Assessment of Reward Responses to Erythritol Using Flavor Preference Learning

NCT ID: NCT05279183

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-17
• Study Completion Date: 2022-09-16

Brief Summary

The aim of this project is to investigate the reward responses to oral erythritol compared to sucrose and sucralose using flavor preference learning in healthy participants. In addition, the release of GI hormones, glycemic control, appetite-related sensations, and emotional state in response to erythritol will be investigated.

Detailed Description

This trial is a randomized, double-blind, cross-over study; the project set-up will be single-centre, national. The study is composed of six visits: one screening visit, one pre-test visit, three conditioning visits, and one post-test visit. The screening and pre-test will last about two hours, the conditioning days and the post-test day about 4 hours each. During the screening participants take part in a 6-n-propylthiouracil (PROP) sensitivity test to exclude potential supertasters. Moreover, the participants will rate explicit liking and explicit wanting of 10 non-caloric flavored and colored beverages in a randomized order (flavor preference learning). The pre-test visit consists of two parts. First, a chemosensory sweetness matching will be performed, during which we will establish dose-response relationships for perceived sweetness of sucrose, erythritol, and sucralose using equisweet watery solutions across a range of concentrations. Second, the participants will perform a triangle test to ensure that they cannot distinguish the matched erythritol and sucralose solutions from a 10% sucrose solution.

During the 3 conditioning visits, participants will be presented with three conditioning trials (at t = 0, 45, and 90min), each consisting of drinking 100mL of the flavored drink (CS) paired with one of the sweet substances (US = erythritol, sucrose, or sucralose).

In post-test visit, preference for each of the 3 flavored CS drinks will be assessed and a computerized forced choice task will be completed by the participants.

Conditions

Reward Responses; Gastrointestinal Hormones; Glycemic Control; Appetite; Satiation; Emotional State

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Erythritol

20 volunteers receive erythritol dissolved in 300 mL tap water as oral preloads (3 times 100mL). The dosage will be calculated based on the participants ratings of the sweetness intensity (matched sweetness to 10 % sucrose).

Group Type: ACTIVE_COMPARATOR

Erythritol

Intervention Type: DIETARY_SUPPLEMENT

Subject specific dose of erythritol dissolved in 300 mL tap water.

Sucrose

20 volunteers receive 30g sucrose dissolved in 300 mL tap water as oral preloads (3 times 100mL).

Group Type: ACTIVE_COMPARATOR

Sucrose

Intervention Type: DIETARY_SUPPLEMENT

30 g sucrose dissolved in 300 mL tap water.

Sucralose

20 volunteers receive sucralose dissolved in 300 mL tap water as oral preloads (3 times 100mL). The dosage will be calculated based on the participants ratings of the sweetness intensity (matched sweetness to 10 % sucrose).

Group Type: ACTIVE_COMPARATOR

Sucralose

Intervention Type: DIETARY_SUPPLEMENT

Subject specific dose of sucralose dissolved in 300 mL tap water.

Interventions

Erythritol

Subject specific dose of erythritol dissolved in 300 mL tap water.

Intervention Type: DIETARY_SUPPLEMENT

Sucrose

30 g sucrose dissolved in 300 mL tap water.

Intervention Type: DIETARY_SUPPLEMENT

Sucralose

Subject specific dose of sucralose dissolved in 300 mL tap water.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

E968-Erythritol; Saccharose; E955-Sucralose

Eligibility Criteria

Inclusion Criteria

• Healthy normal weight participants with a body-mass index (BMI) of 19.0-24.9 kg/m2
• Age 18-55 years
• Stable body weight (±5%) for at least three months
• Able to give informed consent as documented by signature
• 3 drinks rated as neutral and novel (from the flavor preference learning)

Exclusion Criteria

• Non-taster (deficits of taste and smell) or supertaster
• Fructose intolerance
• Shift worker
• Pre-existing regular consumption of erythritol and/or sucralose and/or aspartame (>1/week)
• Substance abuse (more than 1 glass wine/beer per day; consumption of cannabis, cocaine, heroin, etc.)
• Regular intake of medications, except contraceptives
• Chronic or clinically relevant acute infections
• Pregnancy: although no contraindication, pregnancy might influence metabolic state.
• Participation in another study with investigational drug within the 30 days preceding and during the present study
• Pre-existing diet (vegetarian, vegan, sugar free)
• Inability to follow procedures due to psychological disorders or insufficient knowledge of project language (German)
• Calculated dose of erythritol outside the range of 30-60g (per 300mL) (from the sweetness matching)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Christin Meyer-Gerspach, PD, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Clara Research Ltd.

Locations

St. Claraspital

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

PolyReward

Identifier Type: -

Identifier Source: org_study_id