NCT03236532

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

2 months

First QC Date

July 28, 2017

Last Update Submit

August 17, 2017

Conditions

Keywords

HIV/AIDS; Resistance training, supplementation

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

EXPERIMENTAL

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

Maltodextrin and exercise

PLACEBO COMPARATOR

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

Interventions

Glutamine and exerciseDIETARY_SUPPLEMENT
Glutamine and exercise
Maltodextrin and exerciseDIETARY_SUPPLEMENT
Maltodextrin and exercise

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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: 10383078BACKGROUND
  • Aebi H. Catalase in vitro. Methods Enzymol. 1984;105:121-6. doi: 10.1016/s0076-6879(84)05016-3. No abstract available.

    PMID: 6727660BACKGROUND
  • 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: 8731095BACKGROUND
  • 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: 9216458BACKGROUND
  • 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.

MeSH Terms

Conditions

Metabolic DiseasesMotor ActivityAcquired Immunodeficiency Syndrome

Interventions

GlutamineExercisemaltodextrin

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesBehaviorHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, NeutralMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ademar Avelar, PhD

    University of Maringá

    PRINCIPAL INVESTIGATOR

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
Model Details: 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.
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