Impact of Hesperetin in Combination With Sucrose on Energy Metabolism

Study Overview
=================
Brief Summary
-----------------
The aim of this cross-over intervention study is to investigate the influence of the sweet-modulating substance hesperetin in combination with sucrose in comparison to an equally sweet-tasting sucrose-only solution on markers of energy metabolism.

Detailed Description
-----------------
The study is designed as a randomised cross-over intervention study with two arms. The aim is to investigate the influence of a 10% sucrose solution, corresponding to the sugar content of a conventional soft drink, compared to an equally sweet-tasting 7% sucrose solution in combination with 50 mg/L of the polyphenol hesperetin, on time-dependent blood glucose fluctuations and ad libitum energy intake in metabolically healthy male volunteers. To investigate the underlying mechanisms, the individual appetite score, metabolic and hormonal responses to the interventions and circulating extracellular vesicles and their miRNA composition will be measured. In addition, the participants' individual thresholds for sweet taste, preference and consumption for sweet-tasting foods such as sugar and sweeteners, and their body composition will be recorded as potential influencing factors.

Official Title
-----------------
Einfluss Des süßmodulierenden Polyphenols Hesperetin in Kombination Mit Saccharose Auf Die Blutglukose-Regulierung Und Energieaufnahme in Abhängigkeit Der Süßwahrnehmung

Conditions
-----------------
Blood Glucose Fluctuations, Hunger

Intervention / Treatment
-----------------
* Other: Sucrose
* Drug: Hesperetin


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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% (w/v) sucrose in water | Other: Sucrose<br>* 10% sucrose corresponding to a regular soft drink<br>* Other names: table sugar;|
| Experimental: Hesperetin<br>7% (w/v) sucrose in water + 50 mg/L Hesperetin | Drug: Hesperetin<br>* increases sweetness of 7% sucrose solution to match sweetness of 10% sucrose solution<br>* Other names: CAS number 520-33-2;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood glucose concentration | Change compared to baseline in blood glucose concentration [mg/dL] in plasma samples after drinking the test solution | 15, 30, 60, 90, and 120 minutes after drinking the test solution | 
| Change in appetite score | Change compared to baseline in the subjective rating of the individual feeling of hunger, fullness, as well as appetite for a snack or for something sweet on a digital visual analog scale in comparison to baseline | Difference between before and 120 minutes after drinking of the test solution | 
| Change in food intake | Ad libitum food intake from a standardized breakfast | 120 minutes after drinking of the test solution | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood glucose regulating hormones | Change compared to baseline in Insulin, Glucagon-like peptide 1, and Gastric inhibitory polypeptide concentrations [mmol/L] in plasma samples after drinking the test solution | 15, 30, 60, 90, and 120 minutes after drinking the test solution | 
| Change in satiety hormones | Change compared to baseline in Polypeptide Y, grehlin, cholecystokinin, and serotonin concentrations [mmol/L] in plasma samples after drinking the test | 15, 30, 60, 90, and 120 minutes after drinking the test solution | 
| Change in circulating miRNA | Change compared to baseline in circulating extracellular vesicles and their miRNA composition | 15, 30, 60, 90, and 120 minutes after drinking the test solution |