About this trial
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?
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Treatment
- Placebo
Treatment groups
Sponsors and collaborators
National University of Malaysia
Lead sponsor
Malaysia Palm Oil Board
Collaborator
Davos Life Science Pte Ltd
Collaborator