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Completed

NCT Number: NCT05705596

Impact of Hesperetin in Combination With Sucrose on Energy Metabolism

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.

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Key information

Conditions

Blood Glucose Fluctuations Hunger

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Christian Doppler Laboratory for Taste Research

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Sucrose

Other

10% sucrose corresponding to a regular soft drink

Other names: table sugar

Hesperetin

Drug

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

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 digital visual analog scale 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 blood glucose 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, and Gastric inhibitory polypeptide concentrations [mmol/L] in plasma samples after drinking the test solution

  2. Change in satiety hormones

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

    Change compared to baseline in Polypeptide Y, grehlin, cholecystokinin, and serotonin concentrations [mmol/L] in plasma samples after drinking the test

  3. Change in circulating miRNA

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

    Change compared to baseline in circulating extracellular vesicles and their miRNA composition

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2023
Registry last updated
Nov 28, 2023

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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