Clinical Trials using Tocotrienols

Clinical Trials Title Conclusion Potential Benefits
Hypocholesterolemic Effect of Mixed-Tocotrienols in Hypercholesterolemic Subjects (Kah Hay Yuen, 2011) Supplementation with mixed tocorienols at dose of 300 mg per day resulted in the lowering of the serum total and LDL cholesterol. Reduction of cholesterol level for improvement of general health.
Dose-dependent Modulation of Lipid Parameters, Cytokines and RNA by δ-tocotrienol in Hypercholesterolemic Subjects Restricted to AHA Step-1 Diet (A.A. Qureshi, 2015) The present results confirm that consumption of δ-tocotrienol plus AHA Step-1 diet causes significant reduction in serum lipid parameters and several cytokines (TNF-α, IL-2, IL-4, IL-6, IL-8, IL-10) at low optimal dose (250mg/d). The capacity of δ-tocotrienol to modulate inflammation is partly attributable to dose-dependent properties of inhibition/activation, which may play a major role in future treatment of cardiovascular diseases. Reduction of cholesterol level and improvement in cardiovascular health.
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. Reduction of cholesterol level and improvement in general health, most potent tocotrienol is Gamma-Tocotrienol.
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. Reduction of cholesterol level for improvement of general health.
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. Reduction of cholesterol for improvement of general health.
Neuroprotection 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. Shown to be able to improve brain health.
Carotid Stenosis 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 patient, while none in the control group showed regression and ten of the twenty five showed progression. Improvement in treatment of Carotid Stenosis.
Renal Disease Vitamin E Tocotrienol Supplementation Improves Lipid Profiles in Chronic Hemodylysis Patients ( Zulfitri, 2013) TRF suplementation improved lipid profiles in this study of maintenance hemodylysis patients. The TRF supplemented group showed improvement in lipid profiles after 12 and 16 weeks of intervention when compared with placebo group. Improvement of lipid profile and health of kidney patients.
Non-Alcoholic Fatty Liver Disease (NAFLD) 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). Improvement in health of NAFLD patients.
Immunoresponse 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. Improvement in immunity.
Type 2 Diabetes 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 FBS 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. Improvement in control of health of type 2 diabetes patients with combination of drugs.
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. Useful in treatment and prevention of hyperlipidemia.
Oxidative Stress 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. Reduction of AGEs may slow down degenerative diseases in older adults.

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.
REF: Nesaretnam et al 2010

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
NNT=6 (dropout patients regarded as non-responders)

Ref: Magosso et al, 2010