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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Nakhon Pathom, Tailândia, 73170
- Institute of Nutrition, Mahidol University
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Contato:
- Songdhasn Chinapong, Ph.D.
- Número de telefone: 435 +66 2 800 2380
- E-mail: Songdhasn.chi@mahidol.ac.th
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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).
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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.
Outros nomes:
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.
Outros nomes:
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Experimental: 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.
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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.
Outros nomes:
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Comparador Ativo: 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).
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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.
Outros nomes:
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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Comparador de Placebo: Placebo Alone
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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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in Blood Lipid Profile
Prazo: Baseline, week 6, and week 12
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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.
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Baseline, week 6, and week 12
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Change in Body Mass Index
Prazo: Baseline, week 6, and week 12
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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.
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Baseline, week 6, and week 12
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Change in Fat Mass
Prazo: Baseline, week 6, and week 12
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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.
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Baseline, week 6, and week 12
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Change in Lean Mass
Prazo: Baseline, week 6, and week 12
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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.
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Baseline, week 6, and week 12
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Change in Physical Fitness
Prazo: Baseline, week 6, and week 12
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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.
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Baseline, week 6, and week 12
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Concentration of Interleukin-6 (IL-6)
Prazo: Baseline, week 6, and week 12
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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.
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Baseline, week 6, and week 12
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Concentration of Tumor Necrosis Factor-alpha (TNF-α)
Prazo: Baseline, week 6, and week 12
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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.
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Baseline, week 6, and week 12
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Concentration of Interleukin-10 (IL-10)
Prazo: Baseline, week 6, and week 12
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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.
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Baseline, week 6, and week 12
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Concentration of Interleukin-1 beta (IL-1β)
Prazo: Baseline, week 6, and week 12
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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.
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Baseline, week 6, and week 12
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Concentration of Interleukin-1 Receptor Antagonist (IL-1Ra)
Prazo: Baseline, week 6, and week 12
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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.
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Baseline, week 6, and week 12
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Concentration of Lactate Dehydrogenase A (LDH-A)
Prazo: Baseline, week 6, and week 12
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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.
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Baseline, week 6, and week 12
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Concentration of Serum Coenzyme Q10
Prazo: Baseline, week 6, and week 12
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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.
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Baseline, week 6, and week 12
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MU-CIRB 2026/016.1401
- 4839189 (Número de outro subsídio/financiamento: Program Management Unit for Competitiveness (PMUC))
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