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

15 de julio de 2026 actualizado por: Songdhasn Chinapong, Mahidol University

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

120

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Nakhon Pathom, Tailandia, 73170
        • Institute of Nutrition, Mahidol University
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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).
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.
Otros nombres:
  • Octacosanol
  • Sugarcane-derived policosanol
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.
Otros nombres:
  • Entrenamiento de ejercicio
  • Combined aerobic and resistance exercise training
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.
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.
Otros nombres:
  • Octacosanol
  • Sugarcane-derived policosanol
Comparador activo: 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.
Otros nombres:
  • Entrenamiento de ejercicio
  • Combined aerobic and resistance exercise training
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.
Comparador de placebos: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Blood Lipid Profile
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Concentration of Interleukin-6 (IL-6)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

22 de junio de 2026

Finalización primaria (Estimado)

27 de noviembre de 2026

Finalización del estudio (Estimado)

29 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

2 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de julio de 2026

Publicado por primera vez (Actual)

17 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • MU-CIRB 2026/016.1401
  • 4839189 (Otro número de subvención/financiamiento: Program Management Unit for Competitiveness (PMUC))

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .