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Completed

NCT Number: NCT04991714

Effect of Sweetness Intensity of a Sucrose Solution on Blood Glucose Regulation and Energy Intake

The aim of the present study is to investigate the influence of the modulation of the sweetness intensity of a carbohydrate (sucrose)-containing solution on metabolic effects, in particular the regulation of blood glucose concentration and regulation of hunger & satiety.

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Key information

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 four interventions. The study investigates the influence of sweetness modulation by Rebaudioside M (sweetness enhancement) and Lactisol (sweetness inhibition) of a 10% sucrose solution, corresponding to the concentration of a regular soft drink, on blood glucose regulation (blood glucose concentration and regulating hormones) in healthy male volunteers. Furthermore, the study assesses ad libitum energy intake, individual feelings of hunger and satiety, metabolic responses to the interventions, and preference for sweet-tasting foods such as sugar and sweeteners. In addition, the participants' individual thresholds for sweet taste, as well as morphological markers for taste sensitivity and 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

Lactisole

Drug

sweet taste inhibitor (decreases sweetness)

Other names: 2-(4-methoxyphenoxy)propionic acid, CAS Number: 150436-68-3

Rebaudioside M

Drug

Sweetener (increases sweetness)

Other names: CAS Number: 1220616-44-3

Sucrose

Other

10% Sucrose corresponding to a regular soft drink

Other names: table sugar

Primary outcomes

  1. Blood glucose concentration

    Time frame: over a time span of 120 minutes after drinking the test solution

    Glucose concentration [mg/dL] in plasma samples before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution

  2. Insulin concentration

    Time frame: over a time span of 120 minutes after drinking the test solution

    Insulin concentration [mmol/L] in plasma samples before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution

  3. GLP-1 concentration

    Time frame: over a time span of 120 minutes after drinking the test solution

    Glucagon-like peptide 1 concentration in plasma samples [mmol/L] before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution

  4. GIP-concentration

    Time frame: over a time span of 120 minutes after drinking the test solution

    Gastric inhibitory polypeptide concentration in plasma samples [mmol/L] before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution

Secondary outcomes

  1. Food intake

    Time frame: 120 minutes after drinking of the test solution

    Ad libitum Food intake from a standardized breakfast

  2. Metabolic changes

    Time frame: over a time span of 120 minutes after drinking the test solution

    Metabolome analysis in plasma samples [mmol/L] before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution

Sponsors and collaborators

Lead sponsor

University of Vienna

Other

Registry information

Official study title

Einfluss Der Süßintensität Einer Saccharose-Lösung Auf Die Blutglukoseregulation Und Energieaufnahme in Gesunden Männern

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Aug 5, 2021
Registry last updated
Jan 26, 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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