Safety evaluation of a beverage containing mulberry leaf extract

Abstract

Mulberry leaf extract (MLE) has known as inhibits elevated postprandial blood glucose level in human. Then we conducted a randomized, double-blind placebo-controlled parallel-group trial to evaluate safety when a green tea containing MLE is consumed three times a day, every day for four weeks. The participants (n = 48) were randomly allocated into two groups, an MLE beverage group and a control beverage group. The subjects were instructed to drink either a 500 mL green tea containing 550 mg MLE or a 500 mL green tea not containing MLE, three times a day, every day, for four weeks. No adverse reactions were observed over the four weeks trial, and no difference in the incidence of adverse events between the groups. These findings demonstrate that the consumption of a green tea containing 550 mg MLE three times a day for four weeks is safe for healthy adults.

Effect of mulberry leaf or mulberry leaf extract on glycemic traits: a systematic review and meta-analysis

“…The basic characteristics of the 12 studies 36,[45][46][47][48][49][50][51][52][53][54][55] are listed in Table 1. These studies included 326 participants in the intervention group (IG) and 325 participants in the control group (CG), and were published between 2001 and 2022.…”

“…The ages of the participants ranged from 18 to 75 years, and the duration time of the intervention ranged from 4 to 24 weeks. These studies were conducted using healthy, [45][46][47]52,53 T2DM, 36,49,50,54,55 obese, 51 and hyperlipidemic 48 subjects.…”

“…In the RCTs, 7 biases in three studies were estimated as low risk. 49,50,53 Random sequence generation (selection bias) in all studies was considered as low risk. High risk of bias was not assessed in two studies.…”