Safety and efficacy of a 48-week long-term ingestion of D-allulose in subjects with high LDL cholesterol levels

Abstract

D-allulose is one of the rare sugars with almost zero calories and several health ben- ef its. Previous studies have reported the safety of D-allulose in normal, overweight/obese, and diabetic humans. However, one study reported signif icant increases in T-Cho and LDL-C after 12 weeks of D-al- lulose intake; this report was not a randomized controlled trial and these changes were considered to be due to seasonal variations. We, therefore, conducted a randomized, double-blind, placebo-controlled trial in 90 subjects with high LDL-C levels for 48 weeks to clarify the inf luence of long-term D-allulose con- sumption on cholesterol metabolism and eff icacy. Subjects were randomly divided into 3 groups: high- dose D-allulose (15 g D-allulose/day), low-dose D-allulose (5 g D-allulose/day), and placebo group (0 g D-allulose/day); each subject consumed a daily test beverage for 48 weeks. Clinical examinations were performed every eight weeks, beginning from initial consumption until week 52. No signif icant increas- es in T-Cho and LDL-C between test groups were observed, and 48 weeks of D-allulose consumption did not change risk factors for atherosclerotic cardiovascular disease. Furthermore, no clinical problems were recognized for other parameters. Additionally, signif icant improvements in hepatic enzyme activities, fat- ty liver score, and glucose metabolism after long-term D-allulose consumption were observed. The results from our study revealed that 1) D-allulose consumption is considered safe for long-term intake up to a year, and 2) D-allulose may be effective for improving hepatic functions and glucose metabolism. Key