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.
Men and women aged 25 to 59 years.
BMI between 18.5 and 29.9 kg/m².
Total cholesterol ≥ 200 mg/dL;
Low-density lipoprotein cholesterol ≥ 130 mg/dL and < 190 mg/dL;
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.
Factorial
Policosanol
Dietary supplementParticipants 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.
Placebo
Dietary supplementParticipants 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.
Concurrent Exercise Training
BehavioralParticipants 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.
Change in Blood Lipid Profile
Blood lipid profile will be assessed using fasting venous blood samples. Parameters will include total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides, measured in mg/dL. Values will be analyzed to determine changes over the 12-week intervention period among the four study groups.
Change in Body Mass Index
Body mass index will be calculated from measured body weight (kg) and height (m) and reported in kg/m². Change in body mass index will be analyzed from baseline to week 12 among the four study groups.
Change in Fat Mass
Fat mass will be assessed using bioelectrical impedance analysis and reported in kg. Change in fat mass will be analyzed from baseline to week 12 among the four study groups.
Change in Lean Mass
Lean mass will be assessed using bioelectrical impedance analysis and reported in kg. Change in lean mass will be analyzed from baseline to week 12 among the four study groups.
Concentration of Interleukin-6 (IL-6)
Serum interleukin-6 (IL-6) concentration will be measured from fasting venous blood samples and reported in pg/mL to evaluate changes in systemic inflammatory responses following the intervention.
Concentration of Tumor Necrosis Factor-alpha (TNF-α)
Serum tumor necrosis factor-alpha (TNF-α) concentration will be measured from fasting venous blood samples and reported in pg/mL to evaluate changes in systemic inflammatory responses following the intervention.
Concentration of Interleukin-10 (IL-10)
Serum interleukin-10 (IL-10) concentration will be measured from fasting venous blood samples and reported in pg/mL to evaluate changes in anti-inflammatory responses following the intervention.
Concentration of Interleukin-1 beta (IL-1β)
Serum interleukin-1 beta (IL-1β) concentration will be measured from fasting venous blood samples and reported in pg/mL to evaluate changes in systemic inflammatory responses following the intervention.
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