Effect of Aerobic Training and Ginkgo Biloba on Lipids Levels in HIV-positive Patients Undergoing Antiretroviral Treatment

NCT ID: NCT06403787

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-04-01

Brief Summary

The administration of antiretroviral drugs (ART) has significantly prolonged the life expectancy of people living with human immunodeficiency virus (HIV) and delayed the progression towards Acquired Immune Deficiency Syndrome (AIDS). However, this has led to the emergence of other conditions, such as dyslipidemia, among individuals undergoing ART. Dyslipidemia is commonly managed with statin therapy, which has not been reported to have pharmacological interactions with ART. Additionally, ginkgo biloba extract (GBS) has been observed to improve blood lipid concentrations, and aerobic exercise training (EXA) interventions have shown positive modifications in these values.

Given this context, the present study aims to investigate the potential positive effects of an aerobic training program and the consumption of ginkgo biloba extract on plasma lipid concentrations in HIV-positive individuals. The study seeks to provide insights into novel strategies for managing dyslipidemia in this population.

Conditions

Human Immunodeficiency Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ginkgo biloba group

This group will assess the effects of aerobic exercise combined with ginkgo biloba extract

Group Type: EXPERIMENTAL

Aerobic exercise + Ginkgo Biloba Extract

Intervention Type: DRUG

12 weeks of intervention for the participants, divided into 3 stages implementing an exercise adaptation period. The adaptation period will span the first 4 weeks of the intervention, during which participants will be brought to an intensity between 50% and 60% of their maximum heart rate (HRmax). From week 5 to 8, the HRmax range will be increased from 60% to 70%, and during the last 4 weeks, it will be maintained at 70% of HRmax combined with 240 mg of LIFE EXTENSION® brand ginkgo biloba extract in 120 mg tablets

Placebo group

Participants in this group will serve as a control to evaluate the effects of aerobic exercise when administered a placebo of calcined magnesia

Group Type: PLACEBO_COMPARATOR

Aerobic exercise + Calcined magnesia (placebo)

Intervention Type: DRUG

12 weeks of intervention for the participants, divided into 3 stages implementing an exercise adaptation period. The adaptation period will span the first 4 weeks of the intervention, during which participants will be brought to an intensity between 50% and 60% of their maximum heart rate (HRmax). From week 5 to 8, the HRmax range will be increased from 60% to 70%, and during the last 4 weeks, it will be maintained at 70% of HRmax combined with calcined magnesia (homogenized to the same weight of ginkgo biloba)

Statins group

In this group, the effects of aerobic exercise along with the administration of atorvastatin will be investigated

Group Type: ACTIVE_COMPARATOR

Aerobic exercise + Atorvastatin

Intervention Type: DRUG

12 weeks of intervention for the participants, divided into 3 stages implementing an exercise adaptation period. The adaptation period will span the first 4 weeks of the intervention, during which participants will be brought to an intensity between 50% and 60% of their maximum heart rate (HRmax). From week 5 to 8, the HRmax range will be increased from 60% to 70%, and during the last 4 weeks, it will be maintained at 70% of HRmax combined with 20 mg of atorvastatin

Interventions

Aerobic exercise + Ginkgo Biloba Extract

12 weeks of intervention for the participants, divided into 3 stages implementing an exercise adaptation period. The adaptation period will span the first 4 weeks of the intervention, during which participants will be brought to an intensity between 50% and 60% of their maximum heart rate (HRmax). From week 5 to 8, the HRmax range will be increased from 60% to 70%, and during the last 4 weeks, it will be maintained at 70% of HRmax combined with 240 mg of LIFE EXTENSION® brand ginkgo biloba extract in 120 mg tablets

Intervention Type: DRUG

Aerobic exercise + Calcined magnesia (placebo)

12 weeks of intervention for the participants, divided into 3 stages implementing an exercise adaptation period. The adaptation period will span the first 4 weeks of the intervention, during which participants will be brought to an intensity between 50% and 60% of their maximum heart rate (HRmax). From week 5 to 8, the HRmax range will be increased from 60% to 70%, and during the last 4 weeks, it will be maintained at 70% of HRmax combined with calcined magnesia (homogenized to the same weight of ginkgo biloba)

Intervention Type: DRUG

Aerobic exercise + Atorvastatin

12 weeks of intervention for the participants, divided into 3 stages implementing an exercise adaptation period. The adaptation period will span the first 4 weeks of the intervention, during which participants will be brought to an intensity between 50% and 60% of their maximum heart rate (HRmax). From week 5 to 8, the HRmax range will be increased from 60% to 70%, and during the last 4 weeks, it will be maintained at 70% of HRmax combined with 20 mg of atorvastatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Ages 18 to 60 years
• Diagnosis of HIV-1 infection
• Receiving antiretroviral therapy with a triple regimen (Biktarvy treatment)
• Undetectable viral load (< 20 copies/mL) for the past 6 months CD4+ level > 200 cells/μL
• Diagnosis of mixed dyslipidemia in the last three months, indicated by:

• Total cholesterol ≥ 200 mg/dL
• HDL cholesterol < 40 mg/dL in men and < 50 mg/dL in women
• LDL cholesterol > 100 mg/dL
• Triglycerides ≥ 150 mg/dL
• Possession of a mobile device or computer with internet access and necessary platforms
• Willingness to participate voluntarily in the study and provide written consent

Exclusion Criteria

• Individuals who develop hypersensitivity or allergy to ginkgo biloba extract
• Failure to attend at least 80% of the physical exercise sessions (equivalent to missing more than 12 sessions)
• Lack of adherence to pharmacological treatment
• Participant's decision to discontinue the intervention

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Raul Soria Rodriguez, PhD

Associate Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raul Soria Rodriguez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guadalajara

Locations

University Center for Health Sciences

Guadalajara, Jalisco, Mexico

Countries

Mexico

Other Identifiers

CI-02922

Identifier Type: -

Identifier Source: org_study_id