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

NCT06403787 | Completed Phase 2

• 1 other identifier: CI-02922
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Keywords

HIV-positive individuals; Aerobic exercise training; Ginkgo biloba extract; Plasma lipid concentrations

Outcome Measures

Primary Outcomes (1)

• Comparison of changes in serum lipid levels.

  Levels of Total Cholesterol (mg/dL), HDL (High-Density Lipoprotein) (mg/dL), LDL (Low-Density Lipoprotein) (mg/dL), VLDL (Very Low-Density Lipoprotein) (mg/dL) and, Triglycerides (mg/dL) will be assessed

  12 weeks

Study Arms (3)

Ginkgo biloba group

EXPERIMENTAL

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

Drug: Aerobic exercise + Ginkgo Biloba Extract

Placebo group

PLACEBO COMPARATOR

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

Drug: Aerobic exercise + Calcined magnesia (placebo)

Statins group

ACTIVE COMPARATOR

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

Drug: Aerobic exercise + Atorvastatin

Interventions

Aerobic exercise + Ginkgo Biloba Extract 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

Ginkgo biloba group

Aerobic exercise + Calcined magnesia (placebo) 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)

Placebo group

Aerobic exercise + Atorvastatin 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

Statins group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

University Center for Health Sciences

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Exercise; Ginkgo biloba extract; Atorvastatin

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Raul Soria Rodriguez, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Professor

Model Details: Double-blind clinical trial with random allocation into three groups, all undergoing aerobic training. One group will receive ginkgo biloba extract, another will be administered atorvastatin, and a third will receive a placebo of calcined magnesia

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 8, 2024
• Study Start: May 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)