Impact of Hesperetin in Combination With Sucrose on Energy Metabolism

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.

Study Overview

• Status: Completed
• Conditions: Hunger; Blood Glucose Fluctuations
• Intervention / Treatment: Other: Sucrose; Drug: Hesperetin

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Christian Doppler Laboratory for Taste Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sucrose; 10% (w/v) sucrose in water	Other: Sucrose; 10% sucrose corresponding to a regular soft drink; Other Names: table sugar
Experimental: Hesperetin; 7% (w/v) sucrose in water + 50 mg/L Hesperetin	Drug: Hesperetin; increases sweetness of 7% sucrose solution to match sweetness of 10% sucrose solution; Other Names: (2S)-3',5,7-Trihydroxy-4'-methoxyflavan-4-one; CAS number 520-33-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in food intake	Ad libitum food intake from a standardized breakfast	120 minutes after drinking of the test solution

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Vienna
• Investigators: Principal Investigator: Barbara Lieder, PhD, University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 706014-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No