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

Mahidol University1 个研究点分布在 1 个国家目标入组 120 人开始时间: 2026年6月22日最近更新: 2026年7月17日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Mahidol University
入组人数: 120
试验地点: 1
主要终点: Change in Blood Lipid Profile

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Factorial
主要目的: Treatment
盲法: Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围: 25 Years 至 59 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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.