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Tocotrienol Supplementa as A Senolytic Agent in Middle-aged Adults

4. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

220

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 56000
        • Rekrutierung
        • National University of Malaysia
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Investigational product (IP)
Participant receiving investigational product at 200mg daily
Nahrungsergänzungsmittel: Treatment
Each participant will receive 200mg/day of tocotrienol-rich fraction capsules divided into two daily doses
Placebo-Komparator: Placebo
Participant receiving placebo capsules at 200mg daily
Sonstiges: Placebo
Participant will receive placebo softgel of 200mg divided into two daily doses

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Blood pressure
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Muscle mass
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline and month 6
Change in skin elasticity measured using a Cutometer, quantify in Arbitary unit
Baseline and month 6
Change in Skin Hydration
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline and Month 6
Change in skin pigmentation measured using a mexameter quantify in Arbitary unit
Baseline and Month 6
Change in sebum secretion
Zeitfenster: 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
Zeitfenster: Baseline and Month 6
Change in wrinkle and skin roughness parameters measured using a visiocan quantify in Arbitary unit
Baseline and Month 6

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National University of Malaysia

Mitarbeiter

Malaysia Palm Oil Board
Davos Life Science Pte Ltd

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

31. Oktober 2023

Primärer Abschluss (Tatsächlich)

19. Dezember 2024

Studienabschluss (Geschätzt)

30. Januar 2027

Studienanmeldedaten

Zuerst eingereicht

29. Dezember 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Juni 2026

Zuerst gepostet (Tatsächlich)

9. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • UKM PPI/111/8/JEP-2022-676

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

All IPD that underlie results in a publication

IPD-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

The Principal Investigator will review the request

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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