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

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

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.

Study Overview

• Status: Completed
• Conditions: Hunger; Blood Glucose, Low
• Intervention / Treatment: Other: Sucrose; Drug: Rebaudioside M; Drug: Lactisole

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Christian Doppler Laboratory for Taste Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sucrose; 10% solution in water	Other: Sucrose; 10% Sucrose corresponding to a regular soft drink; Other Names: table sugar
Experimental: Sucrose + Reb M; 10% sucrose + 60 mg/L Rebaudioside M	Other: Sucrose; 10% Sucrose corresponding to a regular soft drink; Other Names: table sugar; Drug: Rebaudioside M; Sweetener (increases sweetness); Other Names: CAS Number: 1220616-44-3
Experimental: Sucrose + Lactisole; 10% sucrose + 30 mg/ L Lactisole	Other: Sucrose; 10% Sucrose corresponding to a regular soft drink; Other Names: table sugar; Drug: Lactisole; sweet taste inhibitor (decreases sweetness); Other Names: 2-(4-methoxyphenoxy)propionic acid; CAS Number: 150436-68-3
Experimental: Sucrose + Reb M + Lactisole; 10% sucrose + 60 mg/L Rebaudioside M + 30 mg/ L Lactisole	Other: Sucrose; 10% Sucrose corresponding to a regular soft drink; Other Names: table sugar; Drug: Rebaudioside M; Sweetener (increases sweetness); Other Names: CAS Number: 1220616-44-3; Drug: Lactisole; sweet taste inhibitor (decreases sweetness); Other Names: 2-(4-methoxyphenoxy)propionic acid; CAS Number: 150436-68-3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food intake	Ad libitum Food intake from a standardized breakfast	120 minutes after drinking of the test solution
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

Collaborators and Investigators

• Sponsor: University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 706014-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No