NCT05705596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2023

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 31, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

January 17, 2023

Last Update Submit

November 27, 2023

Conditions

Blood Glucose FluctuationsHunger

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Change in blood glucose regulating hormones

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

  • Change in satiety hormones

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

  • Change in circulating miRNA

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

Study Arms (2)

Sucrose

EXPERIMENTAL

10% (w/v) sucrose in water

Other: Sucrose

Hesperetin

EXPERIMENTAL

7% (w/v) sucrose in water + 50 mg/L Hesperetin

Drug: Hesperetin

Interventions

SucroseOTHER

10% sucrose corresponding to a regular soft drink

Also known as: table sugar
Sucrose
HesperetinDRUG

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

Also known as: (2S)-3',5,7-Trihydroxy-4'-methoxyflavan-4-one, CAS number 520-33-2
Hesperetin

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • healthy
  • non-smoking
  • normal taste responses towards sweet taste

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christian Doppler Laboratory for Taste Research

Vienna, 1090, Austria

Location

Related Publications (1)

  • Gaider M, Kimmeswenger I, Schmidt J, Thines C, Wu A, Stoffl TK, Rust P, Ley JP, Krammer GE, Somoza V, Lieder B. Sucrose reduction with maintained sweetness level lowers glycemic fluctuations and energy intake in healthy males. Front Nutr. 2025 Nov 3;12:1682297. doi: 10.3389/fnut.2025.1682297. eCollection 2025.

    PMID: 41256921DERIVED

MeSH Terms

Interventions

SucroseDietary Sucrosehesperetin

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsDietary SugarsDietary CarbohydratesNutritive SweetenersSweetening AgentsFlavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Barbara Lieder, PhD

    University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Vice Chair Department of Physiological Chemistry

Study Record Dates

First Submitted

January 17, 2023

First Posted

January 31, 2023

Study Start

January 31, 2023

Primary Completion

June 30, 2023

Study Completion

November 15, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)