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

NCT04991714 | Completed Early Phase 1

• 1 other identifier: 706014-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Glucose, Low; Hunger

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Food intake

  120 minutes after drinking of the test solution

• Metabolic changes

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

Study Arms (4)

Sucrose

EXPERIMENTAL

10% solution in water

Other: Sucrose

Sucrose + Reb M

EXPERIMENTAL

10% sucrose + 60 mg/L Rebaudioside M

Drug: Rebaudioside M; Other: Sucrose

Sucrose + Lactisole

EXPERIMENTAL

10% sucrose + 30 mg/ L Lactisole

Drug: Lactisole; Other: Sucrose

Sucrose + Reb M + Lactisole

EXPERIMENTAL

10% sucrose + 60 mg/L Rebaudioside M + 30 mg/ L Lactisole

Drug: Lactisole; Drug: Rebaudioside M; Other: Sucrose

Interventions

Lactisole DRUG

sweet taste inhibitor (decreases sweetness)

Also known as: 2-(4-methoxyphenoxy)propionic acid, CAS Number: 150436-68-3

Sucrose + Lactisole; Sucrose + Reb M + Lactisole

Rebaudioside M DRUG

Sweetener (increases sweetness)

Also known as: CAS Number: 1220616-44-3

Sucrose + Reb M; Sucrose + Reb M + Lactisole

Sucrose OTHER

10% Sucrose corresponding to a regular soft drink

Also known as: table sugar

Sucrose; Sucrose + Lactisole; Sucrose + Reb M; Sucrose + Reb M + Lactisole

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• male
• healthy
• non-smoking
• normal taste responses towards sweet taste

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vienna: lead

Study Sites (1)

Christian Doppler Laboratory for Taste Research

Vienna, 1090, Austria

Location

MeSH Terms

Interventions

lactisole; rebaudioside M; Sucrose; Dietary Sucrose

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Dietary Sugars; Dietary Carbohydrates; Nutritive Sweeteners; Sweetening Agents; Flavoring Agents; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Barbara Lieder, PhD

  University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deptuy Head Department of Physiological Chemistry

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 5, 2021
• Study Start: August 5, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 30, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)