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NCT Number: NCT03806920

Isomaltulose VS Sucrose - Postprandial Effect on Incretin Profile and 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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

German Institute of Human Nutrition

Potsdam, Brandenburg, 14458, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention A

Dietary Supplement

Intervention B

Dietary Supplement

Intervention C

Dietary Supplement

Intervention D

Dietary Supplement

Primary outcomes

  1. disposition index

    Time frame: 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)

  2. insulinogenic index

    Time frame: 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).

  3. hepatic insulin extraction

    Time frame: 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).

Secondary outcomes

  1. incretin response

    Time frame: 4 visits, separated by 1 week each

    Parameters: GIP, GLP-1, gastric emptying, Glucagon

  2. inflammatory reaction

    Time frame: 4 visits, separated by 1 week each

    Parameters: IL8, IL-18

  3. Lipid status

    Time frame: 4 visits, separated by 1 week each

    Parameters: NEFA

  4. additional endocrine parameters

    Time frame: 4 visits, separated by 1 week each

    Parameters: FGF21

Sponsors and collaborators

Lead sponsor

German Institute of Human Nutrition

Other

Collaborators

  • Beneo GmbH

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jan 16, 2019
Registry last updated
Jun 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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