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Tocotrienol Supplementa as A Senolytic Agent in Middle-aged Adults

4 giugno 2026 aggiornato da: National University of Malaysia

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?

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

220

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 56000
        • Reclutamento
        • National University of Malaysia
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Investigational product (IP)
Participant receiving investigational product at 200mg daily
Integratore alimentare: Treatment
Each participant will receive 200mg/day of tocotrienol-rich fraction capsules divided into two daily doses
Comparatore placebo: Placebo
Participant receiving placebo capsules at 200mg daily
Altro: Placebo
Participant will receive placebo softgel of 200mg divided into two daily doses

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Blood pressure
Lasso di tempo: Baseline, Month 3 and Month 6
Blood pressure in mmHg using Sphygmomanometer
Baseline, Month 3 and Month 6
Changes in Advanced Glycation End Products (AGEs)
Lasso di tempo: Baseline, Month 3, and Month 6
Changes in blood AGEs concentration measured by ELISA will be quantified as circulating glycoxidation markers and expressed in arbitrary units (AU) or µg/mL
Baseline, Month 3, and Month 6
Changes in Protein Carbonyl
Lasso di tempo: Baseline, Month 3, and Month 6
Change in blood protein carbonyl concentration measured by ELISA , will be quantified as nmol carbonyl/mg protein
Baseline, Month 3, and Month 6
Change in Malondialdehyde (MDA)
Lasso di tempo: Baseline, Month 3, and Month 6
Change in blood malondialdehyde concentration measured by high-performance liquid chromatography (HPLC)
Baseline, Month 3, and Month 6
Change in DNA Damage
Lasso di tempo: Baseline, Month 3, and Month 6
Change in blood DNA damage levels measured using validated laboratory assays
Baseline, Month 3, and Month 6
Body Composition assessment
Lasso di tempo: Baseline, Month 3, and Month 6
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
Baseline, Month 3, and Month 6
Food intake questionnaire
Lasso di tempo: Baseline, Month 3, and Month 6
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)
Baseline, Month 3, and Month 6
Changes in SASP Gene expression
Lasso di tempo: Baseline, Month 3, and Month 6
Change in senescence-associated secretory phenotype (SASP) gene expression levels in peripheral blood measured by quantitative real-time polymerase chain reaction (qRT-PCR)
Baseline, Month 3, and Month 6
Change in SASP Protein expression
Lasso di tempo: Baseline, Month 3, and Month 6
Change in senescence-associated secretory phenotype (SASP) protein expression levels in peripheral blood measured using protein array analysis
Baseline, Month 3, and Month 6
Change in Tumor Necrosis Factor-Alpha (TNF-α)
Lasso di tempo: Baseline, Month 3, and Month 6
Change in blood TNF-α concentration measured by enzyme-linked immunosorbent assay (ELISA), qill be quantified in picograms per millilitre (pg/mL).
Baseline, Month 3, and Month 6
Change in Inteleukin-6 (IL-6)
Lasso di tempo: Baseline, Month 3, and Month 6
Change in blood IL-6 concentration measured by enzyme-linked immunosorbent assay (ELISA)
Baseline, Month 3, and Month 6
Change in ATP production
Lasso di tempo: Baseline, Month 3, and Month 6
Change in mitochondrial ATP production in peripheral blood measured using Seahorse analysis
Baseline, Month 3, and Month 6
Change in Mitochondrial Complex V Enzyme Activity
Lasso di tempo: Baseline, Month 3, and Month 6
Change in mitochondrial Complex V enzyme activity measured in peripheral blood samples
Baseline, Month 3, and Month 6
Change in Mitochondrial Membrane Potential
Lasso di tempo: Baseline, Month 3, and Month 6
Changes in mitochondrial membrane potential measured in peripheral blood samples
Baseline, Month 3, and Month 6
Change in Plasma Alpha-Tocotrienol Concentration
Lasso di tempo: Baseline, Month 3, and Month 6
Change in plasma α-tocotrienol concentration measured by HPLC will be quantified in micromoles per litre (µmol/L) or micrograms per millilitre (µg/mL).
Baseline, Month 3, and Month 6
Change in Plasma Gamma- Tocotrienol Concentration
Lasso di tempo: Baseline, Month 3, and Month 6
Change in plasma γ-tocotrienol concentration measured by HPLC will be quantified in micromoles per litre (µmol/L) or micrograms per millilitre (µg/mL).
Baseline, Month 3, and Month 6
Change in Total Plasma Tocotrienol Concentration
Lasso di tempo: Baseline, Month 3, and Month 6
Change in total plasma tocotrienol concentration measured by HPLC will be quantified in micromoles per litre (µmol/L) or micrograms per millilitre (µg/mL).
Baseline, Month 3, and Month 6

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Muscle mass
Lasso di tempo: Baseline and Month 6
Appendicular lean mass in kilograms, kg will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)
Baseline and Month 6
Fat mass
Lasso di tempo: Baseline and Month 6
Fat mass in gram, g will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)
Baseline and Month 6
Bone mineral content (BMC)
Lasso di tempo: Baseline and Month 6
Bone mineral content in gram, g will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)
Baseline and Month 6
Cognitive Function
Lasso di tempo: Baseline and Month 6
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.
Baseline and Month 6
Recall memory function
Lasso di tempo: Baseline and Month 6

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
Baseline and Month 6
Working memory function
Lasso di tempo: Baseline and Month 6
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.
Baseline and Month 6
Change in Pulse Wave Velocity (PWV)
Lasso di tempo: Baseline and Month 6
Change in arterial stiffness assessed by pulse wave velocity using an Arteriograph device, will be recorded in metres per second (m/s)
Baseline and Month 6
Change in Augmentation Index (Aix)
Lasso di tempo: Baseline, and Month 6
Change in arterial wave reflection assessed by augmentation index using an Arteriograph device will be expressed as a percentage (%).
Baseline, and Month 6
Change in Central Blood Pressue
Lasso di tempo: Baseline, and month 6
Change in central blood pressure measured using an Arteriograph device will be measured in millimetres of mercury (mmHg)
Baseline, and month 6
Change in Skin Elasticity
Lasso di tempo: Baseline and month 6
Change in skin elasticity measured using a Cutometer, quantify in Arbitary unit
Baseline and month 6
Change in Skin Hydration
Lasso di tempo: Baseline and month 6
Change in skin hydration measured using a Corneometer, quantify in Arbitary unit
Baseline and month 6
Change in Transepidermal Water Loss
Lasso di tempo: Baseline and Month 6
Change in skin barrier function measured as transepidermal water loss using a Tewameter quantify in Arbitary unit
Baseline and Month 6
Change in Skin Pigmentation
Lasso di tempo: Baseline and Month 6
Change in skin pigmentation measured using a mexameter quantify in Arbitary unit
Baseline and Month 6
Change in sebum secretion
Lasso di tempo: Baseline and Month 6
Change in skin sebum secretion measured using a Sebumeter quantify in Arbitary unit
Baseline and Month 6
Change in Skin Wrinkle and Roughness
Lasso di tempo: Baseline and Month 6
Change in wrinkle and skin roughness parameters measured using a visiocan quantify in Arbitary unit
Baseline and Month 6

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National University of Malaysia

Collaboratori

Malaysia Palm Oil Board
Davos Life Science Pte Ltd

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

31 ottobre 2023

Completamento primario (Effettivo)

19 dicembre 2024

Completamento dello studio (Stimato)

30 gennaio 2027

Date di iscrizione allo studio

Primo inviato

29 dicembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

4 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • UKM PPI/111/8/JEP-2022-676

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

All IPD that underlie results in a publication

Periodo di condivisione IPD

Beginning 1 year after publication and ending 3 years after the publication of results

Criteri di accesso alla condivisione IPD

The Principal Investigator will review the request

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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