Blood Glucose FluctuationsEarly Phase 1NCT06340087
Impact Hesperetin in Combination with Sucrose on Blood Glucose Regulation
A Early Phase 1 study testing 10% Sucrose, Sucrose+ Hesperetin and 7% Sucrose in people with Blood Glucose Fluctuations and Hunger, run by University of Vienna at 1 site in Austria.
Trial summary
The aim of this cross-over intervention study is to investigate the influence of hesperetin applied in combination with sucrose in comparison to an equally sweet-tasting sucrose-only solution and an isocaloric sucrose-only solution on markers of energy metabolism Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose Fluctuations, Hunger
- What is being tested?
- 10% Sucrose, Sucrose+ Hesperetin and 7% Sucrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteAustria
- Study dates
- 31 Mar 2024to 15 Nov 2024
- Phase
- Early 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- non-smoking
- normal taste responses towards sweet taste
Who cannot join
- pregnancy or breast-feeding
- regular smokers
- disturbed glucose and/or lipid metabolism
- regular intake of medication
- known allergies against one of the test compounds
- ageusia alcohol or drug addiction intake of antibiotics within the past 2 months
Trial locations and contacts
1 site in 1 country.
Austria1 site
Christian Doppler Laboratory for Taste Research
Vienna, State of Vienna, 1090
About this study
Official title: Einfluss Des Süßmodulierenden Polyphenols Hesperetin in Kombination Mit Saccharose Auf Die Blutglukose-Regulierung Und Energieaufnahme in Abhängigkeit Der Süßwahrnehmung Teil 2
The aim of this cross-over intervention study is to investigate the influence of hesperetin applied in combination with sucrose in comparison to an equally sweet-tasting sucrose-only solution and an isocaloric sucrose-only solution on markers of energy metabolism
Read the detailed description
The study is designed as a randomised cross-over intervention study with three arms. The aim is to investigate the influence of a 10% sucrose solution, corresponding to the sugar content of a conventional soft drink, compared to an equally sweet-tasting 7% sucrose solution in combination with 50 mg/L of the polyphenol hesperetin, and a less sweet 7% sucrose solution w/o hesperetin on time-dependent blood glucose fluctuations and ad libitum energy intake in metabolically healthy male volunteers.
To investigate the underlying mechanisms, the individual appetite score, metabolic and hormonal responses to the interventions and will be measured. In addition, the participants' individual thresholds for sweet taste, preference and consumption for sweet-tasting foods such as sugar and sweeteners, and their body composition will be recorded as potential influencing factors.
- Conditions
- Blood Glucose Fluctuations, Hunger
- Being tested
- 10% Sucrose, Sucrose+ Hesperetin, 7% Sucrose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% SucroseOther
Also called table sugar
10% sucrose corresponding to a regular soft drink
Sucrose+ HesperetinDrug
Also called (2S)-3',5,7-Trihydroxy-4'-methoxyflavan-4-one, CAS number 520-33-2
Addition of hesperetin increases sweetness of 7% sucrose solution to match sweetness of 10% sucrose solution
7% SucroseOther
Also called table sugar
7% sucrose to match the caloric content of the sugar-reduced hesperetin intervention
| Study group | Role | What they receive |
|---|---|---|
| 10% Sucrose | Experimental | 10% (w/v) sucrose in water Receives: Other: 10% Sucrose |
| Sucrose + Hesperetin | Experimental | 7% (w/v) sucrose in water + 50 mg/L Hesperetin Receives: Drug: Sucrose+ Hesperetin |
| 7% sucrose | Experimental | 7% (w/v) sucrose in water Receives: Other: 7% Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose concentration
Change compared to baseline in blood glucose concentration [mg/dL] in plasma samples after drinking the test solution
Measured: 15, 30, 60, 90, and 120 minutes after drinking the test solution
Change in appetite score
Change compared to baseline in the subjective rating of the individual feeling of hunger, fullness, as well as appetite for a snack or for something sweet on a unstructured, digital visual analog scale ranging from 0-10 cm in comparison to baseline
Measured: Difference between before and 120 minutes after drinking of the test solution
Change in food intake
Ad libitum food intake from a standardized breakfast
Measured: 120 minutes after drinking of the test solution
Secondary outcomes (1)
Change in regulating hormones
Change compared to baseline in Insulin, Glucagon-like peptide 1, Gastric inhibitory polypeptide, and Polypetide Y concentrations [mmol/L] in plasma samples after drinking the test solution
Measured: 15, 30, 60, 90, and 120 minutes after drinking the test solution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start31 Mar 2024
- Primary completion30 Sep 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Glucose FluctuationsStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Lieder, University of Vienna
- Investigators
- Barbara Lieder, PhD, Principal investigator, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340087
- Sponsor's protocol ID
- 706014-3
- Status last verified
- Nov 2024
- First submitted
- 24 Mar 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- 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 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Einfluss Des Süßmodulierenden Polyphenols Hesperetin in Kombination Mit Saccharose Auf Die Blutglukose-Regulierung Und Energieaufnahme in Abhängigkeit Der Süßwahrnehmung Teil 2
- ClinicalTrials.gov ID
- NCT06340087
- Acronym / sponsor ID
- 706014-3
- Conditions
- Blood Glucose Fluctuations, Hunger
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- 31 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 1 Apr 2024 (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 cross-over intervention study is to investigate the influence of hesperetin applied in combination with sucrose in comparison to an equally sweet-tasting sucrose-only solution and an isocaloric sucrose-only solution on markers of energy metabolism
Detailed description
The study is designed as a randomised cross-over intervention study with three arms. The aim is to investigate the influence of a 10% sucrose solution, corresponding to the sugar content of a conventional soft drink, compared to an equally sweet-tasting 7% sucrose solution in combination with 50 mg/L of the polyphenol hesperetin, and a less sweet 7% sucrose solution w/o hesperetin on time-dependent blood glucose fluctuations and ad libitum energy intake in metabolically healthy male volunteers.
To investigate the underlying mechanisms, the individual appetite score, metabolic and hormonal responses to the interventions and will be measured. In addition, the participants' individual thresholds for sweet taste, preference and consumption for sweet-tasting foods such as sugar and sweeteners, and their body composition will be recorded as potential influencing factors.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10% Sucrose | Experimental | Other: 10% Sucrose10% (w/v) sucrose in water |
| Sucrose + Hesperetin | Experimental | Drug: Sucrose+ Hesperetin7% (w/v) sucrose in water + 50 mg/L Hesperetin |
| 7% sucrose | Experimental | Other: 7% Sucrose7% (w/v) sucrose in water |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy
- non-smoking
- normal taste responses towards sweet taste
Key exclusion criteria (6 listed)
- pregnancy or breast-feeding
- regular smokers
- disturbed glucose and/or lipid metabolism
- regular intake of medication
- known allergies against one of the test compounds
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 |
|---|---|---|
| 10% SucroseAlso: table sugar10% sucrose corresponding to a regular soft drink | Other | 10% Sucrose |
| Sucrose+ HesperetinAlso: (2S)-3',5,7-Trihydroxy-4'-methoxyflavan-4-one, CAS number 520-33-2Addition of hesperetin increases sweetness of 7% sucrose solution to match sweetness of 10% sucrose solution | Drug | Sucrose + Hesperetin |
| 7% SucroseAlso: table sugar7% sucrose to match the caloric content of the sugar-reduced hesperetin intervention | Other | 7% sucrose |
Primary outcome
Change in blood glucose concentration
Time frame: 15, 30, 60, 90, and 120 minutes after drinking the test solution
Change compared to baseline in blood glucose concentration [mg/dL] in plasma samples after drinking the test solution
Change in appetite score
Time frame: Difference between before and 120 minutes after drinking of the test solution
Change compared to baseline in the subjective rating of the individual feeling of hunger, fullness, as well as appetite for a snack or for something sweet on a unstructured, digital visual analog scale ranging from 0-10 cm in comparison to baseline
Change in food intake
Time frame: 120 minutes after drinking of the test solution
Ad libitum food intake from a standardized breakfast
1 secondary outcome
Change in regulating hormones
Time frame: 15, 30, 60, 90, and 120 minutes after drinking the test solution
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 25 Nov 2024.
- 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.
Barbara Lieder, PhD principal investigator
University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 10% Sucrose, Sucrose+ Hesperetin and 7% Sucrose in people with Blood Glucose Fluctuations and Hunger, run by University of Vienna 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 3 inclusion and 6 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 25 Nov 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in blood glucose concentration (time frame: 15, 30, 60, 90, and 120 minutes after drinking the test solution). The study lists 3 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 25 Nov 2024.