Clinical Trials using Tocotrienols
|Brain health||› Clinical Investigation of the Protective Effects of Palm Vitamin E Tocotrienols on Brain White Matter (Yogeswaran Gopalan, 2014) |
• Mixed tocotrienols were found to attenuate progression of White Matter Lesions.
› Serum levels of vitamin E forms and risk of cognitive impairment in a Finnish cohort of older adults (Mangialasche et al. 2013)
• Elevated levels of tocopherol and tocotrienol forms are associated with reduced risk of cognitive impairment in older adults. › Tocopherols and tocotrienols plasma levels are associated with cognitive impairment (Mangialasche et al. 2012)
• Compared with cognitively normal subjects, Alzheimer's Disease and mild cognitive impairement had lower levels of total tocopherols, total tocotrienols, and total vitamin E › High plasma level of Vitamin E reduces Alzheimer's disease in advanced age (Mangialasche et al. 2010)
• In conclusion, high plasma levels of vitamin E are associated with a reduced risk of Alzheimer's disease in advanced age.
• The neuroprotective effect of vitamin E seems to be related to the combination of different forms, rather than to α-tocopherol alone, whose efficacy in interventions against AD is currently debated.
|Liver health||› The effect of Vitamin E (mixed tocotrienol) on the liver stiffness measurement (LSM) measured by Transient Elastography (Fibroscan) among NAFLD patients (Arguillas M. et al, 2013)
• Vitamin E (mixed Tocotrienol) 100 mg daily for 3 months could decrease the LSM among NAFLD patients.
› Tocotrienols for Normalization of Hepatic Echogenic Response in Non-alcoholic Fatty Liver: A Randomized Placebo-controlled Clinical Trial (Enrico Magosso, 2013)
• This is the first clinical trial that showed the hepatoprotective effects of mixed palm tocotrienols in hypercholesterolemic adults in Non-Alcoholic Fatty Liver Disease (NAFLD).
› Oral Tocotrienols are trasported to human tissues and delay the progression for Model of End Stage Liver Disease Score in Patients (petal et al, 2012)
• Oral supplementation of TE significantly increased the TE tissue concentrations in blood, skin, adipose, brain, cardiac muscle, and liver over time.
• In prospective liver transplantation patients, oral TE lowered the model for end-stage liver disease (MELD) score in 50% of patients supplemented.
|Cardiovascular health||› Effect of Tocotrienols Enriched Canola Oil on Glycemic Control and Oxidative Status in Patients with Type 2 Diabetes Mellitus: A Randomized Double-blind Placebo-controlled Clinical Trial (Mohammadreza Vafa, 2015)
• Tocotrienols can improve Fasting Blood Sugar concentrations and modify redox balance in T2DM patients with poor glycemic control and can be considered in combination with hypoglycemic drugs to better control of T2DM. › Vitamin E tocotrineol supplementation improves lipids profiles in chronic hemodialysis patients (Daud, Z.A et al, 2013)
• TRF supplementation improved lipid profiles in this study of maintenance hemodialysis patients. › Effect of Mixed-Tocotrienols in Hypercholesterolemic Subjects (Kah Hay Yuen, 2011)
• Supplementation with mixed tocotrienols at a dose of 300 mg per day resulted in the lowering of the serum total and LDL cholesterol.
› Tocotrienol Rich Fraction Supplementation Improved Lipid Profile and Oxidative Status in Healthy Older Adults: A Randomized Controlled Study (Chin, 2011)
• The observed improvement of plasma cholesterol, Advanced Glycation End (AGEs) products and antioxidant vitamin levels as well as the reduced protein damage may indicate a restoration of redox balance after TRF supplementation, particularly in individuals over 50 years of age. › The Therapeutic Impacts of Tocotrienols in Type 2 Diabetic Patients with Hyperlipidemia (Baliarsingh, 2005)
• Daily intake of dietary TRF by type 2 diabetics will be useful in the prevention and treatment of hyperlipidemia and atherogenesis. '' Lowering of Serum Cholesterol in Hypercholesterolemic Humans by Tocotrienols (PalmVitee) (A.A. Qureshi, 1991)
• This indicates that γ-tocotrienol may be the most potent cholesterol inhibitor in Palm Tocotrienol Capsules. '' Response of Hypercholesterolemic Subjects to Administration of Tocotrienols (A.A. Qureshi, 1995)
• Cholesterol level of the 16 subjects in the second group decreased 13% during the four-week trial. › Antioxidant Effects of Tocotrienols in Patients with Hyperlipidermia and Carotid Stenosis(A.C.Tomeo, 1995)
• Bilateral duplex ultrasonography revealed apparent carotid atherosclerosis regression in seven and progression in two of the twenty five tocotrienols patients, while none in the control group showed regression and ten of the twenty five showed progression.
• Findings suggest that antioxidants, such as tocotrienols, may influence the course of carotid atherosclerosis. › Effect of a Palm-Oil Vitamin E Concentrate on the Serum and Lipoprotein Lipids in Humans (Tan DT, 1991)
• The results show that the Palm Tocotrienol Capsules has a hypocholesterolemic effect.
|General health||› Comparing the effects of vitamin E tocotrienol-rich fraction supplementation and α-tocopherol supplementation on gene expression in healthy older adults (Abdul Ghani SM et al, 2019)
• Supplementation with either α-tocopherol or tocotrienol-rich fraction affected the immune and drug response and the cell adhesion and signal transduction pathways but modulated other pathways differently after 6 months of supplementation, with sex-specific responses.
› Effects of Supplementation with Tocotrienol Rich Fraction on Immune Response to Tetanus Toxoid Immunization in Normal Healthy Volunteers (D. Mahalingam, 2010)
• The results conclude that TRF has immunostimulatory effects and potential clinical benefits to enhance immune response to vaccines.
|Photoprotection||› Clinical evalution of photoprotective effect by a topical antioxidants combination (tocopherols and tocotrrienols) (Pedrelli et al, 2011)
• The use of a new topical formulation containing significant concentrations of tocotrienols and tocopherols represents a promising strategy to reduce the photo-induced skin damage
|Anti-oxidant||› Tocotrienol Rich Fraction Supplementation Improved Lipid Profile and Oxidative Status in Healthy Older Adults: A Randomized Controlled Study (Chin, 2011)
• The observed improvement of plasma cholesterol, Advanced Glycation End (AGEs) products and antioxidant vitamin levels as well as the reduced protein damage may indicate a restoration of redox balance after TRF supplementation, particularly in individuals over 50 years of age.
› Effects of Tocotrienol Supplementation on Hair Growth in Human Volunteers (Lim et al, 2010)
• In conclusion, this trial demonstrated that supplementation with tocotrienol capsules increases hair number in volunteers suffering from hair loss as compared to the placebo group.
• This observed effect was most likely to be due to the antioxidant activity of tocotrienols that helped to reduce lipid peroxidation and oxidative stress in the scalp, which are reported to be associated with alopecia
Numbers Needed to Treat (NNT)
5 year Clinical Trial of Tocotrienols & Tamoxifen on Breast Cancer in Women
- The risk of dying decreased by 70% in the group taking Tocotrienols with Tamoxifen as compared with the group taking Placebo with Tamoxifen.
- The risk of reoccurence was 20% lower in the group taking Tocotrienols with Tamoxifen as compared with the group taking Placebo with Tamoxifen.
- The synergic effect of Tocotrienols and Tamoxifen proven
- The NNT=30 to prevent one person from dying.
Clinical Study - Results after 1 year Amelioration of NAFLD
- Of the 64 participants that completed the trial:-
- Tocotrienols found to have significant Hepatoprotective activity compared to Placebo.
- Improved 67% of subjects (NNT = 3.9)
- Cured 50% of subjects (NNT = 3.8)
- Placebo group (N = 34)
- 14 Improved
- 8 Normalized (23%)
- 2 Worsened
- Tocotrienol group (N = 30)
- 20 Improved
- 15 Normalized (50%)
- 0 Worsened