Clinical trial NCT03806920: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Metabolic Syndrome
Keywords: Isomaltulose
Palatinose
second meal effect
incretin
GIP
GLP-1
postprandial inflammation
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: Beneo GmbH
First posted: 2019-01-16
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: disposition index
timeFrame: 4 visits, separated by 1 week each
measure: insulinogenic index
timeFrame: 4 visits, separated by 1 week each
measure: hepatic insulin extraction
timeFrame: 4 visits, separated by 1 week each
Secondary outcomes:
measure: incretin response
timeFrame: 4 visits, separated by 1 week each
measure: inflammatory reaction
timeFrame: 4 visits, separated by 1 week each
measure: Lipid status
timeFrame: 4 visits, separated by 1 week each
measure: additional endocrine parameters
timeFrame: 4 visits, separated by 1 week each
Other outcomes:
Locations:
city: Potsdam
country: Germany
facility: German Institute of Human Nutrition
state: Brandenburg
Study officials:
References: