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

NCT03806920 | Completed

• 1 other identifier: PALA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Metabolic Syndrome

Keywords

Isomaltulose; Palatinose; second meal effect; incretin; GIP; GLP-1; postprandial inflammation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• incretin response

  4 visits, separated by 1 week each

• inflammatory reaction

  4 visits, separated by 1 week each

• Lipid status

  4 visits, separated by 1 week each

• additional endocrine parameters

  4 visits, separated by 1 week each

Study Arms (4)

Intervention A

ACTIVE COMPARATOR

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

Intervention B

ACTIVE COMPARATOR

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

Intervention C

ACTIVE COMPARATOR

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

Intervention D

ACTIVE COMPARATOR

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

Interventions

Intervention A DIETARY_SUPPLEMENT

Intervention A

Intervention B DIETARY_SUPPLEMENT

Intervention B

Intervention C DIETARY_SUPPLEMENT

Intervention C

Intervention D DIETARY_SUPPLEMENT

Intervention D

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• medications: intake of medications which influence glucose metabolism
• alcohol / drug abuse
• physical diseases: endocrinological, malign, serious cardiovascular diseases
• acute / chronic communicable disease
• psychic diseases

Sponsors & Collaborators

• German Institute of Human Nutrition: lead
• Beneo GmbH: collaborator

Study Sites (1)

German Institute of Human Nutrition

Potsdam, Brandenburg, 14458, Germany

Location

Related Publications (1)

• Zhang J, Schafer SM, Kabisch S, Csanalosi M, Schuppelius B, Kemper M, Markova M, Meyer NMT, Pivovarova-Ramich O, Keyhani-Nejad F, Rohn S, Pfeiffer AFH. Implication of sugar, protein and incretins in excessive glucagon secretion in type 2 diabetes after mixed meals. Clin Nutr. 2023 Apr;42(4):467-476. doi: 10.1016/j.clnu.2023.02.011. Epub 2023 Feb 21.

  PMID: 36857956 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants were unaware of selected sugar intake prior to second meal
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director (Dpt. Clinical Nutrition)

Model Details: 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

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: January 16, 2019
• Study Start: November 5, 2016
• Primary Completion: September 30, 2018
• Study Completion: July 30, 2019
• Last Updated: June 24, 2020

Record last verified: 2020-06

Locations

DE (1)