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. https://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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