Blood glucose response after oral intake of lactulose in healthy volunteers: A randomized, controlled, cross-over study

Jasmin Steudle; Christiane Schön; Manfred Wargenau; Lioba Pauly; Susann Schwejda-Güttes; Barbara Gaigg; Angelika Kuchinka-Koch; John F Stover

doi:10.4292/wjgpt.v9.i3.22

Blood glucose response after oral intake of lactulose in healthy volunteers: A randomized, controlled, cross-over study

World J Gastrointest Pharmacol Ther. 2018 Aug 7;9(3):22-30. doi: 10.4292/wjgpt.v9.i3.22.

Authors

Jasmin Steudle¹, Christiane Schön¹, Manfred Wargenau², Lioba Pauly³, Susann Schwejda-Güttes³, Barbara Gaigg⁴, Angelika Kuchinka-Koch⁴, John F Stover⁵

Affiliations

¹ BioTeSys GmbH, Esslingen 73728, Germany.
² M.A.R.C.O. GmbH and Co. KG, Institute for Clinical Research and Statistics, Düsseldorf 40211, Germany.
³ Fresenius Kabi Deutschland GmbH, Oberursel 61440, Germany.
⁴ Fresenius Kabi Austria GmbH, Linz 4020, Austria.
⁵ Fresenius Kabi Deutschland GmbH, Oberursel 61440, Germany. john.stover@fresenius-kabi.com.

Abstract

Aim: To investigate possible changes of blood glucose levels after oral intake of lactulose in healthy subjects.

Methods: The study was performed as prospective, randomized, two-part study with 4-way cross-over design with n = 12 in each study arm. Capillary blood glucose levels were determined over a time period of 180 min after intake of a single dose of 10 g or 20 g lactulose provided as crystal or liquid formulation. During the manufacturing process of lactulose, impurities with sugars (e.g., lactose, fructose, galactose) occur. Water and 20 g glucose were used as control and reference. Because lactulose is used as a functional food ingredient, it may also be consumed by people with impaired glucose tolerance, including diabetics. Therefore, it is of interest to determine whether the described carbohydrate impurities may increase blood glucose levels after ingestion.

Results: The blood glucose concentration-time curves after intake of 10 g lactulose, 20 g lactulose, and water were almost identical. None of the three applications showed any changes in blood glucose levels. After intake of 20 g glucose, blood glucose concentration increased by approximately 3 mmol/L (mean C_max = 8.3 mmol/L), reaching maximum levels after approximately 30 min and returning to baseline within approximately 90 min, which was significantly different to the corresponding 20 g lactulose formulations (P < 0.0001). Comparing the two lactulose formulations, crystals and liquid, in the dosage of 10 g and 20 g, there was no difference in the blood glucose profile and calculated pharmacokinetic parameters despite the different amounts of carbohydrate impurities (1.5% for crystals and 26.45% for liquid). Anyhow, the absolute amount of single sugars was low with 0.3 g in crystals and 5.29 g in liquid formulation in the 20 g dosages. Lactulose was well tolerated by most volunteers, and only some reported mild to moderate mainly gastrointestinal side effects.

Conclusion: The unchanged blood glucose levels after lactulose intake in healthy subjects suggest its safe use in subjects with impaired glucose tolerance.

Keywords: Blood glucose concentration; Functional food ingredient; Lactulose; Sugar substitute.