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HealthyNCT07637487

Tocotrienol Supplementa as A Senolytic Agent in Middle-aged Adults

A study testing Treatment in people with Healthy, run by National University of Malaysia at 1 site in Malaysia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to determine whether tocotrienol works as a senolytic agent to delay age-related biological changes in middle-aged adults. The study will also evaluate the safety of tocotrienol supplementation. Read more about this study

Who is it for?
Ages 35 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Treatment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
220 participants
Where
1 siteMalaysia
Study dates
31 Oct 2023to 30 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 35 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Generally healthy as assessed by physical examination and blood lab test, including adequate liver and renal function, Neutrophil count > 1500/mm3, Platelet count 120,000 - 450,000/mm3, Haemoglobin concentration 11.5 to 19.0g/dL for men; 10.5-17.5 g/dL for women, Prothrombin and partial thromboplastin time within normal range, ALT and AST < 80 IU/L, Creatinine 0.7 to 1.3 mg/dL
  • Subject of either gender, 35 to 64 years of age (inclusive)
  • Not allergy to palm oil and vitamin E
  • Do not take vitamin E supplements over the past 3 months
  • Provide written informed consent prior to screening
  • Subject is willing and able to comply with the study visit schedule and procedure, geographic proximity (investigator's discretion) that allows adequate follow up
  • Subjects understand the study protocol and signed informed consent forms

Who cannot join

  • Subjects with fat malabsorption
  • Subjects with chronic conditions such as cardiac diseases (heart failure, myocardial infraction, ischemic heart disease), neurological diseases, diabetes, HIV infection, psychiatric illness/social situations
  • Subjects with vegan diet
  • Current smoker or used to smoke in the past 3 months
  • Subject for surgery or had undergone surgery in the past 3 months
  • Current or past history of drug, alcohol abuse and cancer
Show all 11Show fewer
  • Pregnant and lactating women
  • History of bleeding tendencies or any condition predisposing to bleeding e.g. thrombocytopenia, abnormal liver function, liver disease (e.g. chronic hepatitis), gastrointestinal ulcers
  • Any subject taking antibiotics or other medication or dietary supplement which could interfere with the action of tocotrienols
  • Subjects who are pre-disposed to inherited blood/circulation disorders
  • Subject who is taking anticoagulants and antithrombotic drugs, e.g. warfarin, aspirin, ticlopidine, heparin, etc.

Trial locations and contacts

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

Malaysia1 site, 1 recruiting
  • National University of Malaysia

    Kuala Lumpur, Kuala Lumpur, 56000

    Suzana Makpol, 603-91459554, suzanamakpol@ukm.edu.my

    Recruiting

Other trials in Malaysia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial Evaluating Tocotrienol-Rich Fraction as a Senolytic Agent in Middle-Aged Adults

The goal of this clinical trial is to determine whether tocotrienol works as a senolytic agent to delay age-related biological changes in middle-aged adults. The study will also evaluate the safety of tocotrienol supplementation. The main questions it aims to answer are:

Does tocotrienol reduce markers of cellular senescence, inflammation, oxidative stress, and mitochondrial dysfunction?

Read more

What health changes or medical issues occur in participants taking tocotrienol?

Researchers will compare tocotrienol-rich fraction to a placebo (a look-alike capsule with no active ingredient) to determine whether tocotrienol is effective in modulating aging-related pathways.

Participants will:

Take tocotrienol (200 mg/day) or a placebo daily for 6 months

Attend study visits at baseline, 3 months, and 6 months for clinical assessments and laboratory tests

Undergo blood sampling and health evaluations, including measures of senescence-associated secretory phenotype (SASP), inflammation, oxidative stress, mitochondrial function, vascular health, skin status, cognitive function, body composition, and bone mineral density.

Complete questionnaires related to diet throughout the study period

This study aims to provide clinical evidence on the potential of tocotrienol as a senolytic intervention for promoting healthy aging and reducing the risk of age-related diseases.

Conditions
Healthy
Being tested
Treatment, Placebo

What participants receive

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

  • TreatmentDietary supplement

    Each participant will receive 200mg/day of tocotrienol-rich fraction capsules divided into two daily doses

  • PlaceboOther

    Participant will receive placebo softgel of 200mg divided into two daily doses

Study groups in NCT07637487
Study groupRoleWhat they receive
Investigational product (IP)ExperimentalParticipant receiving investigational product at 200mg daily
Receives: Dietary Supplement: Treatment
PlaceboPlacebo comparatorParticipant receiving placebo capsules at 200mg daily
Receives: Other: Placebo

What is being measured

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

  1. Blood pressure

    Blood pressure in mmHg using Sphygmomanometer

    Measured: Baseline, Month 3 and Month 6

  2. Changes in Advanced Glycation End Products (AGEs)

    Changes in blood AGEs concentration measured by ELISA will be quantified as circulating glycoxidation markers and expressed in arbitrary units (AU) or µg/mL

    Measured: Baseline, Month 3, and Month 6

  3. Changes in Protein Carbonyl

    Change in blood protein carbonyl concentration measured by ELISA , will be quantified as nmol carbonyl/mg protein

    Measured: Baseline, Month 3, and Month 6

  4. Change in Malondialdehyde (MDA)

    Change in blood malondialdehyde concentration measured by high-performance liquid chromatography (HPLC)

    Measured: Baseline, Month 3, and Month 6

  5. Change in DNA Damage

    Change in blood DNA damage levels measured using validated laboratory assays

    Measured: Baseline, Month 3, and Month 6

  6. Body Composition assessment

    Measured using Inbody 770 Analyzer at Physiology Department; BMI (kg/m²) calculated from weight (kg) and height (m); Body fat percentage (%); visceral fate (cm²); basal metabolic rate (kcal); waist to hip ratio

    Measured: Baseline, Month 3, and Month 6

  7. Food intake questionnaire

    Food frequency questionnaires (FFQ) will be completed by the participants, and analyse through Diet Information Management System; Result reported for carbohydrate (g), Cholesterol (mg), Energy (kcal), Fat (g), Fibre (g), Protein (g), vitamin E (mg), water (g)

    Measured: Baseline, Month 3, and Month 6

  8. Changes in SASP Gene expression

    Change in senescence-associated secretory phenotype (SASP) gene expression levels in peripheral blood measured by quantitative real-time polymerase chain reaction (qRT-PCR)

    Measured: Baseline, Month 3, and Month 6

  9. Change in SASP Protein expression

    Change in senescence-associated secretory phenotype (SASP) protein expression levels in peripheral blood measured using protein array analysis

    Measured: Baseline, Month 3, and Month 6

  10. Change in Tumor Necrosis Factor-Alpha (TNF-α)

    Change in blood TNF-α concentration measured by enzyme-linked immunosorbent assay (ELISA), qill be quantified in picograms per millilitre (pg/mL).

    Measured: Baseline, Month 3, and Month 6

  11. Change in Inteleukin-6 (IL-6)

    Change in blood IL-6 concentration measured by enzyme-linked immunosorbent assay (ELISA)

    Measured: Baseline, Month 3, and Month 6

  12. Change in ATP production

    Change in mitochondrial ATP production in peripheral blood measured using Seahorse analysis

    Measured: Baseline, Month 3, and Month 6

  13. Change in Mitochondrial Complex V Enzyme Activity

    Change in mitochondrial Complex V enzyme activity measured in peripheral blood samples

    Measured: Baseline, Month 3, and Month 6

  14. Change in Mitochondrial Membrane Potential

    Changes in mitochondrial membrane potential measured in peripheral blood samples

    Measured: Baseline, Month 3, and Month 6

  15. Change in Plasma Alpha-Tocotrienol Concentration

    Change in plasma α-tocotrienol concentration measured by HPLC will be quantified in micromoles per litre (µmol/L) or micrograms per millilitre (µg/mL).

    Measured: Baseline, Month 3, and Month 6

  16. Change in Plasma Gamma- Tocotrienol Concentration

    Change in plasma γ-tocotrienol concentration measured by HPLC will be quantified in micromoles per litre (µmol/L) or micrograms per millilitre (µg/mL).

    Measured: Baseline, Month 3, and Month 6

  17. Change in Total Plasma Tocotrienol Concentration

    Change in total plasma tocotrienol concentration measured by HPLC will be quantified in micromoles per litre (µmol/L) or micrograms per millilitre (µg/mL).

    Measured: Baseline, Month 3, and Month 6

Secondary outcomes (15)
  1. Muscle mass

    Appendicular lean mass in kilograms, kg will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)

    Measured: Baseline and Month 6

  2. Fat mass

    Fat mass in gram, g will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)

    Measured: Baseline and Month 6

  3. Bone mineral content (BMC)

    Bone mineral content in gram, g will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)

    Measured: Baseline and Month 6

  4. Cognitive Function

    The assessment instrument, the Montreal Cognitive Assessment (MoCA) test will be administered. The evaluation involves assessing participants through questions and instructions covering executive and spatial cognitive domains. The maximum score is 30. A score of 26 and above indicates no cognitive impairment.

    Measured: Baseline and Month 6

  5. Recall memory function

    The Rey Auditory Verbal Learning Test (RAVLT) will be utilized. the RAVLT includes two distinct word lists (A and B). Participants will recall the items from list A over five trials (Memory A1 to A5). Following this, an interference list (list B), comprising 15 unrelated nouns, will be introduced, and participants will attempt to recall as many words as possible from it. Subsequently, participants will be asked to recall the words from list A (Delayed recall/memory A6) without the examiner repeating the list. The number of correctly recalled words for each trial will be totaled to generate a score.

    Total Learning Score (Sum of Trials A1-A5) to indicate normal performance: 45-65, Mild Cognitive impairment: 30-45, dementia: below 30. For delayed recall score (M6), to indicate normal performance: ≥8-12 words recalled, Mild Cognitive Impairment: 4-7 words recalled, and dementia: ≤3 words recalled

    Measured: Baseline and Month 6

  6. Working memory function

    The Digit Span Test involves recalling numbers in the same order (forward), reverse order (backward), or ascending order (sequencing). The test starts with short sequences and increases in length to assess memory capacity. A higher score (20 - 30) indicates better cognitive function, while a lower score (0 - 19) may suggest attention or memory issues. The total score is 30.

    Measured: Baseline and Month 6

  7. Change in Pulse Wave Velocity (PWV)

    Change in arterial stiffness assessed by pulse wave velocity using an Arteriograph device, will be recorded in metres per second (m/s)

    Measured: Baseline and Month 6

  8. Change in Augmentation Index (Aix)

    Change in arterial wave reflection assessed by augmentation index using an Arteriograph device will be expressed as a percentage (%).

    Measured: Baseline, and Month 6

  9. Change in Central Blood Pressue

    Change in central blood pressure measured using an Arteriograph device will be measured in millimetres of mercury (mmHg)

    Measured: Baseline, and month 6

  10. Change in Skin Elasticity

    Change in skin elasticity measured using a Cutometer, quantify in Arbitary unit

    Measured: Baseline and month 6

  11. Change in Skin Hydration

    Change in skin hydration measured using a Corneometer, quantify in Arbitary unit

    Measured: Baseline and month 6

  12. Change in Transepidermal Water Loss

    Change in skin barrier function measured as transepidermal water loss using a Tewameter quantify in Arbitary unit

    Measured: Baseline and Month 6

  13. Change in Skin Pigmentation

    Change in skin pigmentation measured using a mexameter quantify in Arbitary unit

    Measured: Baseline and Month 6

  14. Change in sebum secretion

    Change in skin sebum secretion measured using a Sebumeter quantify in Arbitary unit

    Measured: Baseline and Month 6

  15. Change in Skin Wrinkle and Roughness

    Change in wrinkle and skin roughness parameters measured using a visiocan quantify in Arbitary unit

    Measured: Baseline and Month 6

Timeline

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

  1. First posted9 Jun 2026
  2. Study start31 Oct 2023
  3. Primary completion19 Dec 2024
  4. Study completion30 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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07637487
Sponsor's protocol ID
UKM PPI/111/8/JEP-2022-676
Status last verified
Jun 2026
First submitted
29 Dec 2025
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

A study testing Treatment in people with Healthy, run by National University of Malaysia at 1 site in Malaysia.

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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 9 Jun 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 Malaysia. 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?

Contact Suzana Makpol (603-91459554, suzanamakpol@ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood pressure (time frame: Baseline, Month 3 and Month 6). The study lists 17 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 9 Jun 2026.

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