Tocotrienol Supplementa as A Senolytic Agent in Middle-aged Adults

Официальное название

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial Evaluating Tocotrienol-Rich Fraction as a Senolytic Agent in Middle-Aged Adults

Обзор

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.

Вмешательства

• Пищевая добавка Treatment
  Each participant will receive 200mg/day of tocotrienol-rich fraction capsules divided into two daily doses
• Другое Placebo
  Participant will receive placebo softgel of 200mg divided into two daily doses

Первичные конечные точки

• Blood pressure [Срок оценки: Baseline, Month 3 and Month 6]
• Changes in Advanced Glycation End Products (AGEs) [Срок оценки: Baseline, Month 3, and Month 6]
• Changes in Protein Carbonyl [Срок оценки: Baseline, Month 3, and Month 6]
• Change in Malondialdehyde (MDA) [Срок оценки: Baseline, Month 3, and Month 6]
• Change in DNA Damage [Срок оценки: Baseline, Month 3, and Month 6]
• Body Composition assessment [Срок оценки: Baseline, Month 3, and Month 6]
• Food intake questionnaire [Срок оценки: Baseline, Month 3, and Month 6]
• Changes in SASP Gene expression [Срок оценки: Baseline, Month 3, and Month 6]
• Change in SASP Protein expression [Срок оценки: Baseline, Month 3, and Month 6]
• Change in Tumor Necrosis Factor-Alpha (TNF-α) [Срок оценки: Baseline, Month 3, and Month 6]

Вторичные конечные точки (12)

• Muscle mass [Срок оценки: Baseline and Month 6]
• Fat mass [Срок оценки: Baseline and Month 6]
• Bone mineral content (BMC) [Срок оценки: Baseline and Month 6]
• Cognitive Function [Срок оценки: Baseline and Month 6]
• Recall memory function [Срок оценки: Baseline and Month 6]
• Working memory function [Срок оценки: Baseline and Month 6]
• Change in Pulse Wave Velocity (PWV) [Срок оценки: Baseline and Month 6]
• Change in Augmentation Index (Aix) [Срок оценки: Baseline, and Month 6]
• Change in Central Blood Pressue [Срок оценки: Baseline, and month 6]
• Change in Skin Elasticity [Срок оценки: Baseline and month 6]
• Change in Skin Hydration [Срок оценки: Baseline and month 6]
• Change in Transepidermal Water Loss [Срок оценки: Baseline and Month 6]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Малайзия · 1 центр

• National University of Malaysia — Kuala Lumpur

Идентификаторы

NCT: NCT07637487 · UKM PPI/111/8/JEP-2022-676

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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