Dyslipidemia, Elevated Blood Lipids, Exercise Training, Muscle Function, Handgrip Strength Test, Physical Fitness
Conditions
Keywords
Policosanol, Octacosanol, Dietary Supplement, Concurrent Exercise Training, Aerobic Exercise, Resistance Exercise, Blood Lipid Profile, Muscle Function, Physical Fitness, Dyslipidemia, Nutraceutical
Brief 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.
Detailed description
This clinical trial is designed to examine whether low-dose policosanol supplementation, alone or in combination with concurrent exercise training, can improve physical fitness, muscle recovery, inflammatory responses, and blood lipid profiles in adults with dyslipidemia who are not currently indicated for lipid-lowering medication. Dyslipidemia is an important modifiable risk factor for cardiovascular disease. Lifestyle modification, including regular exercise, is commonly recommended for individuals with elevated blood lipids before pharmacological treatment is required. Policosanol, a mixture of long-chain aliphatic alcohols mainly derived from plant waxes, has been investigated for its potential effects on lipid metabolism, inflammation, oxidative stress, and exercise-related fatigue. The potential additive effect of combining low-dose policosanol with structured exercise training remains insufficiently established. This study will compare the independent and combined effects of policosanol supplementation and concurrent exercise training over a 12-week intervention period. The exercise program is designed to integrate aerobic and resistance exercise components. Participants will be assessed at baseline and after the intervention period to determine changes in physical fitness, lipid-related outcomes, and selected biochemical markers related to inflammation and skeletal muscle function. The study is expected to provide evidence on whether a low dose of policosanol that is regulatory-acceptable (Thai FDA) can be used as an adjunct to exercise training to support cardiometabolic health, physical fitness, and muscle recovery in adults with elevated blood lipid levels. Findings may contribute to future nutrition and exercise recommendations for adults with early-stage dyslipidemia who are not yet receiving lipid-lowering medication.
Interventions
DIETARY_SUPPLEMENTPolicosanol
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_SUPPLEMENTPlacebo
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.
BEHAVIORALConcurrent 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.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants and investigators will be blinded to the assignment of policosanol or placebo. The policosanol and placebo products will be prepared to be identical in appearance and administered in the same manner. Due to the nature of the exercise intervention, participants and personnel involved in exercise instruction cannot be blinded to exercise training allocation. Outcome assessors will be blinded to supplementation assignment.
Intervention model description
This study uses a 2 × 2 factorial, randomized, placebo-controlled, parallel-group design to evaluate the independent and combined effects of policosanol supplementation and concurrent exercise training. Participants will be assigned to one of four intervention groups: policosanol plus exercise training, policosanol alone, placebo plus exercise training, or placebo without structured exercise training. The intervention period will last 12 weeks.
Eligibility
Sex/Gender
ALL
Age
25 Years to 59 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Lipid Profile | Baseline, week 6, and week 12 | 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 | Baseline, week 6, and week 12 | 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 | Baseline, week 6, and week 12 | 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 | Baseline, week 6, and week 12 | 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. |
| Change in Physical Fitness | Baseline, week 6, and week 12 | Physical fitness will be assessed using endurance capacity and muscular strength tests. Endurance capacity will be evaluated using the YMCA 3-Minute Step Test. Muscular strength will be assessed using a VALD DynaMo handheld dynamometer, including upper-body grip strength and lower-body isometric strength testing. Values will be analyzed to determine changes over the 12-week intervention period among the four study groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Interleukin-6 (IL-6) | Baseline, week 6, and week 12 | 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) | Baseline, week 6, and week 12 | 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) | Baseline, week 6, and week 12 | 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) | Baseline, week 6, and week 12 | 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. |
| Concentration of Interleukin-1 Receptor Antagonist (IL-1Ra) | Baseline, week 6, and week 12 | Serum interleukin-1 receptor antagonist (IL-1Ra) 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 Lactate Dehydrogenase A (LDH-A) | Baseline, week 6, and week 12 | Serum lactate dehydrogenase A (LDH-A) concentration will be measured from fasting venous blood samples and reported in U/L as a biomarker of muscle tissue response following the intervention. |
| Concentration of Serum Coenzyme Q10 | Baseline, week 6, and week 12 | Serum coenzyme Q10 concentration will be measured from venous blood samples using an enzyme-linked immunosorbent assay. Values will be analyzed to determine changes over the 12-week intervention period among the four study groups reported in µg/mL. |
Countries
Thailand
Outcome results
None listed