;
      were excluded from the final analysis. Therefore, 10 women participated in all the procedures&#xD;
      and were part of the final sample of the study.&#xD;
&#xD;
      Experimental design The study had a total duration of five weeks divided into two phases. The&#xD;
      first phase lasted two weeks and was characterized by the familiarization with the exercises&#xD;
      that would be done in the second phase. This protocol consisted of four sessions of&#xD;
      exercises, every 48 hours, which submitted the individuals to the same procedures that would&#xD;
      be done in the second phase. Four familiarization sessions were chosen, one of which was&#xD;
      aimed at learning the exercises without the insertion of loads. Then, the participants could&#xD;
      rest for a week before starting the second phase.&#xD;
&#xD;
      The second phase consisted of three stages; each of them lasted one week. In the first stage,&#xD;
      the participants were initially randomly separated in a double-blind way in order to ingest&#xD;
      either the GDP (Condition 1) or maltodextrin as a placebo (Condition 2) for seven days. On&#xD;
      the seventh and last day of supplementation, they were submitted to the resistance training&#xD;
      session. Before the exercise session the cognitive tests were applied, blood samples were&#xD;
      collected for analysis of biochemical, inflammatory and oxidative stress markers. Immediately&#xD;
      after the exercise session the cognitive tests were repeated. Blood samples were also&#xD;
      collected 1 and 2 hours after the exercise training. Cardiovascular functions were&#xD;
      monitorated during 1 hour after the exercise session, every 10 minutes. After these&#xD;
      procedures there was one-week rest period (step 2). Then, the procedures performed in the&#xD;
      first step were repeated (step 3). However, the group that had received GDP started to&#xD;
      receive maltodextrin, and the group who had received maltodextrin started to receive GDP,&#xD;
      adopting, thus, a randomized double-blind crossover design.&#xD;
&#xD;
      The resistance training protocol The exercises were based on the Guideline for the&#xD;
      prescription of exercise to be given to people with HIV/AIDS. The training session consisted&#xD;
      of seven exercises with weights (chest press, leg press 45º, lat pulldown machine, knee&#xD;
      extension, triceps pulley, knee curl, Scott biceps curl machine) involving different muscle&#xD;
      groups with three series per exercise.&#xD;
&#xD;
      The recovery interval adopted was of 90 seconds between the series and 120 seconds between&#xD;
      exercises. The number of repetitions used in each one of these series was of 8-12 repetitions&#xD;
      by applying the method of fixed loads. The loads were compatible with the number of&#xD;
      repetitions stipulated for each exercise. The load determination occurred during&#xD;
      familiarization sessions.&#xD;
&#xD;
      The OMNI Resistance Exercise Scale (OMNI-RES) of effort subjective perception was used to&#xD;
      determine and control the loads of each exercise. The loads used during the experimental&#xD;
      sessions corresponded to the intensity equivalent to the interval from five to seven (5-7) of&#xD;
      the OMNI-RES scale.&#xD;
&#xD;
      In order to achieve such a purpose, prior to the beginning of familiarization with the&#xD;
      exercises, the OMNI-RES scale anchoring was performed. This procedure consists of placing the&#xD;
      patient in the smallest and highest possible load in each exercise so that he/she can&#xD;
      differentiate a smaller and a greater subjective perception of effort.&#xD;
&#xD;
      Supplementation Protocol The participants were randomly double-blinded indicated to receive&#xD;
      either GDP (20g/day) or maltodextrin (20g/day) according to the literature. The substances&#xD;
      were packed in sachets containing GDP or maltodextrin (placebo). The packages were identical&#xD;
      and the substances used had a similar color and texture. Participants were instructed to&#xD;
      dilute GDP or maltodextrin in 300 ml of water and ingest it after lunch. In case of&#xD;
      forgetfulness, they were suggested to ingest it soon after dinner. All participants were&#xD;
      instructed to maintain their routine eating habits throughout the duration of the study.&#xD;
&#xD;
      Evaluation of the cognitive status Considering the general evaluation of possible cognitive&#xD;
      impairments, the Mini Mental State Examination (MMSE) was used, which provides information on&#xD;
      different cognitive parameters, considering the level of education of the individual&#xD;
      evaluated.&#xD;
&#xD;
      In order to assess the indicatives of HIV-associated dementia the International HIV Dementia&#xD;
      Scale was applied.&#xD;
&#xD;
      Executive Functions The Victoria Stroop color-word test was used to evaluate the executive&#xD;
      functions, which consists of 72 stimuli, distributed in three cards with 24 items each (A, B,&#xD;
      C). The subject must verbalize the name of the colors with which the stimuli of each card&#xD;
      were printed as quickly as possible; the time spent to read each of the cards separately was&#xD;
      registered. The latency time, which is determined by the difference between the time spent&#xD;
      with the responses to the three cards, was used to evaluate selective attention and&#xD;
      inhibitory control.&#xD;
&#xD;
      The n-back test was used to evaluate the operational memory. Visual stimuli were used in this&#xD;
      study, which were represented by colors, divided into three levels (N1, N2, and N3) with 150&#xD;
      stimuli each. The score of each participant was obtained from the percentage values of the&#xD;
      hits recorded in the three levels in a computerized version of the test.&#xD;
&#xD;
      Biochemical analysis Blood samples (10ml) were collected by venose puncture in heparinized&#xD;
      vacutainer® tubes. Plasma glucose concentration were determined both using a glucose analyzer&#xD;
      and using standard kit. Total cholesterol, HDL cholesterol and triglycerides were analysed by&#xD;
      standard methods.&#xD;
&#xD;
      Inflammatory markers Plasma samples were also used to analyse interleukins 2, 6, 8 and 10 and&#xD;
      TNFα using standard kits.&#xD;
&#xD;
      Oxidative stress markers Plasma malondialdehyde (MDA) was determined by high-performance&#xD;
      liquid chromatography (UV/VIS SPD-20A SHIMADZU, Kioto, Japan) as described by Nielsen et al.&#xD;
      Thiobarbituric acid reactive substances (TBARS) and Total hydroperoxide (FOX) were assessed&#xD;
      as plasma lipid peroxidation biomarkers according to method described by Costa et al, and the&#xD;
      advanced oxidation protein products (AOPP) were based on the method described by Witko-Sarsat&#xD;
      et al. GSH and GSSG contents were measured using standart kits. Antioxidant enzyme&#xD;
      activities, superoxide dismutase (SOD) and catalase (CAT) were determined according to Somani&#xD;
      et al and Aebi, respectively.&#xD;
&#xD;
      Cardiovascular functions The evaluation of the participants' cardiovascular responses were&#xD;
      made through the Checking of Resting Blood Pressure with the use of a Sphygmomanometer. All&#xD;
      measurements were performed with main arm, in triplicate, with patients lying at rest for at&#xD;
      least 10 minutes. The heart rate were continuously monitored, after the exercise session,&#xD;
      through a cardiac frequency monitor over an hour, every 10 minutes.&#xD;
&#xD;
      Autonomic modulation of the cardiovascular system were analyzed by means of the spectral&#xD;
      analysis of heart rate variability. For this, the individuals were in rest, in the pre- and&#xD;
      post-exercise moments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2015</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>In the first stage, the participants were initially randomly separated in a double-blind way in order to ingest either the GDP (Condition 1) or maltodextrin as a placebo (Condition 2) for seven days. On the seventh and last day of supplementation, they were submitted to the resistance training session. Before and immediately after the exercise session, the cognitive tests were applied. After these procedures there was a one-week rest period (step 2). Then the procedures performed in the first step were repeated (step 3). However, the group that had received GDP started to receive maltodextrin, and the group who had received maltodextrin started to receive GDP, adopting, thus, a randomized double-blind crossover design.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>Before and immediately after a resistance training session</time_frame>
    <description>On the seventh day of supplementation all participants did cognitive function tests before and immediately after a resistance training session.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>Before, 1 hour and 2 hours after a resistance training session</time_frame>
    <description>On the seventh day of supplementation all participants had blood collected before, 1 hour and 2 hours after a resistance training session.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Glutamine; Metabolic Disorder</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Glutamine and exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Glutamine 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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maltodextrin and exercise</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Maltodextrin (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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Glutamine and exercise</intervention_name>
    <arm_group_label>Glutamine and exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Maltodextrin and exercise</intervention_name>
    <arm_group_label>Maltodextrin and exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Using the Antiretroviral Therapy (ART) for more than six months;&#xD;
&#xD;
          -  Have a stabilized clinical picture and viral load.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physical training programs during the preceding six months;&#xD;
&#xD;
          -  Acute or chronic inflammations that could affect the practice of physical exercise;&#xD;
&#xD;
          -  Psychiatric disorders;&#xD;
&#xD;
          -  Pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ademar Avelar, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maringá</affiliation>
  </overall_official>
  <reference>
    <citation>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.</citation>
    <PMID>10383078</PMID>
  </reference>
  <reference>
    <citation>Aebi H. Catalase in vitro. Methods Enzymol. 1984;105:121-6. doi: 10.1016/s0076-6879(84)05016-3. No abstract available.</citation>
    <PMID>6727660</PMID>
  </reference>
  <reference>
    <citation>Witko-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.</citation>
    <PMID>8731095</PMID>
  </reference>
  <reference>
    <citation>Nielsen 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.</citation>
    <PMID>9216458</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of Maringá</investigator_affiliation>
    <investigator_full_name>Ademar Avelar de Almeida Junior</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>HIV/AIDS; Resistance training, supplementation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03236532
org study id: State University of Maringá
nct id: NCT03236532
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
The aim of the present study was to investigate the effect of a short period of
      supplementation with glutamine dipeptide (GDP) in the acute responses to resistance training
      on people living with HIV/AIDS i the following healthy indicators: executive functions,
      stress oxidative markers, cardiovascular functions, inflammatory markers and biochemical
      markers.

      Participants 14 women diagnosed with HIV+ participated in this study. As inclusion criteria,
      they should be over 18 years old; they should have regularly been using the Antiretroviral
      Therapy (ART) for more than six months; they should have a stabilized clinical picture and
      viral load; they should not have participated in physical training programs during the
      preceding six months; they should not show acute or chronic inflammations that could affect
      the practice of physical exercise; they should not have psychiatric disorders; and they
      should not be pregnant.

      The individuals who met the inclusion criteria received clinical evaluation by the infectious
      physician responsible for the treatment based on the history of each patient, the laboratory
      tests and the clinical picture.

      The study was approved by the Standing Committee on Ethical Research with Humans of the State
      University of Maringá - PR - Brazil. The volunteers signed the Free Informed Consent Form,
      after being informed about the study proposal and the procedures they would be submitted to.

      During the study period, four participants were not able to attend all the evaluations and
      were excluded from the final analysis. Therefore, 10 women participated in all the procedures
      and were part of the final sample of the study.

      Experimental design The study had a total duration of five weeks divided into two phases. The
      first phase lasted two weeks and was characterized by the familiarization with the exercises
      that would be done in the second phase. This protocol consisted of four sessions of
      exercises, every 48 hours, which submitted the individuals to the same procedures that would
      be done in the second phase. Four familiarization sessions were chosen, one of which was
      aimed at learning the exercises without the insertion of loads. Then, the participants could
      rest for a week before starting the second phase.

      The second phase consisted of three stages; each of them lasted one week. In the first stage,
      the participants were initially randomly separated in a double-blind way in order to ingest
      either the GDP (Condition 1) or maltodextrin as a placebo (Condition 2) for seven days. On
      the seventh and last day of supplementation, they were submitted to the resistance training
      session. Before the exercise session the cognitive tests were applied, blood samples were
      collected for analysis of biochemical, inflammatory and oxidative stress markers. Immediately
      after the exercise session the cognitive tests were repeated. Blood samples were also
      collected 1 and 2 hours after the exercise training. Cardiovascular functions were
      monitorated during 1 hour after the exercise session, every 10 minutes. After these
      procedures there was one-week rest period (step 2). Then, the procedures performed in the
      first step were repeated (step 3). However, the group that had received GDP started to
      receive maltodextrin, and the group who had received maltodextrin started to receive GDP,
      adopting, thus, a randomized double-blind crossover design.

      The resistance training protocol The exercises were based on the Guideline for the
      prescription of exercise to be given to people with HIV/AIDS. The training session consisted
      of seven exercises with weights (chest press, leg press 45º, lat pulldown machine, knee
      extension, triceps pulley, knee curl, Scott biceps curl machine) involving different muscle
      groups with three series per exercise.

      The recovery interval adopted was of 90 seconds between the series and 120 seconds between
      exercises. The number of repetitions used in each one of these series was of 8-12 repetitions
      by applying the method of fixed loads. The loads were compatible with the number of
      repetitions stipulated for each exercise. The load determination occurred during
      familiarization sessions.

      The OMNI Resistance Exercise Scale (OMNI-RES) of effort subjective perception was used to
      determine and control the loads of each exercise. The loads used during the experimental
      sessions corresponded to the intensity equivalent to the interval from five to seven (5-7) of
      the OMNI-RES scale.

      In order to achieve such a purpose, prior to the beginning of familiarization with the
      exercises, the OMNI-RES scale anchoring was performed. This procedure consists of placing the
      patient in the smallest and highest possible load in each exercise so that he/she can
      differentiate a smaller and a greater subjective perception of effort.

      Supplementation Protocol The participants were randomly double-blinded indicated to receive
      either GDP (20g/day) or maltodextrin (20g/day) according to the literature. The substances
      were packed in sachets containing GDP or maltodextrin (placebo). The packages were identical
      and the substances used had a similar color and texture. Participants were instructed to
      dilute GDP or maltodextrin in 300 ml of water and ingest it after lunch. 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.

      Evaluation of the cognitive status Considering the general evaluation of possible cognitive
      impairments, the Mini Mental State Examination (MMSE) was used, which provides information on
      different cognitive parameters, considering the level of education of the individual
      evaluated.

      In order to assess the indicatives of HIV-associated dementia the International HIV Dementia
      Scale was applied.

      Executive Functions The Victoria Stroop color-word test was used to evaluate the executive
      functions, which consists of 72 stimuli, distributed in three cards with 24 items each (A, B,
      C). The subject must verbalize the name of the colors with which the stimuli of each card
      were printed as quickly as possible; the time spent to read each of the cards separately was
      registered. The latency time, which is determined by the difference between the time spent
      with the responses to the three cards, was used to evaluate selective attention and
      inhibitory control.

      The n-back test was used to evaluate the operational memory. Visual stimuli were used in this
      study, which were represented by colors, divided into three levels (N1, N2, and N3) with 150
      stimuli each. The score of each participant was obtained from the percentage values of the
      hits recorded in the three levels in a computerized version of the test.

      Biochemical analysis Blood samples (10ml) were collected by venose puncture in heparinized
      vacutainer® tubes. Plasma glucose concentration were determined both using a glucose analyzer
      and using standard kit. Total cholesterol, HDL cholesterol and triglycerides were analysed by
      standard methods.

      Inflammatory markers Plasma samples were also used to analyse interleukins 2, 6, 8 and 10 and
      TNFα using standard kits.

      Oxidative stress markers Plasma malondialdehyde (MDA) was determined by high-performance
      liquid chromatography (UV/VIS SPD-20A SHIMADZU, Kioto, Japan) as described by Nielsen et al.
      Thiobarbituric acid reactive substances (TBARS) and Total hydroperoxide (FOX) were assessed
      as plasma lipid peroxidation biomarkers according to method described by Costa et al, and the
      advanced oxidation protein products (AOPP) were based on the method described by Witko-Sarsat
      et al. GSH and GSSG contents were measured using standart kits. Antioxidant enzyme
      activities, superoxide dismutase (SOD) and catalase (CAT) were determined according to Somani
      et al and Aebi, respectively.

      Cardiovascular functions The evaluation of the participants' cardiovascular responses were
      made through the Checking of Resting Blood Pressure with the use of a Sphygmomanometer. All
      measurements were performed with main arm, in triplicate, with patients lying at rest for at
      least 10 minutes. The heart rate were continuously monitored, after the exercise session,
      through a cardiac frequency monitor over an hour, every 10 minutes.

      Autonomic modulation of the cardiovascular system were analyzed by means of the spectral
      analysis of heart rate variability. For this, the individuals were in rest, in the pre- and
      post-exercise moments.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: In the first stage, the participants were initially randomly separated in a double-blind way in order to ingest either the GDP (Condition 1) or maltodextrin as a placebo (Condition 2) for seven days. On the seventh and last day of supplementation, they were submitted to the resistance training session. Before and immediately after the exercise session, the cognitive tests were applied. After these procedures there was a one-week rest period (step 2). Then the procedures performed in the first step were repeated (step 3). However, the group that had received GDP started to receive maltodextrin, and the group who had received maltodextrin started to receive GDP, adopting, thus, a randomized double-blind crossover design.
primary purpose: Other
masking: Double (Participant, Investigator)
masking description: 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.
measure: 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
time frame: Before and immediately after a resistance training session
description: On the seventh day of supplementation all participants did cognitive function tests before and immediately after a resistance training session.
measure: 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
time frame: Before, 1 hour and 2 hours after a resistance training session
description: On the seventh day of supplementation all participants had blood collected before, 1 hour and 2 hours after a resistance training session.
arm group label: Glutamine and exercise
arm group type: Experimental
description: Glutamine 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.
arm group label: Maltodextrin and exercise
arm group type: Placebo Comparator
description: Maltodextrin (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.
intervention type: Dietary Supplement
intervention name: Glutamine and exercise
arm group label: Glutamine and exercise
intervention type: Dietary Supplement
intervention name: Maltodextrin and exercise
arm group label: Maltodextrin and exercise
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ademar Avelar, PhD
role: Principal Investigator
affiliation: University of Maringá
citation: 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: 10383078
citation: Aebi H. Catalase in vitro. Methods Enzymol. 1984;105:121-6. doi: 10.1016/s0076-6879(84)05016-3. No abstract available.
PMID: 6727660
citation: Witko-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: 8731095
citation: Nielsen 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: 9216458
responsible party type: Principal Investigator
investigator affiliation: State University of Maringá
investigator full name: Ademar Avelar de Almeida Junior
investigator title: Principal Investigator
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Metabolic Diseases
sharing ipd: Undecided