Isomaltulose VS Sucrose - Postprandial Effect on Incretin Profile and Second Meal Effect

Sponsor

German Institute of Human Nutrition (Other)

Overall Status

Completed

CT.gov ID

NCT03806920

Collaborator

Beneo GmbH (Industry)

Enrollment

Location

Arms

32.8

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the different postprandial effect of isomaltulose and sucrose on the incretin profile and as an determinant for the second meal effect.

In this nutritional intervention study, healthy participants and T2DM patients ingest 2 standardized meals for breakfast and lunch in combination with either sucrose or palatinose on 2 separate days. In addition, blood samples are taken to analyze markers of the carbohydrate metabolism, incretins and specific inflammation markers.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Metabolic Syndrome	Dietary Supplement: Intervention A Dietary Supplement: Intervention B Dietary Supplement: Intervention C Dietary Supplement: Intervention D	N/A

Detailed Description

Isomaltulose is a natural occurring disaccharide with a similar structure to sucrose. It is composed of glucose and fructose, but is linked by an α-1,6-glycosidic bond instead of α-1,2. Due to its binding, isomaltulose is slowly hydrolysed, which results in a rather weak postprandial glycemic-insulinemic response, accompanied by a minimal GIP secretion and a stimulated secretion of GLP-1. In addition, several studies have shown that the intake of foods with a low glycemic index, such as isomaltulose, tend to improve the metabolic reaction to a subsequent meal. As the exact mechanism of this "second meal effect" is still unknown, the investigators hypothesize that the modified release and action of GIP and GLP-1 are key players in regard to the described effects.Therefore, isomaltulose could be a suitable tool for reducing the risk of developing diabetes, obesity and CVD as well as improve blood glucose control in people with diabetes.

In summary, this study evaluates the different postprandial effect of isomaltulose and sucrose on the incretin profile and as a determinant for the second meal effect.

In this nutritional intervention study, healthy participants and T2DM patients ingest 2 standardized meals for breakfast and lunch in combination with either sucrose or palatinose on 2 separated days. In addition, blood samples are taken to analyze markers of the carbohydrate metabolism, incretins and specific inflammation markers.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Comparison of sucrose vs. palatinose (isomaltulose) on second meal effect (high-GI meal vs. high-protein meal) in subjects with T2DM or metabolic Syndrome without T2DMComparison of sucrose vs. palatinose (isomaltulose) on second meal effect (high-GI meal vs. high-protein meal) in subjects with T2DM or metabolic Syndrome without T2DM

Masking:

Single (Participant)

Masking Description:

participants were unaware of selected sugar intake prior to second meal

Primary Purpose:

Prevention

Official Title:

Isomaltulose VS Sucrose - Different Postprandial Effect on Incretin Profile and Determinants of the Second Meal Effect

Actual Study Start Date :

Nov 5, 2016

Actual Primary Completion Date :

Sep 30, 2018

Actual Study Completion Date :

Jul 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention A Nutritional intervention in healthy subjects and T2DM subjects: Accompanying a carbohydrate based breakfast, participants ingest either 50 g sucrose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours.	Dietary Supplement: Intervention A
Active Comparator: Intervention B Nutritional intervention in healthy subjects and T2DM subjects: Accompanying a carbohydrate based breakfast, participants ingest either 50 g palatinose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours.	Dietary Supplement: Intervention B
Active Comparator: Intervention C Nutritional intervention in healthy subjects: Accompanying a protein-based breakfast, participants ingest either 50 g sucrose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours.	Dietary Supplement: Intervention C
Active Comparator: Intervention D Nutritional intervention in healthy subjects: Accompanying a protein-based breakfast, participants ingest either 50 g isomaltulose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours.	Dietary Supplement: Intervention D

Outcome Measures

Primary Outcome Measures

disposition index [4 visits, separated by 1 week each]
Alteration of the Insulin secretion due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved beta-cell response (Insulin secretion)
insulinogenic index [4 visits, separated by 1 week each]
Alteration of the incretin profile due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved second meal effect (Insulin sensitivity).
hepatic insulin extraction [4 visits, separated by 1 week each]
Alteration of the incretin profile due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved hepatic insulin extraction (secondary effect of improved Insulin sensitivity).

Secondary Outcome Measures

incretin response [4 visits, separated by 1 week each]
Parameters: GIP, GLP-1, gastric emptying, Glucagon
inflammatory reaction [4 visits, separated by 1 week each]
Parameters: IL8, IL-18
Lipid status [4 visits, separated by 1 week each]
Parameters: NEFA
additional endocrine parameters [4 visits, separated by 1 week each]
Parameters: FGF21