A Complementary Therapy with Whey Protein in Diabetes: A Double-Blind Randomized Controlled Clinical Trial

Abstract

Type 2 diabetes (T2DM) and its complications can cause severe morbidity and mortality. The researchers and clinicians’ attention has been toward finding the efficient treatment for T2DM to decrease its heavy burden on the people and countries. Whey protein (WP) is a known glucose-lowering treatment of traditional Persian medicine. This randomized controlled clinical trial aimed to evaluate the efficacy of the WP on the improvement of the glycemic index of the patients with T2DM in Fars, Fasa, Iran. A total of 58 people with T2DM met the inclusion criteria and were randomly assigned to one of two groups: intervention or placebo. For 12 weeks, they were given 1 sachet of WP or 1 sachet of placebo. Before and after the trial, fasting blood sugar, lipid profile, and liver enzymes were tested. Finally, 35 patients completed the study (18 in the whey group and 17 in the placebo group). The mean ± standard deviation of age, BMI, and the disease duration in placebo group were: 52.1±9.2 years, 26.8±3.9 kg/m² and 102.9±67.7 months and in WP group were 51.2±8.2 years, 25.7±3.7 kg/m2 and 74.2±51.1 months. There were no significant differences among the study groups at the beginning (P>0.05). Meanwhile, the WP and placebo groups were the same by means of the amount of anti-diabetic drugs that participants consumed (P=0.242). After 12 weeks: the fasting blood sugar (FBS) and hemoglobin A1C amounts showed important decreases in the WP group compared to its starting point (P=0.011 and P=0.001 respectively), while in the placebo group, there was no significant difference in this matter (P>0.05).  No severe complications were reported in both groups. In conclusion, we found that whey protein would be a promising complementary therapy to control hyperglycemia in the patients with T2DM.