Tocotrienol Supplementation for Aging Markers in Healthy Middle-Aged Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study tests whether daily tocotrienol (200 mg) can influence aging-related biological pathways in otherwise healthy middle-aged adults. Participants will be randomized to receive either tocotrienol or a placebo for six months, with visits at baseline, 3 months, and 6 months for clinical assessments and laboratory testing. Outcomes include senescence-associated markers, inflammation, oxidative stress, and mitochondrial function, along with safety evaluations. The study compares a tocotrienol-rich fraction against placebo to determine potential effects on aging biomarkers and related health changes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.

Where it's running

• National University of Malaysia
  Kuala Lumpur, Kuala Lumpur, Malaysia Recruiting

Study contacts

• Study coordinator: Suzana Makpol
• Email: suzanamakpol@ukm.edu.my
• Phone: 603-91459554

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.