Investigation of Blood Glucose and Insulin Response After Intake of Vitalose

Investigation of Blood Glucose and Insulin Response After Intake of Vitalose and Isomaltulose in Comparison to Sucrose and Glucose

The aim of this study is to assess the postprandial glucose and insulin response of Vitalose.

Study Overview

• Status: Completed
• Conditions: Healthy Adults
• Intervention / Treatment: Dietary supplement: Vitalose; Dietary supplement: isomaltulose; Dietary supplement: sucrose; Dietary supplement: glucose

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Esslingen, Germany
    • BioTeSys GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy adults
• Age 18-50 years
• BMI ≥18.5 and ≤30.0 kg/m²

Exclusion Criteria:

• acute or chronic disease
• food allergy or intolerance
• intake of medications which affect glucose tolerance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vitalose; dissolved in water	Dietary supplement: Vitalose; dissolved in water
Active Comparator: isomaltulose; dissolved in water	Dietary supplement: isomaltulose; dissolved in water
Placebo Comparator: sucrose; dissolved in water	Dietary supplement: sucrose; dissolved in water
Placebo Comparator: glucose; dissolved in water	Dietary supplement: glucose; dissolved in water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
2h iAUC for pp glucose response	Baseline, 15, 30, 45, 60, 90, 120 minutes
2h iAUC for pp insulin response	Baseline, 15, 30, 45, 60, 90, 120 minutes

Collaborators and Investigators

• Sponsor: Beneo-Institute
• Collaborators: BioTeSys GmbH
• Investigators: Principal Investigator: Daniel Menzel, Dr., BioTeSys GmbH

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2020
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 7, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BTS1586/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No