The effect of a new mixture of sugar and sugar-alcohols compared to sucrose and glucose on blood glucose increase and the possible adverse reactions: A phase I double-blind, three-way randomized cross-over clinical trial

Abstract

Introduction: Several sweeteners are introduced to replace sucrose in the human diet. However, they had their own limitations and concerns, particularly in terms of their taste and their long-term health consequences. This study examined the effect of a new mixture of sugars and sugar alcohol on the postprandial blood glucose levels and its possible gastrointestinal (GI) adverse reactions in human adults.

Methods: In this double-blind three-way randomized clinical trial, adults (21 with type 2 diabetes and 20 healthy) received 300ml of three beverages containing 50g glucose, sucrose, and lacritose (a mixture of lactose, fructose, sucrose, and erythritol) when they were in the fasted state in a random order. Postprandial serum glucose was checked every 30min up to 2h and the gastrointestinal reactions were collected.

Results: The mean serum glucose was significantly lower in all time points after ingestion of the lacritose for participants with type 2 diabetes compared to glucose and sucrose (P<0.05). The blood glucose levels were significantly lower in the 30th and 60th min for healthy subjects (P<0.05). Adverse GI reactions were not significant between the test beverages.

Conclusions: The ingestion of a 50g dose of lacritose containing lactose, fructose, sucrose, and erythritol, led to an improved blood glucose levels without any significant adverse effect compared to the same amount of glucose and sucrose. Studying the long-term effects of lacritose on appetite, metabolic markers and adverse reactions is recommended. The trial was registered in Iranian registry of clinical trials: IRCT2015050912571N2.

Keywords: Alcoholes de azúcar; Azúcares; Blood glucose control; Control de la glucemia; Diabetes; Edulcorante; Sugar alcohols; Sugars; Sweetener.