Investigation of Blood Glucose and Insulin Response After... | NCT04596709

Studies
Investigation of Blood Glucose and Insulin Response After Intake of Vitalose

NCT04596709

Sponsor

Beneo-Institute

Status

Completed

Last Update Posted

Dec 7, 2020Actual

Enrollment

13Actual

Phase

Not Applicable

Conditions

Healthy Adults

Interventions

Vitalose
isomaltulose
sucrose
glucose

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 22, 2020Actual

Primary Completion Date

Dec 1, 2020Actual

Completion Date

Dec 1, 2020Actual

First Submitted Date

Sep 28, 2020

First Submission Date that Met QC Criteria

Oct 20, 2020

First Posted Date

Oct 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2020

Last Update Posted Date

Dec 7, 2020Actual

Name	Class
BioTeSys GmbH	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitalose	Active Comparator	dissolved in water	Dietary Supplement: Vitalose
isomaltulose	Active Comparator	dissolved in water	Dietary Supplement: isomaltulose
sucrose	Placebo Comparator	dissolved in water	Dietary Supplement: sucrose
glucose	Placebo Comparator	dissolved in water	Dietary Supplement: glucose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitalose	Dietary Supplement	dissolved in water	Vitalose
isomaltulose

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Menzel, Dr.	BioTeSys GmbH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BioTeSys GmbH		Esslingen am Neckar			Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C008189	isomaltulose
D013395	Sucrose
D005947	Glucose

Ancestor Terms

ID	Term
D004187	Disaccharides
D009844	Oligosaccharides
D011134	Polysaccharides
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided