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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03806920
• Other study ID #: PALA
• Status: Completed
• Phase: N/A
• Start date: November 5, 2016
• Est. completion date: July 30, 2019

Study information

• Verified date: June 2020
• Source: German Institute of Human Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 30, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• for T2DM patients: insulin-independent

• for healthy subjects: at least 1 component of the metabolic syndrom:

• Body mass index (BMI) = 30 kg/m²

• Waist-hip ratio (WHR) = 85 for women and = 90 for men

• hypertension

• dyslipidemia

• glucose / insulin intolerance

Exclusion Criteria:

• medications: intake of medications which influence glucose metabolism

• alcohol / drug abuse

• physical diseases: endocrinological, malign, serious cardiovascular diseases

• acute / chronic communicable disease

• psychic diseases

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Metabolic Syndrome

Intervention

Dietary Supplement:
• Intervention A

• Intervention B

• Intervention C

• Intervention D

Locations

Country	Name	City	State
Germany	German Institute of Human Nutrition	Potsdam	Brandenburg

Sponsors (2)

Lead Sponsor	Collaborator
German Institute of Human Nutrition	Beneo GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disposition index	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)	4 visits, separated by 1 week each
Primary	insulinogenic index	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).	4 visits, separated by 1 week each
Primary	hepatic insulin extraction	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).	4 visits, separated by 1 week each
Secondary	incretin response	Parameters: GIP, GLP-1, gastric emptying, Glucagon	4 visits, separated by 1 week each
Secondary	inflammatory reaction	Parameters: IL8, IL-18	4 visits, separated by 1 week each
Secondary	Lipid status	Parameters: NEFA	4 visits, separated by 1 week each
Secondary	additional endocrine parameters	Parameters: FGF21	4 visits, separated by 1 week each