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

Endocrinol Diabetes Nutr. 2019. //doi.org/10.1016/j.endinu.2018.12.008

Mohsenpour MA, Kaseb F, Nazemian R, et al.

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Objective

  • To examine 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.

Background

  • Various compounds such as sugars, sugar alcohols and non-sugar compounds (stevia, xylitol, and aspartame) have been introduced to induce the sweet taste in food industry.
  • Lacritose, a new sweetener, was recently introduced by mixing the following four sugars: lactose, fructose, sucrose, and erythritol.
  • Although previous studies have shown sugars can interact each other during absorption in the intestine and slowdown or increase each other’s absorption, further research is needed regarding the glycemic response and possible gastrointestinal adverse reactions associated with Lacritose.

Methods

  • Forty participants, including 20 diabetic patients and 20 healthy individuals, ages 20-60 (mean age = 40) were enrolled between February and October of2016.
  • A double-blind, three way randomized cross-over clinical trial was conducted in which each participant served as his/her own control. After fasting overnight for at least 10 hours, participants were randomly given 300ml servings of three beverages containing 50g glucose, sucrose and lacritose. Blood samples were collected before and afterwards every 30 minutes for up to 2 hours. 
  • Demographic data was collected and anthropometric assessments were conducted on each intervention day.  A gastrointestinal reaction questionnaire, which assessed pain in the stomach and abdomen, heartburn, reflux, appetite, etc., was completed for each participant one day after the intervention day by a trained nutritionist on the phone.

Findings

  • Mean blood glucose was significantly lower during consumptions of lacritose compared to sucrose and glucose (mean± standard error (SE) for lacritose: 114.9 ± 2.5, glucose:154.8 ± 5.0, sucrose: 134.3 ± 4.0, P-value <0.001).  Also the increasing of blood glucose at different times was significantly different between the three drinks.
  • In both participants with diabetes mellitus and healthy subjects, blood glucose was significantly lower after ingesting lacritose when compared to other beverages, after adjustment for BMI, gender, age and rolling method (P-value <0.05).
  • The number of participants reporting abdominal pain, epigastric pain and also nausea after ingestion of the test beverages were higher when they ingested lacritose.  However the difference between beverages were not statistically significant for abdominal pain (P-value = 0.165), epigastric pain (P-value = 0.097) and nausea (P-value = 0.717).

Conclusions

  • Blood glucose levels were significantly lower after ingestion of one 50 g dose of lacritose, as compared to identical servings of glucose and sucrose.
  • Although lacritose contains lactose, the gastrointestinal adverse reactions after its ingestion was not significantly different compared to glucose and sucrose.
  • Further studies with more study participants examining the long-term effects of lacritose on appetite, body weight and other metabolic markers of long-term glucose control are recommended.

Points to Consider

  • The present study included a sample of only 40 participants and did not assess the effect of lacritose on appetite, insulin response and long-term outcomes.
  • The long-term effect of lacritose on overall health are unknown and given its relatively high amount of lactose and erythritol, they may be adverse reactions associated with long-term use.  
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