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Impact of Hesperetin in Combination With Sucrose on Energy Metabolism

NCT ID: NCT05705596

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2023-11-15

Brief Summary

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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

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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.

Conditions

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Blood Glucose Fluctuations Hunger

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sucrose

10% (w/v) sucrose in water

Group Type EXPERIMENTAL

Sucrose

Intervention Type OTHER

10% sucrose corresponding to a regular soft drink

Hesperetin

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

Group Type EXPERIMENTAL

Hesperetin

Intervention Type DRUG

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

Interventions

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Sucrose

10% sucrose corresponding to a regular soft drink

Intervention Type OTHER

Hesperetin

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

Intervention Type DRUG

Other Intervention Names

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table sugar (2S)-3',5,7-Trihydroxy-4'-methoxyflavan-4-one CAS number 520-33-2

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Barbara Lieder

Professor and Vice Chair Department of Physiological Chemistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara Lieder, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vienna

Locations

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Christian Doppler Laboratory for Taste Research

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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706014-2

Identifier Type: -

Identifier Source: org_study_id