NCT04596709

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 22, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 7, 2020

Status Verified

December 1, 2020

Enrollment Period

1 month

First QC Date

September 28, 2020

Last Update Submit

December 3, 2020

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

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

VitaloseDIETARY_SUPPLEMENT

dissolved in water

Vitalose
isomaltuloseDIETARY_SUPPLEMENT

dissolved in water

isomaltulose
sucroseDIETARY_SUPPLEMENT

dissolved in water

sucrose
glucoseDIETARY_SUPPLEMENT

dissolved in water

glucose

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BioTeSys GmbH

Esslingen am Neckar, Germany

Location

MeSH Terms

Interventions

isomaltuloseSucroseGlucose

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsHexosesMonosaccharides

Study Officials

  • Daniel Menzel, Dr.

    BioTeSys GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 22, 2020

Study Start

October 22, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

December 7, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)