The Beneficial Effects of SesaVitaTM on Lipid Profiles and Blood Glucose Levels in Subjects With Prediabetes and Mild-To-Moderate Hyperlipidemia in India

H N Shivaprasad,K R Raveendra,G Sushma,M Bhanumathy,Ceyhun Tamer,K Venkateshwarlu

doi:10.5539/jfr.v2n5p104

Abstract

Individuals suffering from Type 2 diabetes develop prediabetes before progression of diabetes. In case of prediabetes people, the blood glucose levels are higher than normal but not sufficient to be diagnosed as diabetes. On the basis of existing reports on Sesame extract, SesaVitaTM which is an herbal food supplement containing Sesame seeds (Sesamum indicum L.) extract may provide an option for management of prediabetes. The objective of this study was to determine the beneficial effects of SesaVitaTM in prediabetes and mild to moderate hyperlipidemia subjects. This randomized, placebo-controlled, double-blind study comprised of 13 female and 07 male patients with prediabetes and mild to moderate hyperlipidemia, aged between 18 and 65 years. Twenty subjects were randomized to receive SesaVitaTM (500 mg/day) or placebo along with therapeutic lifestyle changes for 6 weeks. The primary outcome was the measure of efficacy in terms of change in serum lipid profile and glycaemic levels on week 3 and 6. Secondary outcome measures include safety and tolerability evaluated by physical examination and clinical laboratory evaluations. Improvements in lipid profile and glycaemic levels were observed in SesaVitaTM treated group when compared with placebo and baseline. A statistical significant reduction was observed in low density lipoprotein cholesterol (LDL-C), total cholesterol (TC), oral glucose tolerance test (OGTT) and fasting blood sugar (FBS) levels during week 3 and 6 when treated with SesaVitaTM extract. No adverse events occurred and all safety parameters were within normal ranges during the study. This study revealed that the treatment with SesaVitaTM was safe and well tolerated; may be beneficial in the management of prediabetes and mild-to-moderate hyperlipidemia.

Highlights

Prediabetes, known as intermediate hyperglycaemia, is a high-risk state for diabetes
A statistical significant reduction was observed in low density lipoprotein cholesterol (LDL-C), total cholesterol (TC), oral glucose tolerance test (OGTT) and fasting blood sugar (FBS) levels during week 3 and 6 when treated with SesaVitaTM extract
This study revealed that the treatment with SesaVitaTM was safe and well tolerated; may be beneficial in the management of prediabetes and mild-to-moderate hyperlipidemia

Summary

Introduction

Prediabetes, known as intermediate hyperglycaemia, is a high-risk state for diabetes. It is defined as glycaemic variables that are higher than normal, but lower than the diabetes threshold (Tabák, Herder, Rathmann, Brunner, & Kivimäki, 2012). About 5-10% of people per year with prediabetes will progress to diabetes, with the same proportion converting back to normoglycaemia. Experts have projected that by the year 2030, the prevalence of prediabetes will be more than 470 million people (Tabák, Herder, Rathmann, Brunner, & Kivimäki, 2012). Prediabetes people may suffer from the factors such as hyperlipidemia, hypertension and insulin resistance-linked obesity which increase the risk of heart disease. Simultaneous presence of insulin resistance and β-cell dysfunction-abnormalities were found in prediabetes people that start before glucose changes are www.ccsenet.org/jfr

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