Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Investigations of the Metabolic Effects of Acute Doses of Palatinit. Comparison with Fructose and Sucrose in Type II Diabetes.

Author:

Bachmann, W., et.al.

Year:

1984

Bibliographic source:

Akt. Ernähr., Vol 6: 65-70

Materials and methods

Endpoint addressed:

acute toxicity: oral

other: metabolic effects

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Acute doses of 50 g test item were given to 8 metabolically healthy volunteers and compared against 50 g fructose or saccharose to 12 each Type II diabetics. Measurements were conducted over a period of 3 hours in respect of capillary blood glucose, serum insulin, free fatty acids in serum, as well as blood lactate and pyruvate. Clinical signs were observed for 12 hours following treatment.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol

EC Number:

908-700-6

Cas Number:

64519-82-0

Molecular formula:

6-O-alpha-D-Glucopyranosyl-D-sorbitol: C12H24O11 1-O-alpha-D-Glucopyranosyl-D-mannitol: C12H24O11

IUPAC Name:

Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol

Method

Ethical approval:

not specified

Details on study design:

The study was conducted on 8 metabolically healthy female volunteers plus 24 type II diabetics. Volunteers and patients were accepted for participation in the study on a volunteer basis only after being informed in detail regarding the procedures of the study. All the diabetics were under treatment with oral antidiabetics (sulfonylurea preparations) and diet. In each case the medication was stopped on the evening before the loading test. he metabolically healthy volunteers received the test item loading only once. The 24 patients were subdivided into two groups of 12 each and received either test item and frutose or test item and sucrose as part of two controlled cross-over studies.

The average age of the volunteers in years was 32.7 ± 4.8, and the body weight according to Broca was 85 ± 12%.

Blood samples were taken of capillary blood to determine the blood glucose, and samples of venous blood were taken through a polyethylene cannula inserted into a cubital vein to determine the serum insulin, serum free fatty acids, blood lactate and blood pyruvate levels. Blood samples were taken after fasting as well as 10, 15, 20, 30, 45, 60, 90, 120,150 and 180 minutes after beginning the oral loading.

Exposure assessment:

not specified

Details on exposure:

TYPE OF EXPOSURE: oral
The loading tests were performed with 50 g test item, 50 g fructose or 50 g sucrose in accordance with the standard conditions of an oral glucose tolerance test. The test items were dissolved in 400 mL water and were to be drunk by the test person within 5 minutes.

Results and discussion

Results:

In metabolically healthy volunteers, neither blood glucose nor serum insulin or lactate showed any significant change in total level over the observation period of 180 min. The same also applies to the free fatty acids and pyruvate. Only the significant curvature in the blood glucose and insulin curves indicated a certain interim, although minimal, loading. One volunteer complained of meteorism and flatulence within the first 12 h after loading, and another also complained of mild diarrhea.

In the two groups with diabetics there were no increases in blood sugar or serum insulin levels after consuming isomalt, in contrast with observations after sucrose or fructose administration. Gastrointestinal symptoms (meteorism, flatulence, and mild diarrhoea) occurred in 2 - 4 persons in each of the 2 groups.