An Early Phase 1 interventional study of 10% Sucrose and Sucrose+ Hesperetin in Blood Glucose Fluctuations and Hunger, sponsored by University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by University of Vienna · Early Phase 1, Interventional, and Basic science
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
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.
University of Vienna is the lead sponsor of 49 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
10% (w/v) sucrose in water
Other: 10% Sucrose
7% (w/v) sucrose in water + 50 mg/L Hesperetin
Drug: Sucrose+ Hesperetin
7% (w/v) sucrose in water
Other: 7% Sucrose
10% sucrose corresponding to a regular soft drink
Also known as: table sugar
Drug page: Sucrose
Addition of hesperetin increases sweetness of 7% sucrose solution to match sweetness of 10% sucrose solution
Also known as: (2S)-3',5,7-Trihydroxy-4'-methoxyflavan-4-one, CAS number 520-33-2
7% sucrose to match the caloric content of the sugar-reduced hesperetin intervention
Also known as: table sugar
Change in blood glucose concentration
Change compared to baseline in blood glucose concentration \[mg/dL\] in plasma samples after drinking the test solution
Time frame: 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
Time frame: Difference between before and 120 minutes after drinking of the test solution
Change in food intake
Ad libitum food intake from a standardized breakfast
Time frame: 120 minutes after drinking of the test solution
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
Time frame: 15, 30, 60, 90, and 120 minutes after drinking the test solution
Plan to share: No
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Ran from Mar 2024 to primary completion in Sep 2024, 5 months.
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sucrose
University of Vienna