Impact Hesperetin in Combination with Sucrose on Blood Glucose Regulation

NCT06340087 | Completed Early Phase 1

• 1 other identifier: 706014-3
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this cross-over intervention study is to investigate the influence of hesperetin applied in combination with sucrose in comparison to an equally sweet-tasting sucrose-only solution and an isocaloric sucrose-only solution on markers of energy metabolism

Conditions

Blood Glucose Fluctuations; Hunger

Outcome Measures

Primary Outcomes (3)

• 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 unstructured, digital visual analog scale ranging from 0-10 cm 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 Outcomes (1)

• Change in regulating hormones

  15, 30, 60, 90, and 120 minutes after drinking the test solution

Study Arms (3)

10% Sucrose

EXPERIMENTAL

10% (w/v) sucrose in water

Other: 10% Sucrose

Sucrose + Hesperetin

EXPERIMENTAL

7% (w/v) sucrose in water + 50 mg/L Hesperetin

Drug: Sucrose+ Hesperetin

7% sucrose

EXPERIMENTAL

7% (w/v) sucrose in water

Other: 7% Sucrose

Interventions

10% Sucrose OTHER

10% sucrose corresponding to a regular soft drink

Also known as: table sugar

10% Sucrose

Sucrose+ Hesperetin DRUG

Addition of hesperetin increases sweetness of 7% sucrose solution to match sweetness of 10% sucrose solution

Also known as: (2S)-3',5,7-Trihydroxy-4'-methoxyflavan-4-one, CAS number 520-33-2

Sucrose + Hesperetin

7% Sucrose OTHER

7% sucrose to match the caloric content of the sugar-reduced hesperetin intervention

Also known as: table sugar

7% sucrose

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• pregnancy or breast-feeding
• 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, Vienna, 1090, Austria

Location

MeSH Terms

Interventions

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: Professor and Vice Chair Department of Physiological Chemistry

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 1, 2024
• Study Start: March 31, 2024
• Primary Completion: September 30, 2024
• Study Completion: November 15, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)