Healthy AdultsNCT04596709
Investigation of Blood Glucose and Insulin Response After Intake of Vitalose
A study testing Vitalose, isomaltulose and sucrose in people with Healthy Adults, run by Beneo-Institute at 1 site in Germany.
Trial summary
The aim of this study is to assess the postprandial glucose and insulin response of Vitalose. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Vitalose, isomaltulose and sucrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- 22 Oct 2020to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adults
- Age 18-50 years
- BMI ≥18.5 and ≤30.0 kg/m²
Who cannot join
- acute or chronic disease
- food allergy or intolerance
- intake of medications which affect glucose tolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Adults
- Being tested
- Vitalose, isomaltulose, sucrose, glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitaloseDietary supplement
dissolved in water
isomaltuloseDietary supplement
dissolved in water
sucroseDietary supplement
dissolved in water
glucoseDietary supplement
dissolved in water
| Study group | Role | What they receive |
|---|---|---|
| Vitalose | Active comparator | dissolved in water Receives: Dietary Supplement: Vitalose |
| isomaltulose | Active comparator | dissolved in water Receives: Dietary Supplement: isomaltulose |
| sucrose | Placebo comparator | dissolved in water Receives: Dietary Supplement: sucrose |
| glucose | Placebo comparator | dissolved in water Receives: Dietary Supplement: glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
2h iAUC for pp glucose response
Measured: Baseline, 15, 30, 45, 60, 90, 120 minutes
2h iAUC for pp insulin response
Measured: Baseline, 15, 30, 45, 60, 90, 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start22 Oct 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beneo-Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Responsible party
- Sponsor
- Investigators
- Daniel Menzel, Dr., Principal investigator, BioTeSys GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596709
- Sponsor's protocol ID
- BTS1586/20
- Status last verified
- Dec 2020
- First submitted
- 28 Sep 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Blood Glucose and Insulin Response After Intake of Vitalose and Isomaltulose in Comparison to Sucrose and Glucose
- ClinicalTrials.gov ID
- NCT04596709
- Acronym / sponsor ID
- BTS1586/20
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Beneo-InstituteIndustry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the postprandial glucose and insulin response of Vitalose.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitalose | Active comparator | Dietary Supplement: Vitalosedissolved in water |
| isomaltulose | Active comparator | Dietary Supplement: isomaltulosedissolved in water |
| sucrose | Placebo comparator | Dietary Supplement: sucrosedissolved in water |
| glucose | Placebo comparator | Dietary Supplement: glucosedissolved in water |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy adults
- Age 18-50 years
- BMI ≥18.5 and ≤30.0 kg/m²
Key exclusion criteria (3 listed)
- acute or chronic disease
- food allergy or intolerance
- intake of medications which affect glucose tolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitalosedissolved in water | Dietary supplement | Vitalose |
| isomaltulosedissolved in water | Dietary supplement | isomaltulose |
| sucrosedissolved in water | Dietary supplement | sucrose |
| glucosedissolved in water | Dietary supplement | glucose |
Primary outcome
2h iAUC for pp glucose response
Time frame: Baseline, 15, 30, 45, 60, 90, 120 minutes
2h iAUC for pp insulin response
Time frame: Baseline, 15, 30, 45, 60, 90, 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Menzel, Dr. principal investigator
BioTeSys GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitalose, isomaltulose and sucrose in people with Healthy Adults, run by Beneo-Institute at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2h iAUC for pp glucose response (time frame: Baseline, 15, 30, 45, 60, 90, 120 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.