Clinical trial NCT05705596: Impact of Hesperetin in Combination With Sucrose on Energy Metabolism
Official title: Einfluss Des süßmodulierenden Polyphenols Hesperetin in Kombination Mit Saccharose Auf Die Blutglukose-Regulierung Und Energieaufnahme in Abhängigkeit Der Süßwahrnehmung
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Blood Glucose Fluctuations
Hunger
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in blood glucose concentration
timeFrame: 15, 30, 60, 90, and 120 minutes after drinking the test solution
measure: Change in appetite score
timeFrame: Difference between before and 120 minutes after drinking of the test solution
measure: Change in food intake
timeFrame: 120 minutes after drinking of the test solution
Secondary outcomes:
measure: Change in blood glucose regulating hormones
timeFrame: 15, 30, 60, 90, and 120 minutes after drinking the test solution
measure: Change in satiety hormones
timeFrame: 15, 30, 60, 90, and 120 minutes after drinking the test solution
measure: Change in circulating miRNA
timeFrame: 15, 30, 60, 90, and 120 minutes after drinking the test solution
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Christian Doppler Laboratory for Taste Research
Study officials:
affiliation: University of Vienna
name: Barbara Lieder, PhD
role: PRINCIPAL_INVESTIGATOR
References: