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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2, Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Intervention A
* Dietary Supplement: Intervention B
* Dietary Supplement: Intervention C
* Dietary Supplement: Intervention D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention A<br>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<br> <br> |
| Active Comparator: Intervention B<br>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<br> <br> |
| Active Comparator: Intervention C<br>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<br> <br> |
| Active Comparator: Intervention D<br>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<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GIP, Isomaltulose, Palatinose, second meal effect, incretin, GLP-1, postprandial inflammation