Investigation of Blood Glucose and Insulin Response After Intake of Vitalose

NCT ID: NCT04596709

Last Updated: 2020-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-22

Study Completion Date

2020-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Adults

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitalose

dissolved in water

Group Type ACTIVE_COMPARATOR

Vitalose

Intervention Type DIETARY_SUPPLEMENT

dissolved in water

isomaltulose

dissolved in water

Group Type ACTIVE_COMPARATOR

isomaltulose

Intervention Type DIETARY_SUPPLEMENT

dissolved in water

sucrose

dissolved in water

Group Type PLACEBO_COMPARATOR

sucrose

Intervention Type DIETARY_SUPPLEMENT

dissolved in water

glucose

dissolved in water

Group Type PLACEBO_COMPARATOR

glucose

Intervention Type DIETARY_SUPPLEMENT

dissolved in water

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitalose

dissolved in water

Intervention Type DIETARY_SUPPLEMENT

isomaltulose

dissolved in water

Intervention Type DIETARY_SUPPLEMENT

sucrose

dissolved in water

Intervention Type DIETARY_SUPPLEMENT

glucose

dissolved in water

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

BioTeSys GmbH

OTHER

Sponsor Role collaborator

Beneo-Institute

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel Menzel, Dr.

Role: PRINCIPAL_INVESTIGATOR

BioTeSys GmbH

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

BioTeSys GmbH

Esslingen am Neckar, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BTS1586/20

Identifier Type: -

Identifier Source: org_study_id