Abstract

Background/ObjectivesMedical nutrition therapy along with pharmacological interventions as a multidisciplinary approach is required to treat type 2 diabetes mellitus (T2DM). This study evaluated the efficacy of Jackfruit365™ green jackfruit flour as an integral part of daily meal in patients with T2DM.Subjects/MethodsThis was a randomized, double-blind, placebo-controlled study conducted between May 2019 and February 2020. Patients of either sex aged ≥18 to ≤60 years with a diagnosis of T2DM for >1 year receiving oral antihyperglycemic agents were randomized (1:1) to receive either jackfruit flour 30 g/day (Group A) or placebo flour (Group B) (breakfast and dinner) daily for 12 weeks replacing an equal volume of rice or wheat flour. The primary endpoint was a mean change in glycosylated hemoglobin (HbA1c). Other endpoints were mean changes in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), lipid profile, and body weight. The independent t-test was used to compare changes between the groups.ResultsA total of 40 patients were enrolled (n = 20 each). A significantly higher reduction in HbA1c was observed in Group A compared to Group B from baseline to week 12 [−2.73 mmol/mol (−0.25%) vs. 0.22 mmol/mol (0.02%), p = 0.006]. The mean change in FPG and PPG was significantly higher in Group A than that of Group B (p = 0.043 and p = 0.001). The continuous glucose monitoring showed decreasing mean blood glucose in 7 days of administration of jackfruit flour meal.ConclusionPatients from Group A had a significantly higher reduction in HbA1c, FPG, and PPG than Group B demonstrating the efficacy of jackfruit flour in glycemic control as medical nutrition therapy replacing an equal volume of rice or wheat flour in daily meal.Clinical trial registryCTRI/2019/05/019417.

Highlights

  • Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder and if left untreated, leads to uncontrolled hyperglycemia

  • This study aimed to evaluate the efficacy of Jackfruit365TM green jackfruit flour in patients with T2DM

  • A total of 42 patients were enrolled; of which, 2 subjects were excluded as not eligible for the clinical study and 40 patients were randomized into two groups to receive green jackfruit flour (Group A, n = 20) or placebo flour (Group B, n = 20)

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Summary

Introduction

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder and if left untreated, leads to uncontrolled hyperglycemia. There are various approaches available to alleviate and treat diabetes and use of medical nutrition therapy (MNT) is considered an important one. Antidiabetic medication along with MNT plays a synergistic role in the management of blood glucose level. Artocarpus heterophyllus, commonly known as jackfruit, belongs to the mulberry family (Moraceae). It is mostly cultivated in the tropical regions of the world especially in the Western Ghats of India. It is rich in dietary fiber, carbohydrates, vitamins, and minerals. The ripe fruit is very sweet and rich in sugars. There are many concerns surrounding jackfruit consumption by patients with diabetes mainly because of this sweet taste when ripe

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