Efficacy of green jackfruit flour as a medical nutrition therapy replacing rice or wheat in patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study

Background/Objectives: Medical nutrition therapy (MNT) alongside pharmacological interventions is important in treating type 2 diabetes mellitus (T2DM). This study evaluated the efficacy of Jackfruit365 green jackfruit flour as part of daily meals in patients with T2DM. Subjects/Methods: Randomized, double-blind, placebo-controlled trial (May 2019–Feb 2020). Adults aged 18–60 years with T2DM >1 year on oral antihyperglycemic agents were randomized 1:1 to jackfruit flour 30 g/day (Group A) or placebo flour (Group B) added to breakfast and dinner for 12 weeks, replacing an equal volume of rice or wheat flour. Primary endpoint: mean change in HbA1c. Secondary endpoints: changes in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), lipid profile, and body weight. Independent t-test compared changes between groups. Results: Forty patients were enrolled (n=20 per group). Group A had a significantly greater HbA1c reduction vs Group B from baseline to week 12 (−2.73 mmol/mol [−0.25%] vs 0.22 mmol/mol [0.02%], p=0.006). Mean changes in FPG and PPG were significantly greater in Group A (p=0.043 and p=0.001). Continuous glucose monitoring (CGM) showed decreasing mean blood glucose within 7 days of jackfruit flour administration. Conclusion: Jackfruit flour replacement produced significantly greater reductions in HbA1c, FPG, and PPG versus placebo, demonstrating efficacy as MNT when replacing an equal volume of rice or wheat flour in daily meals. Clinical trial registry: CTRI/2019/05/019417.

A. Gopal Rao, K. Sunil Naik, A. G. Unnikrishnan, James Joseph