Impact of Hesperetin in Combination With Sucrose on Energy Metabolism

Hunger Clinical Trial

Official title:

Einfluss Des süßmodulierenden Polyphenols Hesperetin in Kombination Mit Saccharose Auf Die Blutglukose-Regulierung Und Energieaufnahme in Abhängigkeit Der Süßwahrnehmung

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05705596
• Other study ID #: 706014-2
• Status: Completed
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Blood Glucose Fluctuations
• Hunger

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