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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Metabolic Syndrome
• Interventions: Dietary Supplement: Intervention A; Dietary Supplement: Intervention B; Dietary Supplement: Intervention C; Dietary Supplement: Intervention D

• Registration Number: NCT03806920
• Lead Sponsor: German Institute of Human Nutrition

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.

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 Timeline

• Study Start: 2016-11-05
• Study First Submitted: 2017-11-08
• Primary Completion: 2018-09-30
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-16
• Study Completion: 2019-07-30
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-23
• Last Update Posted: 2020-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention A	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.
Intervention B	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.
Intervention C	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.
Intervention D	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.

Primary Outcome Measures

Name	Time	Method
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)
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).
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).

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

German Institute of Human Nutrition; 🇩🇪 Potsdam, Brandenburg, Germany