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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Blood Glucose, Low, Hunger

Intervention / Treatment
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* Drug: Lactisole
* Drug: Rebaudioside M
* Other: Sucrose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |