None listed
Conditions
Brief 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.
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.
Sponsors
Monash University Malaysia
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Multi-ethnic population in Malaysia namely, Chinese, Malay, Indian and Orang Asli (indigenous population) 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). 2. Pre-Diabetes criteria: HbA1c: 6.0 to 6.5%. 3. Newly diagnosed diabetes patients ( less than 5 years) with HbA1c equal to 8% and on 2 medications or less and excluding insulin.
Exclusion criteria
1. FINDRISC score lower than 15 and HbA1c greater than 6.5% for pre diabetes, and greater than 8.0% for new diabetes 2. Diagnosed diabetes patients for 5 years or more. 3. Fluctuating blood sugar level • unstable glucose control (more than 10% change in HbA1c levels over the last 2 months) 4. High blood pressure • poor blood pressure control, BP greater than 160/100 5. Pregnancy • pregnant during screening 6. Breastfeeding mothers 7. Known diabetic or non-diabetic kidney disease, such as kidney stones etc. 8. Acute or severe chronic illness such as acute coronary syndrome, active tuberculosis, and previous or current history of cancer, liver, or inflammatory disease etc. 9. Taking other vitamins such as Vitamin C or A for the past 1 month 10. Taking other water-soluble antioxidants for the past 2 weeks or fat-soluble antioxidants for the past 1 month 11. Abnormal liver enzyme • elevated liver enzymes (serum ALT and/or serum AST more than 3 times the upper limit of normal) 12. Participants that are below 40 years old and above 75 years old.
Outcome results
None listed