Effects of Policosanol and Exercise on Fitness and Lipids in People With Elevated Blood Lipids
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
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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Nakhon Pathom、泰国、73170
- Institute of Nutrition, Mahidol University
-
接触：
- Songdhasn Chinapong, Ph.D.
- 电话号码：435 +66 2 800 2380
- 邮箱：Songdhasn.chi@mahidol.ac.th
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Policosanol Plus Exercise Training
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).
|
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.
其他名称：
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.
其他名称：
|
|
实验性的：Policosanol Alone
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.
|
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.
其他名称：
|
|
有源比较器：Placebo Plus Exercise Training
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).
|
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.
其他名称：
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.
|
|
安慰剂比较：Placebo Alone
Participants in this arm will receive a matching placebo for 12 weeks and will not participate in the structured exercise training program.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Blood Lipid Profile
大体时间：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.
|
Baseline, week 6, and week 12
|
|
Change in Body Mass Index
大体时间：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.
|
Baseline, week 6, and week 12
|
|
Change in Fat Mass
大体时间：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.
|
Baseline, week 6, and week 12
|
|
Change in Lean Mass
大体时间：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.
|
Baseline, week 6, and week 12
|
|
Change in Physical Fitness
大体时间：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.
|
Baseline, week 6, and week 12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Concentration of Interleukin-6 (IL-6)
大体时间：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.
|
Baseline, week 6, and week 12
|
|
Concentration of Tumor Necrosis Factor-alpha (TNF-α)
大体时间：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.
|
Baseline, week 6, and week 12
|
|
Concentration of Interleukin-10 (IL-10)
大体时间：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.
|
Baseline, week 6, and week 12
|
|
Concentration of Interleukin-1 beta (IL-1β)
大体时间：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.
|
Baseline, week 6, and week 12
|
|
Concentration of Interleukin-1 Receptor Antagonist (IL-1Ra)
大体时间：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.
|
Baseline, week 6, and week 12
|
|
Concentration of Lactate Dehydrogenase A (LDH-A)
大体时间：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.
|
Baseline, week 6, and week 12
|
|
Concentration of Serum Coenzyme Q10
大体时间：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.
|
Baseline, week 6, and week 12
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- MU-CIRB 2026/016.1401
- 4839189 (其他赠款/资助编号：Program Management Unit for Competitiveness (PMUC))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.