Sugar; Blood, LowPhase 1NCT05457400
ENSO 16 - Study in Healthy Subjects
A Phase 1 study testing ENSO 16 and Glucose Powder in people with Sugar; Blood, Low, run by Alpha Republic GmbH at 1 site in Austria.
Trial summary
The objective of this study is to evaluate differences in glucose metabolism parameters after oral administration of 30g glucose or 30g ENSO16. Blood samples will be be collected from 15 male or female subjects at defined time points (0 - 15 - 30 - 45 - 60 - 90 - 120 180 minutes; 3 min at each time point). Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Sugar; Blood, Low
- What is being tested?
- ENSO 16 and Glucose Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteAustria
- Study dates
- 28 Apr 2022to 29 Jul 2022
- Phase
- Phase 1
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability of subject to understand the character and individual consequences of the study;
- Signed informed consent before the start of any specific study procedures;
- Age ≥18 years;
- BMI 18-25 and healthy
- Fasting blood glucose ≤ 100mg/dL (point of care device)
Who cannot join
- Substance or alcohol abuse
- Smoking
- Regular intake of medication (except oral contraceptives) including over the counter drugs within 2 weeks before study day 1
- Chronic medical illness
- Food allergies and dietary restrictions
- Pregnancy
- Participation in another clinical trial 3 weeks before study day 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Active-controlled, Cross-over Study to Assess the Effect of the Sugar Substitute "ENSO 16" on Glucose Metabolism Parameters in Healthy Subjects
The objective of this study is to evaluate differences in glucose metabolism parameters after oral administration of 30g glucose or 30g ENSO16. Blood samples will be be collected from 15 male or female subjects at defined time points (0 - 15 - 30 - 45 - 60 - 90 - 120
- 180 minutes; 3 min at each time point). Individual plasma glucose, insulin and C-peptide concentrations are going to be evaluated and statistically assessed. Subjects will also be asked to complete a questionnaire regarding their digestion after oral intake of ENSO 16 or glucose defined timepoints.
Read the detailed description
This is a randomized, double-blind, active-controlled, cross-over study to assess the effect of the sugar substitute "ENSO 16" on glucose metabolism parameters in healthy male or female subjects. 15 healthy subects ≥ 18 years will be included and 30 g of ENSO 16 or 30 g glucose will be orally administered to assess the impact on markers of glucose metabolism. The study medication will be dissolved in 200 mL tap water. After randomization, subjects will receive ENSO 16 (group A) or glucose (group B) on the first study day. Following a wash-out period of at least on week, subjects will receive glucose (group A) or ENSO 16 (group B) on the second study day. A screening examination (inclusion/ exclusion criteria, medical history, etc.) will be done on the first study day before the study medication will be administered. The study medication will be administered after an overnight fast of at least 10h. Subjects will receive a venular cannula and blood is going to be collected at 8 pre-defined timepoints (0 - 15 - 30 - 45 - 60 - 90 - 120 - 180 minutes; 3 min at each time point). In total, 192 mL of blood are going to be collected per study participant. Study participants will also have to fill in a questionnaire to rate gastrointestinal symptoms using a checklist including the following questions: ((a) abdominal pain, (b) nausea, (c) vomiting, (d) diarrhoea, (e) abdominal rumbling, (f) bloating, (g) belching and (h) flatulence. Participants were asked to choose between "no symptom" (0 points), "mild symptoms" (1 point) and "severe symptoms" (2 points) for each question at each time point.
Primary Endpoint To test the effect of orally administered ENSO 16 (30 g) or glucose (30 g) on plasma glucose levels. The area under the curve (AUC) of plasma glucose profiles (0-60 min) will be compared between different study days.
Null and alternative hypotheses:
H0: There is no difference in blood glucose AUC (0-60 min) between glucose and ENSO 16. H1: There is a difference in blood glucose AUC (0-60 min) between glucose and ENSO 16. Sample size calculation No formal sample size calculation could be performed for this trial as ENSO 16 has never been tested on glucose metabolism parameters in a clinical trial. There is evidence that sugar substitutes have to be studied separately because sweeteners differ considerably in their chemical structure and their physiologic effect on glucose metabolism. However, based on a cross-over trial with the sugar substitute xylitol at high doses, a sample size of 12 was appropriate to detect significant differences in outcome parameters. Based on these study results and on available statistical recommendations, a sample size of 15 was chosen, which is considered to be appropriate for this cross over trial to detect significant differences in the main outcome parameters if present. Statistical methodology Calculation of the AUC (0-60 min) for plasma glucose, insulin and Cpeptide profiles. Paired T-tests or Wilcoxon signed rank tests (for skewed distributions) will be applied to describe differences between treatments (glucose and ENSO 16)
- Conditions
- Sugar; Blood, Low
- Being tested
- ENSO 16, Glucose Powder
- Keywords
- Sugar Substitutes, Fibers, Blood Glucose Rise, Blood Glucose Level, Polyols, Blood Glucose Spike
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENSO 16Drug
30 g ENSO 16 dissolved in Water
Glucose PowderDrug
30 g Glucose Powder dissolved in Water
| Study group | Role | What they receive |
|---|---|---|
| ENSO 16 | Active comparator | The participants receive 30g ENSO 16 dissolved in 200 mL water and blood will be collected at defined time points (0 - 15 - 30 - 45 - 60 - 90 - 120 - 180 minutes; ±3 min at each time point). Receives: Drug: ENSO 16 |
| Glucose Powder | Active comparator | The participants receive Glucose in the same dosage and blood is also taken at the same time points. Receives: Drug: Glucose Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on blood sugar
To test the effect of orally administered ENSO 16 (30 g) or glucose (30 g) on plasma glucose levels. The area under the curve (AUC) of plasma glucose profiles (0-60 min) will be compared between different study days.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start28 Apr 2022
- Primary completion14 Jun 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sugar; Blood, LowStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The objective of this study is to evaluate differences in glucose metabolism parameters after oral administration of 30g glucose or 30g ENSO16. Blood samples will be be collected from 15 male or female subjects at defined time points (0 - 15 - 30 - 45 - 60 - 90 - 120 \- 180 minutes; 3 min at each time point). Individual plasma glucose, insulin and C-peptide concentrations are going to be evaluated and statistically assessed. Subjects will also be asked to complete a questionnaire regarding their digestion after oral intake of ENSO 16 or glucose defined timepoints.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alpha Republic GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vienna General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457400
- Sponsor's protocol ID
- 00070007
- Status last verified
- Feb 2023
- First submitted
- 21 Mar 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Depends on the resources of the sponsor organization
Publications
Lutnik M, Weisshaar S, Mussbacher LM, Steiner D, Wolzt M. The substitute ENSO 16 has low impact on glucose metabolism in healthy humans: a randomized, double-blind, active-controlled, cross-over trial. Sci Rep. 2024 Jun 24;14(1):14534. doi: 10.1038/s41598-024-65560-w.
PubMed 38914694
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active-controlled, Cross-over Study to Assess the Effect of the Sugar Substitute "ENSO 16" on Glucose Metabolism Parameters in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05457400
- Acronym / sponsor ID
- 00070007
- Conditions
- Sugar; Blood, Low
- Keywords
- Sugar Substitutes, Fibers, Blood Glucose Rise, Blood Glucose Level, Polyols, Blood Glucose Spike
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Alpha Republic GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Vienna General Hospital
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 14 Jul 2022 (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 objective of this study is to evaluate differences in glucose metabolism parameters after oral administration of 30g glucose or 30g ENSO16. Blood samples will be be collected from 15 male or female subjects at defined time points (0 - 15 - 30 - 45 - 60 - 90 - 120
- 180 minutes; 3 min at each time point). Individual plasma glucose, insulin and C-peptide concentrations are going to be evaluated and statistically assessed. Subjects will also be asked to complete a questionnaire regarding their digestion after oral intake of ENSO 16 or glucose defined timepoints.
Detailed description
This is a randomized, double-blind, active-controlled, cross-over study to assess the effect of the sugar substitute "ENSO 16" on glucose metabolism parameters in healthy male or female subjects. 15 healthy subects ≥ 18 years will be included and 30 g of ENSO 16 or 30 g glucose will be orally administered to assess the impact on markers of glucose metabolism. The study medication will be dissolved in 200 mL tap water. After randomization, subjects will receive ENSO 16 (group A) or glucose (group B) on the first study day. Following a wash-out period of at least on week, subjects will receive glucose (group A) or ENSO 16 (group B) on the second study day. A screening examination (inclusion/ exclusion criteria, medical history, etc.) will be done on the first study day before the study medication will be administered. The study medication will be administered after an overnight fast of at least 10h. Subjects will receive a venular cannula and blood is going to be collected at 8 pre-defined timepoints (0 - 15 - 30 - 45 - 60 - 90 - 120 - 180 minutes; 3 min at each time point). In total, 192 mL of blood are going to be collected per study participant. Study participants will also have to fill in a questionnaire to rate gastrointestinal symptoms using a checklist including the following questions: ((a) abdominal pain, (b) nausea, (c) vomiting, (d) diarrhoea, (e) abdominal rumbling, (f) bloating, (g) belching and (h) flatulence. Participants were asked to choose between "no symptom" (0 points), "mild symptoms" (1 point) and "severe symptoms" (2 points) for each question at each time point.
Primary Endpoint To test the effect of orally administered ENSO 16 (30 g) or glucose (30 g) on plasma glucose levels. The area under the curve (AUC) of plasma glucose profiles (0-60 min) will be compared between different study days.
Null and alternative hypotheses:
H0: There is no difference in blood glucose AUC (0-60 min) between glucose and ENSO 16. H1: There is a difference in blood glucose AUC (0-60 min) between glucose and ENSO 16. Sample size calculation No formal sample size calculation could be performed for this trial as ENSO 16 has never been tested on glucose metabolism parameters in a clinical trial. There is evidence that sugar substitutes have to be studied separately because sweeteners differ considerably in their chemical structure and their physiologic effect on glucose metabolism. However, based on a cross-over trial with the sugar substitute xylitol at high doses, a sample size of 12 was appropriate to detect significant differences in outcome parameters. Based on these study results and on available statistical recommendations, a sample size of 15 was chosen, which is considered to be appropriate for this cross over trial to detect significant differences in the main outcome parameters if present. Statistical methodology Calculation of the AUC (0-60 min) for plasma glucose, insulin and Cpeptide profiles. Paired T-tests or Wilcoxon signed rank tests (for skewed distributions) will be applied to describe differences between treatments (glucose and ENSO 16)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The objective of this study is to evaluate differences in glucose metabolism parameters after oral administration of 30g glucose or 30g ENSO16. Blood samples will be be collected from 15 male or female subjects at defined time points (0 - 15 - 30 - 45 - 60 - 90 - 120 - 180 minutes; 3 min at each time point). Individual plasma glucose, insulin and C-peptide concentrations are going to be evaluated and statistically assessed. Subjects will also be asked to complete a questionnaire regarding their digestion after oral intake of ENSO 16 or glucose defined timepoints.
| Arm | Type | Receives |
|---|---|---|
| ENSO 16 | Active comparator | Drug: ENSO 16The participants receive 30g ENSO 16 dissolved in 200 mL water and blood will be collected at defined time points (0 - 15 - 30 - 45 - 60 - 90 - 120 - 180 minutes; ±3 min at each time point). |
| Glucose Powder | Active comparator | Drug: Glucose PowderThe participants receive Glucose in the same dosage and blood is also taken at the same time points. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability of subject to understand the character and individual consequences of the study;
- Signed informed consent before the start of any specific study procedures;
- Age ≥18 years;
- BMI 18-25 and healthy
- Fasting blood glucose ≤ 100mg/dL (point of care device)
Key exclusion criteria (7 listed)
- Substance or alcohol abuse
- Smoking
- Regular intake of medication (except oral contraceptives) including over the counter drugs within 2 weeks before study day 1
- Chronic medical illness
- Food allergies and dietary restrictions
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 |
|---|---|---|
| ENSO 1630 g ENSO 16 dissolved in Water | Drug | ENSO 16 |
| Glucose Powder30 g Glucose Powder dissolved in Water | Drug | Glucose Powder |
Primary outcome
Effect on blood sugar
Time frame: 2 weeks
To test the effect of orally administered ENSO 16 (30 g) or glucose (30 g) on plasma glucose levels. The area under the curve (AUC) of plasma glucose profiles (0-60 min) will be compared between different study days.
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 21 Feb 2023.
- Derived from this study: PubMed 38914694Lutnik M, Weisshaar S, Mussbacher LM, Steiner D, Wolzt M. The substitute ENSO 16 has low impact on glucose metabolism in healthy humans: a randomized, double-blind, active-controlled, cross-over trial. Sci Rep. 2024 Jun 24;14(1):14534. doi: 10.1038/s41598-024-65560-w.
- Individual participant dataSharing planned: Yes. Depends on the resources of the sponsor organization
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ENSO 16 and Glucose Powder in people with Sugar; Blood, Low, run by Alpha Republic GmbH at 1 site in Austria.
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 5 inclusion and 7 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 21 Feb 2023. 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 Austria. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effect on blood sugar (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05457400, which also lists 1 linked publication.
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 21 Feb 2023.