Effects of 12 Weeks consumption of sago starch on glycaemic and lipid control in patients with type 2 diabetes: A double-blind, randomised, parallel controlled trial

INTRODUCTION: Sago starch, rich in type 2 resistant starch, may offer benefits in glucose and lipid regulations in patients with type 2 diabetes. METHODS: We conducted a double-blind, randomised, controlled trial with type 2 diabetes patients, randomised 1:1 into intervention (50g/day sago starch) and control (50g/day corn starch) arms. All participants received standardised diet counselling for diabetes management given at baseline. The primary outcomes were changes in glycaemic endpoints, insulin sensitivity, and lipid levels. Secondary outcomes included changes in calorie intake, body fat, anthropometric, and blood pressure measurements. RESULTS: Of 100 patients enrolled (61 % males; mean [standard deviation or SD] age, 56.8 [8.1] years; mean [SD] haemoglobin A1C, 7.21 % [0.52]), 82 completed the 12-week follow-up and were included in primary analyses. There were no significant between-group change in haemoglobin A1C level (mean difference -0.03 % [95 % confidence interval or CI, -0.24 to 0.19]; p = 0.809), fasting glucose (-0.44 mmol/L [95 % CI, -1.08 to 0.19]; p = 0.170), fasting insulin (-0.31mIU/L [95 % CI, -2.74 to 2.11]; p = 0.797), and Homeostasis Model Assessment for Insulin Resistance (-0.22 [95 % CI, -1.04 to 0.60]; p = 0.590). No significant changes were observed in total cholesterol (0.11 mmol/L [95 % CI, -0.19 to 0.42]; p = 0.472, low-density lipoprotein-cholesterol (0.05 mmol/L [95%CI, -0.24 to 0.35], p = 0.731), high-density lipoprotein-cholesterol (0.13 mmol/L [95%CI, -0.04 to 0.29], p = 0.141), or triglycerides (0.13 mmol/L [95%CI,-0.32 to 0.57], p = 0.574). The intervention group showed a greater reduction in daily calorie intake (-166.1 kcal [95 % CI, -324.4 to -7.8]; p = 0.040) at 12-week; however, this was not statistically significant after correction for multiple comparison. No significant between-group differences were found in other secondary outcomes. CONCLUSION: In this randomised controlled trial, 12-week of sago starch supplementation did not result in significant improvement in glycaemic and lipid parameters in patients with type 2 diabetes. TRIAL REGISTRATIONS: 1. http://nmrr.gov.my - NMRR-21-1905-58409, 2. https://clinicaltrials.gov - NCT05599633.