Clinical trial NCT05279183: Assessment of Reward Responses to Erythritol Using Flavor Preference Learning
Official title: Assessment of Reward Responses to Erythritol Using Flavor Preference Learning and Its Effects on Gastrointestinal Hormones, Glycemic Control, Appetite-related Sensations and Emotional State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reward Responses
Gastrointestinal Hormones
Glycemic Control
Appetite
Satiation
Emotional State
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Assessment of the change of explicit wanting (reward response) to oral erythritol versus sucrose and sucralose as change from baseline to post-test visit.
timeFrame: from baseline to post-test visit (at t = 0min, t = 45min and t = 90min)
Secondary outcomes:
measure: Effects on reward response - explicit liking
timeFrame: The beverages will be consumed at t = 0min, t = 45min and t = 90min and afterwards explicit liking will be rated.
measure: Effects on reward response - desire to drink
timeFrame: The beverages will be consumed at t = 0min, t = 45min and t = 90min and afterwards desire to drink will be rated.
measure: Effects on reward response - implicit wanting
timeFrame: The computerized forced choice task will be performed at t = 135 min during the post-test visit.
measure: Effects on GI hormone response - GLP-1
timeFrame: Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.
measure: Effects on GI hormone response - PYY
timeFrame: Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.
measure: Effects on GI hormone response - CCK
timeFrame: Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.
measure: Effects on GI hormone response - ghrelin
timeFrame: Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.
measure: Effects on glycemic control - plasma glucose
timeFrame: Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.
measure: Effects on glycemic control - plasma insulin
timeFrame: Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.
measure: Effects on glycemic control - plasma c-peptide
timeFrame: Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.
measure: Effects on glycemic control - plasma glucagon
timeFrame: Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.
measure: Effects on appetite-related sensations (hunger, thirst, satiety)
timeFrame: Appetite-related sensations will be assessed at t = -1, 0, 15, 30, 44, 45, 60, 75, 89, 90, 105, 120, 134min.
measure: Emotional state
timeFrame: The emotional state will be assessed at t = -1, 0, 45, 90 min.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: St. Claraspital
Study officials:
affiliation: St. Clara Research Ltd.
name: Anne Christin Meyer-Gerspach, PD, PhD
role: PRINCIPAL_INVESTIGATOR
References: