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

NCT07710261 | Not Yet Recruiting

• 2 other identifiers: MU-CIRB 2026/016.14014839189
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dyslipidemia; Elevated Blood Lipids; Physical Fitness; Exercise Training; Muscle Function, Handgrip Strength Test

Keywords

Policosanol; Octacosanol; Dietary Supplement; Concurrent Exercise Training; Aerobic Exercise; Resistance Exercise; Blood Lipid Profile; Muscle Function; Physical Fitness; Dyslipidemia; Nutraceutical

Outcome Measures

Primary Outcomes (5)

• Change in Blood Lipid Profile

  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

  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

  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

  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

  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

Secondary Outcomes (7)

• Concentration of Interleukin-6 (IL-6)

  Baseline, week 6, and week 12

• Concentration of Tumor Necrosis Factor-alpha (TNF-α)

  Baseline, week 6, and week 12

• Concentration of Interleukin-10 (IL-10)

  Baseline, week 6, and week 12

• Concentration of Interleukin-1 beta (IL-1β)

  Baseline, week 6, and week 12

• Concentration of Interleukin-1 Receptor Antagonist (IL-1Ra)

  Baseline, week 6, and week 12

Study Arms (4)

Policosanol Plus Exercise Training

EXPERIMENTAL

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).

Dietary Supplement: Policosanol; Behavioral: Concurrent Exercise Training

Policosanol Alone

EXPERIMENTAL

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.

Dietary Supplement: Policosanol

Placebo Plus Exercise Training

ACTIVE COMPARATOR

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).

Dietary Supplement: Placebo; Behavioral: Concurrent Exercise Training

Placebo Alone

PLACEBO COMPARATOR

Participants in this arm will receive a matching placebo for 12 weeks and will not participate in the structured exercise training program.

Dietary Supplement: Placebo

Interventions

Policosanol DIETARY_SUPPLEMENT

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.

Also known as: Octacosanol, Sugarcane-derived policosanol

Policosanol Alone; Policosanol Plus Exercise Training

Placebo DIETARY_SUPPLEMENT

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.

Placebo Alone; Placebo Plus Exercise Training

Concurrent Exercise Training BEHAVIORAL

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.

Also known as: Combined aerobic and resistance exercise training, Exercise training

Placebo Plus Exercise Training; Policosanol Plus Exercise Training

Eligibility Criteria

• Age: 25 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Institute of Nutrition, Mahidol University

Nakhon Pathom, 73170, Thailand

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

policosanol; 1-octacosanol; Exercise

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This study uses a 2 × 2 factorial, randomized, placebo-controlled, parallel-group design to evaluate the independent and combined effects of policosanol supplementation and concurrent exercise training. Participants will be assigned to one of four intervention groups: policosanol plus exercise training, policosanol alone, placebo plus exercise training, or placebo without structured exercise training. The intervention period will last 12 weeks.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: July 17, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): November 27, 2026
• Study Completion (Estimated): January 29, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

TH (1)