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

Primary Purpose

Diabetes Mellitus, Type 2, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Intervention A
Intervention B
Intervention C
Intervention D
Sponsored by
German Institute of Human Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring Isomaltulose, Palatinose, second meal effect, incretin, GIP, GLP-1, postprandial inflammation

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • German Institute of Human Nutrition

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Intervention A

Intervention B

Intervention C

Intervention D

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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)
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).
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).

Secondary Outcome Measures

incretin response
Parameters: GIP, GLP-1, gastric emptying, Glucagon
inflammatory reaction
Parameters: IL8, IL-18
Lipid status
Parameters: NEFA
additional endocrine parameters
Parameters: FGF21

Full Information

First Posted
November 8, 2017
Last Updated
June 23, 2020
Sponsor
German Institute of Human Nutrition
Collaborators
Beneo GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03806920
Brief Title
Isomaltulose VS Sucrose - Postprandial Effect on Incretin Profile and Second Meal Effect
Official Title
Isomaltulose VS Sucrose - Different Postprandial Effect on Incretin Profile and Determinants of the Second Meal Effect
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 5, 2016 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
German Institute of Human Nutrition
Collaborators
Beneo GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Metabolic Syndrome
Keywords
Isomaltulose, Palatinose, second meal effect, incretin, GIP, GLP-1, postprandial inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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 T2DM
Masking
Participant
Masking Description
participants were unaware of selected sugar intake prior to second meal
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention B
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention C
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention D
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention A
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention B
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention C
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention D
Primary Outcome Measure Information:
Title
disposition index
Description
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)
Time Frame
4 visits, separated by 1 week each
Title
insulinogenic index
Description
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).
Time Frame
4 visits, separated by 1 week each
Title
hepatic insulin extraction
Description
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).
Time Frame
4 visits, separated by 1 week each
Secondary Outcome Measure Information:
Title
incretin response
Description
Parameters: GIP, GLP-1, gastric emptying, Glucagon
Time Frame
4 visits, separated by 1 week each
Title
inflammatory reaction
Description
Parameters: IL8, IL-18
Time Frame
4 visits, separated by 1 week each
Title
Lipid status
Description
Parameters: NEFA
Time Frame
4 visits, separated by 1 week each
Title
additional endocrine parameters
Description
Parameters: FGF21
Time Frame
4 visits, separated by 1 week each

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
German Institute of Human Nutrition
City
Potsdam
State/Province
Brandenburg
ZIP/Postal Code
14458
Country
Germany

12. IPD Sharing Statement

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

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