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Trial record 65 of 576 for:    maltodextrin

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

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ClinicalTrials.gov Identifier: NCT03236532
Recruitment Status : Completed
First Posted : August 2, 2017
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Ademar Avelar de Almeida Junior, State University of Maringá

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.

Condition or disease Intervention/treatment Phase
Glutamine; Metabolic Disorder Physical Activity Dietary Supplement: Glutamine and exercise Dietary Supplement: Maltodextrin and exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
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.
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.
Primary Purpose: Other
Official Title: Impact of Physical Exercise Associated With Glutamine Supplementation in Health Indicators of People Living With HIV/AIDS
Actual Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine

Arm Intervention/treatment
Experimental: Glutamine and exercise
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.
Dietary Supplement: Glutamine and exercise
Placebo Comparator: Maltodextrin and exercise
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.
Dietary Supplement: Maltodextrin and exercise



Primary Outcome Measures :
  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 [ Time Frame: Before and immediately after a resistance training session ]
    On the seventh day of supplementation all participants did cognitive function tests before and immediately after a resistance training session.


Secondary Outcome Measures :
  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 [ Time Frame: Before, 1 hour and 2 hours after a resistance training session ]
    On the seventh day of supplementation all participants had blood collected before, 1 hour and 2 hours after a resistance training session.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03236532


Sponsors and Collaborators
State University of Maringá
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Principal Investigator: Ademar Avelar, PhD University of Maringá

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ademar Avelar de Almeida Junior, Principal Investigator, State University of Maringá
ClinicalTrials.gov Identifier: NCT03236532     History of Changes
Other Study ID Numbers: State University of Maringá
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ademar Avelar de Almeida Junior, State University of Maringá:
HIV/AIDS; Resistance training, supplementation
Additional relevant MeSH terms:
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Metabolic Diseases