Impact of Hesperetin in Combination With Sucrose on Energy Metabolism

Early Phase 1

Completed

• Conditions: Blood Glucose Fluctuations; Hunger
• Interventions: Other: Sucrose; Drug: Hesperetin

• Registration Number: NCT05705596
• Lead Sponsor: University of Vienna

Brief 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.

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 Timeline

• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-01-26
• Study Start: 2023-01-31
• Study First Posted: 2023-01-31
• Primary Completion: 2023-06-30
• Status Verified: 2023-11
• Study Completion: 2023-11-15
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sucrose	Sucrose	10% (w/v) sucrose in water
Hesperetin	Hesperetin	7% (w/v) sucrose in water + 50 mg/L Hesperetin

Primary Outcome Measures

Name	Time	Method
Change in blood glucose concentration	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	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	120 minutes after drinking of the test solution	Ad libitum food intake from a standardized breakfast

Secondary Outcome Measures

Name	Time	Method
Change in satiety hormones	15, 30, 60, 90, and 120 minutes after drinking the test solution	Change compared to baseline in Polypeptide Y, grehlin, cholecystokinin, and serotonin concentrations \[mmol/L\] in plasma samples after drinking the test
Change in circulating miRNA	15, 30, 60, 90, and 120 minutes after drinking the test solution	Change compared to baseline in circulating extracellular vesicles and their miRNA composition
Change in blood glucose regulating hormones	15, 30, 60, 90, and 120 minutes after drinking the test solution	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

Trial Locations

Locations (1)

Christian Doppler Laboratory for Taste Research; 🇦🇹 Vienna, Austria