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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Intervention A; Dietary supplement: Intervention B; Dietary supplement: Intervention C; Dietary supplement: Intervention D

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Brandenburg
    • Potsdam, Brandenburg, Germany, 14458
      • German Institute of Human Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: German Institute of Human Nutrition
• Collaborators: Beneo GmbH

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2016
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): July 30, 2019

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: GLP-1; incretin; GIP; second meal effect; Isomaltulose; Palatinose; postprandial inflammation
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Insulin Resistance; Hyperinsulinism; Diabetes Mellitus, Type 2; Metabolic Syndrome
• Other Study ID Numbers: PALA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No