Blood Glucose FluctuationsEarly Phase 1NCT05705596
Impact of Hesperetin in Combination With Sucrose on Energy Metabolism
A Early Phase 1 study testing Sucrose and Hesperetin 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 the sweet-modulating substance hesperetin in combination with sucrose in comparison to an equally sweet-tasting sucrose-only solution on markers of energy metabolism. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose Fluctuations, Hunger
- What is being tested?
- Sucrose and Hesperetin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteAustria
- Study dates
- 31 Jan 2023to 15 Nov 2023
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- healthy
- non-smoking
- normal taste responses towards sweet taste
Who cannot join
- female
- 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.
About this study
Official title: Einfluss Des süßmodulierenden Polyphenols Hesperetin in Kombination Mit Saccharose Auf Die Blutglukose-Regulierung Und Energieaufnahme in Abhängigkeit Der Süßwahrnehmung
The aim of this cross-over intervention study is to investigate the influence of the sweet-modulating substance hesperetin in combination with sucrose in comparison to an equally sweet-tasting sucrose-only solution on markers of energy metabolism.
Read the detailed description
The study is designed as a randomised cross-over intervention study with two 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, 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 circulating extracellular vesicles and their miRNA composition 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
- Sucrose, Hesperetin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucroseOther
Also called table sugar
10% sucrose corresponding to a regular soft drink
HesperetinDrug
Also called (2S)-3',5,7-Trihydroxy-4'-methoxyflavan-4-one, CAS number 520-33-2
increases sweetness of 7% sucrose solution to match sweetness of 10% sucrose solution
| Study group | Role | What they receive |
|---|---|---|
| Sucrose | Experimental | 10% (w/v) sucrose in water Receives: Other: Sucrose |
| Hesperetin | Experimental | 7% (w/v) sucrose in water + 50 mg/L Hesperetin Receives: Drug: Hesperetin |
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 digital visual analog scale 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 (3)
Change in blood glucose regulating hormones
Change compared to baseline in Insulin, Glucagon-like peptide 1, and Gastric inhibitory polypeptide concentrations [mmol/L] in plasma samples after drinking the test solution
Measured: 15, 30, 60, 90, and 120 minutes after drinking the test solution
Change in satiety hormones
Change compared to baseline in Polypeptide Y, grehlin, cholecystokinin, and serotonin concentrations [mmol/L] in plasma samples after drinking the test
Measured: 15, 30, 60, 90, and 120 minutes after drinking the test solution
Change in circulating miRNA
Change compared to baseline in circulating extracellular vesicles and their miRNA composition
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 posted31 Jan 2023
- Study start31 Jan 2023
- Primary completion30 Jun 2023
- Study completion15 Nov 2023
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 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
- 33 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
- NCT05705596
- Sponsor's protocol ID
- 706014-2
- Status last verified
- Nov 2023
- First submitted
- 17 Jan 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaider M, Kimmeswenger I, Schmidt J, Thines C, Wu A, Stoffl TK, Rust P, Ley JP, Krammer GE, Somoza V, Lieder B. Sucrose reduction with maintained sweetness level lowers glycemic fluctuations and energy intake in healthy males. Front Nutr. 2025 Nov 3;12:1682297. doi: 10.3389/fnut.2025.1682297. eCollection 2025.
PubMed 41256921
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. 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
- ClinicalTrials.gov ID
- NCT05705596
- Acronym / sponsor ID
- 706014-2
- Conditions
- Blood Glucose Fluctuations, Hunger
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 31 Jan 2023 (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 the sweet-modulating substance hesperetin in combination with sucrose in comparison to an equally sweet-tasting sucrose-only solution on markers of energy metabolism.
Detailed description
The study is designed as a randomised cross-over intervention study with two 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, 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 circulating extracellular vesicles and their miRNA composition 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrose | Experimental | Other: Sucrose10% (w/v) sucrose in water |
| Hesperetin | Experimental | Drug: Hesperetin7% (w/v) sucrose in water + 50 mg/L Hesperetin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- male
- healthy
- non-smoking
- normal taste responses towards sweet taste
Key exclusion criteria (8 listed)
- female
- 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 |
|---|---|---|
| SucroseAlso: table sugar10% sucrose corresponding to a regular soft drink | Other | Sucrose |
| HesperetinAlso: (2S)-3',5,7-Trihydroxy-4'-methoxyflavan-4-one, CAS number 520-33-2increases sweetness of 7% sucrose solution to match sweetness of 10% sucrose solution | Drug | Hesperetin |
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 digital visual analog scale 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
3 secondary outcomes
Change in blood glucose regulating hormones
Time frame: 15, 30, 60, 90, and 120 minutes after drinking the test solution
Change in satiety hormones
Time frame: 15, 30, 60, 90, and 120 minutes after drinking the test solution
Change in circulating miRNA
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 28 Nov 2023.
- Derived from this study: PubMed 41256921Gaider M, Kimmeswenger I, Schmidt J, Thines C, Wu A, Stoffl TK, Rust P, Ley JP, Krammer GE, Somoza V, Lieder B. Sucrose reduction with maintained sweetness level lowers glycemic fluctuations and energy intake in healthy males. Front Nutr. 2025 Nov 3;12:1682297. doi: 10.3389/fnut.2025.1682297. eCollection 2025.
- 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 Sucrose and Hesperetin 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 4 inclusion and 8 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 28 Nov 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?
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?
On the ClinicalTrials.gov record for NCT05705596, 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 28 Nov 2023.