Antihyperglycemic effect of short-term arginyl-fructose supplementation in subjects with prediabetes and newly diagnosed type 2 diabetes: randomized, double-blinded, placebo-controlled trial

BACKGROUND: A previous study reported that arginyl-fructose may have great value as a functional food with antioxidant and antidiabetic activities. However, there have been few clinical studies on the efficacy of arginyl-fructose supplementation for blood glucose control. METHODS: In this double-blind, placebo-controlled study, 60 Korean subjects with prediabetes or type 2 diabetes mellitus were randomly assigned to placebo or test groups. The test group subjects received 1500 mg/day arginyl-fructose. Fasting serum levels of glucose, hemoglobin A1c, insulin, and free fatty acids were measured by 2-hour oral glucose tolerance tests at baseline and after the 6-week intervention. Eleven subjects dropped out or were excluded during the trial. The data for the remaining 49 were statistically analyzed using Student’s t-test and paired t-test. RESULTS: After the 6-week intervention, the test group showed significant reductions in serum glucose levels at 30 minutes (−19.4 ± 5.62 mg/dL) and 60 minutes (−15.4 ± 7.01 mg/dL) and reduced glucose area under the curve (−27.4 ± 8.59 mg/dL) compared with those of the placebo control group. The changes (differences from baseline) in serum glucose levels at 60 minutes and glucose area under the curve in the test group differed significantly from those in the control group even after adjusting for baseline values. In contrast, glucose-related biomarkers including hemoglobin A1c, insulin, and C-peptide levels were not significantly improved by the dietary intervention with arginyl-fructose. CONCLUSIONS: Arginyl-fructose supplementation (1500 mg/day) may be beneficial for reducing postprandial blood glucose levels in patients with prediabetes or type 2 diabetes mellitus. TRIAL REGISTRATION: ClinicalTrials.gov NCT02285231. Registered 11 May 2014. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-1036-z) contains supplementary material, which is available to authorized users.