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Effect of Supplementation With Glutamine and Exercise in Women With HIV/AIDS

Primary Purpose

Glutamine; Metabolic Disorder, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glutamine and exercise
Maltodextrin and exercise
Sponsored by
State University of Maringá
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Glutamine; Metabolic Disorder focused on measuring HIV/AIDS; Resistance training, supplementation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Using the Antiretroviral Therapy (ART) for more than six months;
  • Have a stabilized clinical picture and viral load.

Exclusion Criteria:

  • Physical training programs during the preceding six months;
  • Acute or chronic inflammations that could affect the practice of physical exercise;
  • Psychiatric disorders;
  • Pregnant.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Glutamine and exercise

    Maltodextrin and exercise

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    On the seventh day of supplementation all participants had blood collected before, 1 hour and 2 hours after a resistance training session.

    Full Information

    First Posted
    July 28, 2017
    Last Updated
    August 17, 2017
    Sponsor
    State University of Maringá
    Collaborators
    Conselho Nacional de Desenvolvimento Científico e Tecnológico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03236532
    Brief Title
    Effect of Supplementation With Glutamine and Exercise in Women With HIV/AIDS
    Official Title
    Impact of Physical Exercise Associated With Glutamine Supplementation in Health Indicators of People Living With HIV/AIDS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (Actual)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    State University of Maringá
    Collaborators
    Conselho Nacional de Desenvolvimento Científico e Tecnológico

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glutamine; Metabolic Disorder, Physical Activity
    Keywords
    HIV/AIDS; Resistance training, supplementation

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    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.
    Masking
    ParticipantInvestigator
    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.
    Allocation
    Randomized
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Glutamine and exercise
    Arm Type
    Experimental
    Arm 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 Title
    Maltodextrin and exercise
    Arm Type
    Placebo Comparator
    Arm 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(s)
    Glutamine and exercise
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Maltodextrin and exercise
    Primary Outcome Measure Information:
    Title
    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
    Description
    On the seventh day of supplementation all participants did cognitive function tests before and immediately after a resistance training session.
    Time Frame
    Before and immediately after a resistance training session
    Secondary Outcome Measure Information:
    Title
    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
    Description
    On the seventh day of supplementation all participants had blood collected before, 1 hour and 2 hours after a resistance training session.
    Time Frame
    Before, 1 hour and 2 hours after a resistance training session

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Using the Antiretroviral Therapy (ART) for more than six months; Have a stabilized clinical picture and viral load. Exclusion Criteria: Physical training programs during the preceding six months; Acute or chronic inflammations that could affect the practice of physical exercise; Psychiatric disorders; Pregnant.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ademar Avelar, PhD
    Organizational Affiliation
    University of Maringá
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    10383078
    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.
    Results Reference
    background
    PubMed Identifier
    6727660
    Citation
    Aebi H. Catalase in vitro. Methods Enzymol. 1984;105:121-6. doi: 10.1016/s0076-6879(84)05016-3. No abstract available.
    Results Reference
    background
    PubMed Identifier
    8731095
    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.
    Results Reference
    background
    PubMed Identifier
    9216458
    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.
    Results Reference
    background
    PubMed Identifier
    29850491
    Citation
    de 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.
    Results Reference
    derived

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    Effect of Supplementation With Glutamine and Exercise in Women With HIV/AIDS

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