Comparison of High Carbohydrate, Whole Food Plant- Based Diet to Standard Mixed Diabetic Diet in the Management of Type 2 Diabetes Mellitus in a Tertiary Care Hospital: A Randomised Controlled Trial

Abstract

INTRODUCTION: Type 2 diabetes mellitus (T2DM) is a major public health concern. According to the International Diabetes Federation (IDF) as of 2021 there are 537 million adults living with diabetes. T2DM is by far the most common type of diabetes mellitus in adults (>90%). Diabetes mellitus is caused by varying degrees of insulin resistance and defective insulin secretion (beta cell dysfunction) or both. The etiopathogenesis for diabetes is multifactorial and includes genetic predisposition, environment factors, fetal programming, epigenetics and inflammation. Diabetes mellitus is diagnosed in those with a HbA1C of ≥6.5%, fasting plasma glucose ≥ 126mg/dl or a 2-hour plasma glucose of ≥ 200mg/dl. As per the American Diabetic Association (ADA) guidelines, diabetes mellitus should be screened for all adults ≥ 35 years, or even earlier for those with obesity, hypertension. strong family history, dyslipidemia, polycystic ovarian syndrome, past history of gestational diabetes mellitus or other conditions associated with insulin resistance (e.g., acanthosis nigricans). The goals of treatment are to control blood sugars, prevent microvascular and macrovascular complications as well as to ensure a good quality of life. The treatment of diabetes is centered around the patient. AIM OF THE STUDY: The aim of the study is to compare the efficacy of two different types of diabetic diets [a high-carbohydrate (70-75% of the total calorie intake), whole food, plant-based diet and a moderate carbohydrate (50-60% of the total calorie intake) standard, mixed diabetic diet] for their efficacy in improving glycaemic control by lowering of HbA1c levels. OBJECTIVES: Diabetes Mellitus is a disease with a large global burden. Current treatment strategies include medical nutrition therapy, physical activity, oral antidiabetic agents and insulin. At present there is a paradigm shift towards a more holistic approach in diabetic management. We investigated whether there is a difference in the glycaemic control among type 2 diabetics allocated to a high carbohydrate, whole food plant-based diet in comparison to a standard diabetic diet. METHODS: We did a single-center, open-label, assessor blinded, randomised controlled trial to compare the efficacy of two different types of diabetic diets in lowering HbA1c levels. After obtaining informed consent, we randomly allocated 94 participants with type 2 diabetes mellitus to receive either a high carbohydrate, whole food plant-based diet (carbohydrate 70-75%) or a moderate carbohydrate, standard diabetic diet (carbohydrate 50-60%). Participants were followed up for a total of 3 months. At enrollment they were given an intensive dietary education by a certified dietician and were instructed in maintaining a food dairy. During the study period they received weekly telephone calls to ensure compliance, tackle any practical difficulties, motivate participants and ensure they fill the 24-hour food diary. After the completion of 3 months, they underwent repeat testing of the baseline parameters (anthropometry, blood glucose, HbA1c, fasting lipids and a Montreal cognitive questionnaire) to check for difference. RESULTS: Of the total of 50 participants who under randomization, 47 completed the study. The median decrease in HbA1c was -0.2% (-0.5 — 0.2) and -0.2% (-0.9 — 0.2) in the standard diabetic diet and the whole food plant-based diet respectively. Both diets also showed a trend towards a reduction in the body weight and fasting lipid profile. There was no difference between the diets in any of the outcomes assessed. There were no major adverse events noted in our study. CONCLUSION: In patients with type 2 diabetes mellitus, both the standard diabetic diet and the whole food plant-based diets are dietary options that can be advised