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DyslipidemiaNCT07710261

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

A study testing Policosanol and Concurrent Exercise Training in people with Dyslipidemia and Elevated Blood Lipids, run by Mahidol University at 1 site in Thailand.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 59 years
What is being tested?
Policosanol and Concurrent Exercise Training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteThailand
Study dates
22 Jun 2026to 29 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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;
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Thailand1 site
  • Institute of Nutrition, Mahidol University

    Nakhon Pathom, 73170

    Songdhasn Chinapong, Ph.D., +66 2 800 2380 ext. 435, Songdhasn.chi@mahidol.ac.th

Other trials in Thailand

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Policosanol, Placebo, Concurrent Exercise Training
Keywords
Policosanol, Octacosanol, Dietary Supplement, Concurrent Exercise Training, Aerobic Exercise, Resistance Exercise, Blood Lipid Profile, Muscle Function, Physical Fitness, Dyslipidemia, Nutraceutical
Medical subject headings
Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PolicosanolDietary supplement

    Also called Octacosanol, Sugarcane-derived 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.

  • PlaceboDietary 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.

  • Concurrent Exercise TrainingBehavioural

    Also called Combined aerobic and resistance exercise training, 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.

Study groups in NCT07710261
Study groupRoleWhat they receive
Policosanol Plus Exercise TrainingExperimentalParticipants 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).
Receives: Dietary Supplement: Policosanol; Behavioral: Concurrent Exercise Training
Policosanol AloneExperimentalParticipants 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.
Receives: Dietary Supplement: Policosanol
Placebo Plus Exercise TrainingActive comparatorParticipants 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).
Receives: Dietary Supplement: Placebo; Behavioral: Concurrent Exercise Training
Placebo AlonePlacebo comparatorParticipants in this arm will receive a matching placebo for 12 weeks and will not participate in the structured exercise training program.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, week 6, and week 12

  2. 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.

    Measured: Baseline, week 6, and week 12

  3. 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.

    Measured: Baseline, week 6, and week 12

  4. 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.

    Measured: Baseline, week 6, and week 12

  5. 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.

    Measured: Baseline, week 6, and week 12

Secondary outcomes (7)
  1. Concentration of Interleukin-6 (IL-6)

    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.

    Measured: Baseline, week 6, and week 12

  2. Concentration of Tumor Necrosis Factor-alpha (TNF-α)

    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.

    Measured: Baseline, week 6, and week 12

  3. Concentration of Interleukin-10 (IL-10)

    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.

    Measured: Baseline, week 6, and week 12

  4. Concentration of Interleukin-1 beta (IL-1β)

    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.

    Measured: Baseline, week 6, and week 12

  5. Concentration of Interleukin-1 Receptor Antagonist (IL-1Ra)

    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.

    Measured: Baseline, week 6, and week 12

  6. Concentration of Lactate Dehydrogenase A (LDH-A)

    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.

    Measured: Baseline, week 6, and week 12

  7. Concentration of Serum Coenzyme Q10

    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.

    Measured: Baseline, week 6, and week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2026
  2. Study start22 Jun 2026 (estimated)
  3. Primary completion27 Nov 2026 (estimated)
  4. Study completion29 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07710261
Sponsor's protocol ID
MU-CIRB 2026/016.1401
Other IDs
4839189
Status last verified
Jul 2026
First submitted
2 Jun 2026
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Policosanol and Concurrent Exercise Training in people with Dyslipidemia and Elevated Blood Lipids, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Blood Lipid Profile (time frame: Baseline, week 6, and week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.

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