Tocotrienol Supplementa as A Senolytic Agent in Middle-aged Adults
ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-50
SponsorNational University of Malaysia
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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Treatment
Dietary supplementEach participant will receive 200mg/day of tocotrienol-rich fraction capsules divided into two daily doses
Placebo
Other interventionParticipant will receive placebo softgel of 200mg divided into two daily doses
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Investigational product (IP)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Blood pressure
Blood pressure in mmHg using Sphygmomanometer
Time frame
Baseline, Month 3 and Month 62
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
Time frame
Baseline, Month 3, and Month 63
Changes in Protein Carbonyl
Change in blood protein carbonyl concentration measured by ELISA , will be quantified as nmol carbonyl/mg protein
Time frame
Baseline, Month 3, and Month 64
Change in Malondialdehyde (MDA)
Change in blood malondialdehyde concentration measured by high-performance liquid chromatography (HPLC)
Time frame
Baseline, Month 3, and Month 6Secondary outcomes
1
Muscle mass
Appendicular lean mass in kilograms, kg will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)
Time frame
Baseline and Month 62
Fat mass
Fat mass in gram, g will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)
Time frame
Baseline and Month 63
Bone mineral content (BMC)
Bone mineral content in gram, g will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)
Time frame
Baseline and Month 64
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.
Time frame
Baseline and Month 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National University of Malaysia
Lead sponsor
Malaysia Palm Oil Board
Collaborator
Davos Life Science Pte Ltd
Collaborator
Source ClinicalTrials.gov