RecruitingPhase 2ACTRN12622000256774

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.


Sponsor

Monash University Malaysia

Enrollment

80 participants

Start Date

Feb 1, 2023

Study Type

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

Sex: Both males and femalesMin Age: 40 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

Pre-diabetes is a stage where blood sugar levels are higher than normal but not yet high enough to be called type 2 diabetes. Without intervention, many people with pre-diabetes go on to develop full diabetes. Vitamin E — specifically a form called tocotrienol — has shown early promise in improving how the body responds to insulin, but more evidence is needed. This Malaysian study is testing whether taking 200mg per day of tocotrienol-rich Vitamin E supplements helps to improve insulin sensitivity and blood sugar control in people with pre-diabetes. Half of participants will receive the supplement and half will receive a dummy pill (placebo), and neither participants nor researchers will know who received which until the study ends. You may be eligible if you are between 40 and 75 years old, are of Malaysian Chinese, Malay or Indian background, have a pre-diabetes HbA1c reading of 5.7–6.4%, and score 15 or above on a diabetes risk assessment tool. People with established diabetes for 5+ years, poorly controlled blood pressure, pregnancy, serious illness, kidney disease, or who are currently taking other vitamin supplements are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

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)

Kota Damansara, Selangor, Malaysia

Faculty of Medicine and Health Sciences, 43400 UPM Serdang, Selangor Darul Ehsan., Malaysia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12622000256774


Related Trials