Effects of Policosanol and Exercise on Fitness and Lipids in People With Elevated Blood Lipids

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Policosanol
  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.
• Пищевая добавка Placebo
  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.
• Поведенческое Concurrent 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.

Первичные конечные точки

• Change in Blood Lipid Profile [Срок оценки: Baseline, week 6, and week 12]
• Change in Body Mass Index [Срок оценки: Baseline, week 6, and week 12]
• Change in Fat Mass [Срок оценки: Baseline, week 6, and week 12]
• Change in Lean Mass [Срок оценки: Baseline, week 6, and week 12]
• Change in Physical Fitness [Срок оценки: Baseline, week 6, and week 12]

Вторичные конечные точки (7)

• Concentration of Interleukin-6 (IL-6) [Срок оценки: Baseline, week 6, and week 12]
• Concentration of Tumor Necrosis Factor-alpha (TNF-α) [Срок оценки: Baseline, week 6, and week 12]
• Concentration of Interleukin-10 (IL-10) [Срок оценки: Baseline, week 6, and week 12]
• Concentration of Interleukin-1 beta (IL-1β) [Срок оценки: Baseline, week 6, and week 12]
• Concentration of Interleukin-1 Receptor Antagonist (IL-1Ra) [Срок оценки: Baseline, week 6, and week 12]
• Concentration of Lactate Dehydrogenase A (LDH-A) [Срок оценки: Baseline, week 6, and week 12]
• Concentration of Serum Coenzyme Q10 [Срок оценки: Baseline, week 6, and week 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Таиланд · 1 центр

• Institute of Nutrition, Mahidol University — Nakhon Pathom

Идентификаторы

NCT: NCT07710261 · MU-CIRB 2026/016.1401 · 4839189

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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