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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05705596
Other study ID # 706014-2
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date January 31, 2023
Est. completion date November 15, 2023

Study information

Verified date November 2023
Source University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date November 15, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - male - healthy - non-smoking - normal taste responses towards sweet taste Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Sucrose
10% sucrose corresponding to a regular soft drink
Drug:
Hesperetin
increases sweetness of 7% sucrose solution to match sweetness of 10% sucrose solution

Locations

Country Name City State
Austria Christian Doppler Laboratory for Taste Research Vienna

Sponsors (1)

Lead Sponsor Collaborator
University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in blood glucose concentration Change compared to baseline in blood glucose concentration [mg/dL] in plasma samples after drinking the test solution 15, 30, 60, 90, and 120 minutes after drinking the test solution
Primary 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 Difference between before and 120 minutes after drinking of the test solution
Primary Change in food intake Ad libitum food intake from a standardized breakfast 120 minutes after drinking of the test solution
Secondary 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 15, 30, 60, 90, and 120 minutes after drinking the test solution
Secondary 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 15, 30, 60, 90, and 120 minutes after drinking the test solution
Secondary Change in circulating miRNA Change compared to baseline in circulating extracellular vesicles and their miRNA composition 15, 30, 60, 90, and 120 minutes after drinking the test solution
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