Assessment of Reward Responses to Erythritol Using Flavor Preference Learning

NCT05279183 | Completed DMC

• 1 other identifier: PolyReward
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Assessment of the change of explicit wanting (reward response) to oral erythritol versus sucrose and sucralose as change from baseline to post-test visit.

  Beverages are consumed during the screening visit, conditioning visits and the post-test visit. The beverages will be consumed at t = 0min, t = 45min and t = 90min and afterwards explicit wanting will be assessed. Explicit wanting of the consumed beverages is assessed by Visual Analogue Scale (VAS) as "How much do you want to drink of the drink". The Visual Analogue Scale consists of a horizontal, unstructured, 10 cm line representing the minimum (0.0 points) labeled with "not much at all" to the maximum rating (10.0 points) labeled with "very much". Participants are instructed to draw a dash in the answer line to indicate the magnitude of their subjective sensation at the present time point.

  from baseline to post-test visit (at t = 0min, t = 45min and t = 90min)

Secondary Outcomes (13)

• Effects on reward response - explicit liking

  The beverages will be consumed at t = 0min, t = 45min and t = 90min and afterwards explicit liking will be rated.

• Effects on reward response - desire to drink

  The beverages will be consumed at t = 0min, t = 45min and t = 90min and afterwards desire to drink will be rated.

• Effects on reward response - implicit wanting

  The computerized forced choice task will be performed at t = 135 min during the post-test visit.

• Effects on GI hormone response - GLP-1

  Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.

• Effects on GI hormone response - PYY

  Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.

Study Arms (3)

Erythritol

ACTIVE COMPARATOR

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).

Dietary Supplement: Erythritol

Sucrose

ACTIVE COMPARATOR

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

Dietary Supplement: Sucrose

Sucralose

ACTIVE COMPARATOR

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).

Dietary Supplement: Sucralose

Interventions

Erythritol DIETARY_SUPPLEMENT

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

Also known as: E968-Erythritol

Erythritol

Sucrose DIETARY_SUPPLEMENT

30 g sucrose dissolved in 300 mL tap water.

Also known as: Saccharose

Sucrose

Sucralose DIETARY_SUPPLEMENT

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

Also known as: E955-Sucralose

Sucralose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• drinks rated as neutral and novel (from the flavor preference learning)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

St. Claraspital

Basel, 4002, Switzerland

Location

MeSH Terms

Interventions

Erythritol; Sucrose; trichlorosucrose

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Disaccharides; Oligosaccharides; Polysaccharides; Sugars

Study Officials

• Anne Christin Meyer-Gerspach, PD, PhD

  St. Clara Research Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 15, 2022
• Study Start: March 17, 2022
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)