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| ID | Type | Description | Link |
|---|---|---|---|
| 4839189 | Other Grant/Funding Number | Program Management Unit for Competitiveness (PMUC) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Policosanol Plus Exercise Training | Experimental | Participants in this arm will receive policosanol supplementation at a dose of 5 mg per day for 12 weeks and will participate in a standardized concurrent exercise training program combining aerobic and resistance exercise (3 days per week). |
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| Policosanol Alone | Experimental | Participants in this arm will receive policosanol supplementation at a dose of 5 mg per day for 12 weeks and will not participate in the structured exercise training program. |
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| Placebo Plus Exercise Training | Active Comparator | Participants in this arm will receive a matching placebo for 12 weeks and will participate in a standardized concurrent exercise training program combining aerobic and resistance exercise (3 days per week). |
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| Placebo Alone | Placebo Comparator | Participants in this arm will receive a matching placebo for 12 weeks and will not participate in the structured exercise training program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Policosanol | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, week 6, and week 12 |
| 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. | Baseline, week 6, and week 12 |
| 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. | Baseline, week 6, and week 12 |
| 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. | Baseline, week 6, and week 12 |
| Change in Physical Fitness | 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. | Baseline, week 6, and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, week 6, and week 12 |
| Concentration of Tumor Necrosis Factor-alpha (TNF-α) |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Nutrition, Mahidol University | Nakhon Pathom | 73170 | Thailand |
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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.
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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.
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| Placebo | Dietary Supplement | 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. |
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| Concurrent Exercise Training | Behavioral | 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. |
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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. |
| Baseline, week 6, and week 12 |
| 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. | Baseline, week 6, and week 12 |
| 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. | Baseline, week 6, and week 12 |
| Concentration of Interleukin-1 Receptor Antagonist (IL-1Ra) | 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. | Baseline, week 6, and week 12 |
| Concentration of Lactate Dehydrogenase A (LDH-A) | 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. | Baseline, week 6, and week 12 |
| Concentration of Serum Coenzyme Q10 | 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. | Baseline, week 6, and week 12 |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C080710 | policosanol |
| C044309 | 1-octacosanol |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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