Impact Hesperetin in Combination with Sucrose on Blood Glucose Regulation

Early Phase 1CompletedNCT06340087

University of Vienna39 enrolled

Overview

The aim of this cross-over intervention study is to investigate the influence of hesperetin applied in combination with sucrose in comparison to an equally sweet-tasting sucrose-only solution and an isocaloric sucrose-only solution on markers of energy metabolism

The study is designed as a randomised cross-over intervention study with three 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, and a less sweet 7% sucrose solution w/o 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 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

10% SucroseOTHER

10% sucrose corresponding to a regular soft drink

Sucrose+ HesperetinDRUG

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

7% SucroseOTHER

7% sucrose to match the caloric content of the sugar-reduced hesperetin intervention

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * healthy * non-smoking * normal taste responses towards sweet taste Exclusion Criteria: * pregnancy or breast-feeding * 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, 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 unstructured, digital visual analog scale ranging from 0-10 cm 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 regulating hormones

Change compared to baseline in Insulin, Glucagon-like peptide 1, Gastric inhibitory polypeptide, and Polypetide Y 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

Data from ClinicalTrials.gov

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