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NCT07710261

Effects of Policosanol and Exercise on Fitness and Lipids in People With Elevated Blood Lipids

Sponsor: Mahidol University

View on ClinicalTrials.gov

Summary

This study will evaluate the effects of policosanol supplementation, concurrent exercise training, and their combination on physical fitness, muscle recovery, inflammatory markers, and blood lipid profiles in adults with elevated blood lipids who are not currently indicated for lipid-lowering medication. Participants will be randomly assigned to one of four groups for 12 weeks: policosanol plus exercise training, policosanol alone, placebo plus exercise training, or placebo without structured exercise training. Participants assigned to the supplementation groups will take policosanol 5 mg per day, while those assigned to the placebo groups will take a matching placebo. Participants assigned to the exercise groups will complete a standardized concurrent exercise training program combining aerobic and resistance exercise. The study will compare changes in physical fitness, lipid profiles, and selected blood biomarkers before and after the intervention. The findings may help determine whether low-dose policosanol, alone or combined with exercise training, can support cardiometabolic health and physical fitness in adults with dyslipidemia.

Official title: Effect of Policosanol Supplementation Combined With Concurrent Exercise Training on Physical Fitness and Lipid Profiles in Healthy Volunteers With Elevated Blood Lipid But Not Required Medical Treatment

Key Details

Gender

All

Age Range

25 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-06-22

Completion Date

2027-01-29

Last Updated

2026-07-17

Healthy Volunteers

Conditions

Dyslipidemia Elevated Blood Lipids Physical Fitness Exercise Training Muscle Function, Handgrip Strength Test

Interventions

DIETARY_SUPPLEMENT

Policosanol

Participants assigned to the policosanol intervention will receive policosanol supplementation at a dose of 5 mg per day for 12 weeks. The supplement will be administered orally. This intervention is intended to evaluate the effect of low-dose policosanol on physical fitness, muscle recovery, inflammatory markers, and blood lipid profiles in adults with dyslipidemia.

DIETARY_SUPPLEMENT

Placebo

Participants assigned to the placebo intervention will receive a matching placebo product for 12 weeks. The placebo will be prepared to resemble the policosanol supplement in appearance and will be administered in the same manner. This intervention will serve as the control for policosanol supplementation.

BEHAVIORAL

Concurrent Exercise Training

Participants assigned to the exercise intervention will complete a standardized concurrent exercise training program for 12 weeks. The program will combine aerobic and resistance exercise components and will be performed 3 days per week, approximately 60 minutes per session. This intervention is intended to evaluate the effect of structured exercise training, alone or combined with policosanol supplementation, on physical fitness, muscle recovery, inflammatory markers, and blood lipid profiles.

Inclusion Criteria: * Men and women aged 25 to 59 years. * BMI between 18.5 and 29.9 kg/m². * Diagnosed with or presenting with dyslipidemia within the past 3 months, based on laboratory assessment at baseline or a standard laboratory report issued within the past 3 months, according to the National Cholesterol Education Program Adult Treatment Panel III criteria, defined by at least one of the following: * Total cholesterol ≥ 200 mg/dL; * Low-density lipoprotein cholesterol ≥ 130 mg/dL and \< 190 mg/dL; * High-density lipoprotein cholesterol \< 40 mg/dL in men; * High-density lipoprotein cholesterol \< 50 mg/dL in women; * Triglycerides ≥ 150 mg/dL. * Free from chronic or comorbid conditions that contraindicate participation in aerobic or resistance exercise. * Cleared for physical activity based on the Physical Activity Readiness Questionnaire for Everyone. * Not regularly physically active during the preceding 3 months, defined as fewer than 3 exercise sessions per week or less than 150 minutes of exercise per week. * Able and willing to participate in the study procedures and provide written informed consent. Exclusion Criteria: * Current or recent use within the past 3 months of lipid-lowering medications or dietary supplements known to influence lipid metabolism, including statins, fibrates, niacin, omega-3 fatty acids, red yeast rice, or policosanol. * Known allergy or hypersensitivity to policosanol, sugarcane derivatives, capsule components, or any excipients in the supplement formulation. * Presence of chronic or comorbid conditions that may make exercise participation unsafe, including but not limited to cardiovascular disease, chronic obstructive pulmonary disease, severe arthritis, osteoporosis, uncontrolled diabetes, gastrointestinal disorders, or neurological impairments affecting movement control. * High-risk lifestyle factors, including heavy smoking, excessive alcohol consumption, or use of recreational drugs. Inability to comply with the study protocol, including inability to participate in the exercise program when assigned or inability to attend scheduled follow-up assessments. \- Refusal or inability to provide written informed consent independently.

Locations (1)

Institute of Nutrition, Mahidol University

Nakhon Pathom, Thailand