STUDY OF SELECTED NUTRACEUTICALS ON MANAGEMENT OF TYPE-2 DIABETES

Abstract

Background: Diabetes mellitus has spread as a pandemic on the globe, over the last few decades, with no geographical, cultural and economic bounds. Life style has emerged as the causative factor and its modification coupled with dietary intervention are the mainstay in its management. Recently the use of nutraceuticals has become popular alternative for the chronic diseases particularly diabetes. Methods: The present study was conducted to evaluate the effect of some selected nutraceuticals in relation to placebo on management of Diabetes Mellitus Type-2. These included Cinnamon (Cinnamomum cassia), Fenugreek (Trigonella foenum-graecum), and Chromium Picolinate. The proximate analysis of Cinnamon & Fenugreek was also done to assess the amount of macronutrients, moisture, ash and fiber content. It was a Randomly Controlled Trial. A sample size of 104 subjects was selected which was equally divided in four intervention groups of 26 each (Cinnamon, Fenugreek, Chromium and Placebo). Biochemical parameters such as Diabetic profile (FPG, Insulin levels, HbA1c), Lipid profile (Cholesterol, Triglycerides, HDL , LDL and VLDL), Hepatic (ALT, ALP), Urinary/Renal profile (microalbumin, total urinary Protein & creatinine) and Blood Complete Picture was studied at three stages i.e. at baseline, three month after intervention and at end of one month washout period. The anthropometric, clinical and dietary data was also collected. The data was analyzed on SPSS 22. Apart from descriptive statistics, data was subjected to repeated measure analysis, and MANOVA to compare all the phases of intervention and inter comparative analysis of three nutraceuticals with placebo. Results: The result outcome was divided and discussed under A, B, C, and D of nutritional status assessment. i.e., Anthropometric, Biochemical, Clinical and Dietary profile of the patients respectively. Out of 104 subjects, 55.8% were males and 44.2% were females. 78% of the subjects were educated having different levels of education; while 22% had no formal education. Majority (63.5%) of the subjects were having sedentary life style. 97% of the subjects shared that they were suffering from some level of stress. Smoking was not common as 64% of the male subjects never smoked, while 87 % of the female population was non- smoker. 74% of the subjects had family history of diabetes, among these 57.70% had close diabetic near relative in the family. vii Majority (89.4%) of the subjects had BMI above normal. None was under weight and only 10.6% were in normal range. Obesity was more prevalent in females as compared to males in all three phases of the study. Intervention of the selected nutraceuticals and change in life style positively affected the mean values of BMI. Central obesity was common feature as 55.8% of the total population was suffering from it. The effect of interventions on anthropometrics was generally positive which was not specifically related to any one of the nutraceuticals as compared to placebo. The statistical analysis proved cinnamon was better in managing different aspects of T2DM with P value of <0.05 as compared to other two nutraceuticals. The descriptive analysis also depicted that the mean marginal difference of cinnamon had better effect on fasting sugar, insulin levels and HbA1c followed by chromium and fenugreek. All the nutraceuticals had some effect on lipid profile (Cholesterol, triglycerides, HDL and LDL) with minor drop towards lower range as compared to placebo. It remained within normal range in all three phases of the study. The Huynh Feldt test was used to measure the significance of “Test of Within Subject Effects” in which the p- value of less than 0.05 which is significant and shows the considerable impact on the dependent variable i.e. diabetic profile. The clinical signs and symptoms and dietary patterns also improved by the end of intervention phase, the impact of which lasted even during the washout period. The estimated marginal means depicted that cinnamon was more prominent in its role followed by chromium and fenugreek with least effect of placebo. The multivariate analysis shows a highly significant difference between ALT levels of all phases (p=0.000). The comparison of different of interventions showed not much difference between them as the p-value was more than 0.050. This shows that although all interventions had some effect on maintaining the ALT and ALP levels of blood towards normal. It was safe to use as no liver toxicity was observed due to intake of any of the nutraceutical for three months.