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Completed

NCT Number: NCT06340087

Impact Hesperetin in Combination with Sucrose on Blood Glucose Regulation

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

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Key information

Conditions

Blood Glucose Fluctuations Hunger

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Christian Doppler Laboratory for Taste Research

Vienna, State of Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10% Sucrose

Other

10% sucrose corresponding to a regular soft drink

Other names: table sugar

Sucrose+ Hesperetin

Drug

Addition of 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

7% Sucrose

Other

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

Other names: table sugar

Primary outcomes

  1. Change in blood glucose concentration

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

    Change compared to baseline in blood glucose concentration [mg/dL] in plasma samples after drinking the test solution

  2. Change in appetite score

    Time frame: Difference between before and 120 minutes after drinking of the test solution

    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

  3. Change in food intake

    Time frame: 120 minutes after drinking of the test solution

    Ad libitum food intake from a standardized breakfast

Secondary outcomes

  1. Change in regulating hormones

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

    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

Sponsors and collaborators

Lead sponsor

University of Vienna

Other

Registry information

Official study title

Einfluss Des Süßmodulierenden Polyphenols Hesperetin in Kombination Mit Saccharose Auf Die Blutglukose-Regulierung Und Energieaufnahme in Abhängigkeit Der Süßwahrnehmung Teil 2

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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