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

Hunger Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04991714
• Other study ID #: 706014-1
• Status: Completed
• Phase: Early Phase 1
• Start date: August 5, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2023
• Source: University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 30, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Glucose, Low
• Hunger

Intervention

Drug:
• Lactisole
sweet taste inhibitor (decreases sweetness)
• Rebaudioside M
Sweetener (increases sweetness)

Other:
• Sucrose
10% Sucrose corresponding to a regular soft drink

Locations

Country	Name	City	State
Austria	Christian Doppler Laboratory for Taste Research	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose concentration	Glucose concentration [mg/dL] in plasma samples before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution	over a time span of 120 minutes after drinking the test solution
Primary	Insulin concentration	Insulin concentration [mmol/L] in plasma samples before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution	over a time span of 120 minutes after drinking the test solution
Primary	GLP-1 concentration	Glucagon-like peptide 1 concentration in plasma samples [mmol/L] before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution	over a time span of 120 minutes after drinking the test solution
Primary	GIP-concentration	Gastric inhibitory polypeptide concentration in plasma samples [mmol/L] before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution	over a time span of 120 minutes after drinking the test solution
Secondary	Food intake	Ad libitum Food intake from a standardized breakfast	120 minutes after drinking of the test solution
Secondary	Metabolic changes	Metabolome analysis in plasma samples [mmol/L] before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution	over a time span of 120 minutes after drinking the test solution