Impact of Hesperetin in Combination With Sucrose on Energy Metabolism

Early Phase 1CompletedNCT05705596

University of Vienna33 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Blood Glucose Fluctuations Hunger

Interventions

SucroseOTHER

10% sucrose corresponding to a regular soft drink

HesperetinDRUG

increases sweetness of 7% sucrose solution to match sweetness of 10% sucrose solution

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Christian Doppler Laboratory for Taste Research

Vienna, Austria

Outcomes

Primary Outcomes

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 digital visual analog scale 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

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 15, 30, 60, 90, and 120 minutes after drinking the test solution

Data from ClinicalTrials.gov

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