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

German Institute of Human Nutrition

Status: Completed

Conditions: Diabetes Mellitus, Type 2; Metabolic Syndrome

Treatments: Dietary Supplement: Intervention A; Dietary Supplement: Intervention B; Dietary Supplement: Intervention C; Dietary Supplement: Intervention D

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03806920

PALA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 4 patient groups

Intervention A

Active Comparator group

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.

Treatment:

Dietary Supplement: Intervention A

Intervention B

Active Comparator group

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.

Treatment:

Dietary Supplement: Intervention B

Intervention C

Active Comparator group

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.

Treatment:

Dietary Supplement: Intervention C

Intervention D

Active Comparator group

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.

Treatment:

Dietary Supplement: Intervention D