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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Nakhon Pathom, Thaïlande, 73170
- Institute of Nutrition, Mahidol University
-
Contact:
- Songdhasn Chinapong, Ph.D.
- Numéro de téléphone: 435 +66 2 800 2380
- E-mail: Songdhasn.chi@mahidol.ac.th
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
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.
Autres noms:
|
|
Expérimental: 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.
Autres noms:
|
|
Comparateur actif: 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.
Autres noms:
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.
|
|
Comparateur 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Blood Lipid Profile
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Concentration of Interleukin-6 (IL-6)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MU-CIRB 2026/016.1401
- 4839189 (Autre subvention/numéro de financement: Program Management Unit for Competitiveness (PMUC))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .