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Assessment of Reward Responses to Erythritol Using Flavor Preference Learning

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University Hospital Basel

Status

Completed

Conditions

Reward Responses
Emotional State
Glycemic Control
Gastrointestinal Hormones
Satiation
Appetite

Treatments

Dietary Supplement: Sucrose
Dietary Supplement: Erythritol
Dietary Supplement: Sucralose

Study type

Interventional

Funder types

Other

Identifiers

NCT05279183
PolyReward

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

20 participants in 3 patient groups

Erythritol
Active Comparator group
Description:
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).
Treatment:
Dietary Supplement: Erythritol
Sucrose
Active Comparator group
Description:
20 volunteers receive 30g sucrose dissolved in 300 mL tap water as oral preloads (3 times 100mL).
Treatment:
Dietary Supplement: Sucrose
Sucralose
Active Comparator group
Description:
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).
Treatment:
Dietary Supplement: Sucralose

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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