Elucidating the Effects of Tocotrienol rich Vitamin E on Metabolic Biomarkers in a Pre-diabetes Population in Malaysia.
Elucidating the Effects of Tocotrienol rich Vitamin E on Metabolic Biomarkers in a Pre-diabetes Population in Malaysia.
Monash University Malaysia
80 participants
Feb 1, 2023
Interventional
Conditions
Summary
This is a prospective, multi-centered, randomized, double-blinded ,placebo-controlled study involving patients with prediabetes with a glycemic control between 5.7-6.4% (HbA1c). The primary aim is to establish the potential mechanism of action(s) of the tocotrienol-rich vitamin E on pre-diabetes subjects by assessing levels of HbA1c, insulin resistance and vitamin E .Tocotrienol and tocopherol levels in pre- diabetes population will be measured and compared the Vitamin E isomers levels in normal and diabetes population. Secondly, is to determine whether tocotrienol-rich Vitamin E supplementation at 200mg per day given to pre-diabetes subjects will result in an improvement of insulin resistance and Beta cell function as assessed by the levels of the biomarkers (insulin, resistin, adiponectin and Glut4.) . We hypothesize that Vitamin E supplementation in pre-diabetes population will improve insulin resistance and beta cell function.
Eligibility
Inclusion Criteria4
- Multi-ethnic population in Malaysia namely, Chinese, Malay and Indian who are 40 years and above with high risk of Diabetes Mellitus/Pre-diabetes with a FINDRISC Score of 15 and above i.e. risk of diabetes 33%. (Follow the FINDRISC Model)
- A risk score of 15 to 20 points indicates a high risk of diabetes (33% chance of diabetes over 10 years).
- A risk score of greater than 20 points indicate a very high risk of diabetes (50% chance of diabetes over 10 years).
- Pre-Diabetes criteria: HbA1c: 5.7 to 6.4% (revised)
Exclusion Criteria16
- FINDRISC score lower than 15 and HbA1c greater than 6.5% for pre diabetes, and greater than 8.0% for new diabetes
- Diagnosed diabetes patients for 5 years or more.
- Fluctuating blood sugar level
- unstable glucose control (more than 10% change in HbA1c levels over the last 2 months)
- High blood pressure
- poor blood pressure control, BP greater than 160/100
- Pregnancy
- pregnant during screening
- Breastfeeding mothers
- Known diabetic or non-diabetic kidney disease, such as kidney stones etc.
- Acute or severe chronic illness such as acute coronary syndrome, active tuberculosis, and previous or current history of cancer, liver, or inflammatory disease etc.
- Taking other vitamins such as Vitamin C or A for the past 1 month
- Taking other water-soluble antioxidants for the past 2 weeks or fat-soluble antioxidants for the past 1 month
- Abnormal liver enzyme
- elevated liver enzymes (serum ALT and/or serum AST more than 3 times the upper limit of normal)
- Participants that are below 40 years old and above 75 years old.
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Interventions
Arm 1: 200mg tocotrienol rich Vitamin E from palm oil Dose: 200mg once daily Duration: 3 months Mode of administration: Oral capsule Active ingredients: 1) Gold Tocotrienol E 70% 2) Yellow palm superolein Adherence will be assessed by counting the remaining capsule brought back by the participants during the follow-up visits. In addition, the plasma Vitamin E levels will me measured to assess adherence of the participants.
Locations(2)
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ACTRN12622000256774