Reward ResponsesNCT05279183
Assessment of Reward Responses to Erythritol Using Flavor Preference Learning
A study testing Erythritol, Sucrose and Sucralose in people with Reward Responses and Gastrointestinal Hormones, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Reward Responses, Gastrointestinal Hormones, Glycemic Control
- What is being tested?
- Erythritol, Sucrose and Sucralose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Mar 2022to 16 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Erythritol, Sucrose, Sucralose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythritolDietary supplement
Also called E968-Erythritol
Subject specific dose of erythritol dissolved in 300 mL tap water.
SucroseDietary supplement
Also called Saccharose
30 g sucrose dissolved in 300 mL tap water.
SucraloseDietary supplement
Also called E955-Sucralose
Subject specific dose of sucralose dissolved in 300 mL tap water.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: Erythritol |
| Sucrose | Active comparator | 20 volunteers receive 30g sucrose dissolved in 300 mL tap water as oral preloads (3 times 100mL). Receives: 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). Receives: Dietary Supplement: Sucralose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to post-test visit (at t = 0min, t = 45min and t = 90min)
Secondary outcomes (13)
Effects on reward response - explicit liking
Beverages are consumed at the screening visit (during the flavor preference learning), conditioning visits and the post-test visit.
Explicit liking of the consumed beverages during the screening visit, the conditioning visits and post-test visit is rated from -100 to 100 using the Global Hedonic Intensity Scale (GHIS). The Global Hedonic Intensity Scale ranges from -100 "the most intensive disliking ever experienced" to 100 "most intensive liking ever experienced" and has no anchors and in the middle is 0 as a neutral point. Participants are instructed to draw a dash in the answer line to indicate the magnitude of their subjective liking at the present time point.
Measured: 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
Beverages are consumed at the screening visit (during the flavor preference learning), conditioning visits and the post-test visit.
During the post-test visit, the desire to drink will be recorded with a 10 cm Visual Analogue Scale (VAS) as "How strong is your desire to drink, that is, to taste and swallow, the rest of the drink RIGHT NOW? (Take a sip of the drink first)". The Visual Analogue Scale consists of a horizontal, unstructured, 10 cm line representing the minimum (0.0 points) labeled with "not strong at all" to the maximum rating (10.0 points) labeled with "very strong". Participants are instructed to draw a dash in the answer line to indicate the magnitude of their subjective sensation at the present time point.
Measured: 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
Implicit wanting will be measured at the end of the post-test visit by using a computerized forced choice task. Participants will be shown a paired presentation of three drinks where they have to select their most wanted drink ("select the drink which you would most want to drink right now"). In the four presentation parts, participants will have to choose between e.g. red bull drink vs. diet coke vs. fanta, or between diet coke vs. orange juice vs. ice tea. During the fifth presentation, pictures of the previous conditioned drinks will be shown and participants have to choose the drink which they would most want to drink right now. During the choice task, the chosen drink and the reaction time with which this drink was chosen (implicit wanting) will be measured.
Measured: The computerized forced choice task will be performed at t = 135 min during the post-test visit.
Effects on GI hormone response - GLP-1
Plasma GLP-1 will be quantified using a non-radioactive high sensitive sandwich ELISA (Millipore - # EZGLPHS-35K) in the presence of a chemiluminescent substrate.
Measured: 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
PYY-3-36 will be quantified using a non-radioactive high sensitive sandwich ELISA (Millipore - # EZHPYYT66K).
Measured: 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 - CCK
Plasma cholecystokinin (CCK) levels will be measured with a sensitive radioimmunoassay using a highly specific antiserum (No. 92128)
Measured: 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 - ghrelin
Octanoylated ghrelin will be measured by a radioimmunoassay with 125I [Tyr24] human ghrelin [1-23] as tracer and a rabbit antibody against human ghrelin [1-8] (final dilution 1/100000), which does not cross-react with desoctanoylated ghrelin.
Measured: Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.
Effects on glycemic control - plasma glucose
Glucose will be measured by a glucose oxidase method (Rothen Medizinische Laboratorien AG, Basel, Switzerland).
Measured: Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.
Effects on glycemic control - plasma insulin
Insulin will be quantified using a chemiluminescent microparticle immunoassay (chemiflex) reagent kit (#8k41; Abbott) and the relative light units detected by the ARCHITECT optical system (model: CI4100; Abbott).
Measured: Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.
Effects on glycemic control - plasma c-peptide
C-peptide will be measured with a commercially available sandwich ELISA kit from Millipore (Millipore - # EZHCP-20K).
Measured: Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.
Effects on glycemic control - plasma glucagon
Glucagon concentrations in plasma will be measured after extraction of plasma with 70% ethanol (vol/vol, final concentration). The antibody is directed against the C-terminus of the glucagon molecule (antibody code no. 4305) and therefore mainly measures glucagon of pancreatic origin.
Measured: Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.
Effects on appetite-related sensations (hunger, thirst, satiety)
Hunger, thirst, and satiety are assessed by VASs. VASs consist of a horizontal, unstructured, 10cm line representing the minimum (0.0 points) to the maximum rating (10.0 points). Participants are instructed to draw a dash in the answer line to indicate the magnitude of their subjective sensation at the present time point. The measurement is quantified by the distance from the left end of the line (minimum rating) to the participant's vertical mark.
Measured: Appetite-related sensations will be assessed at t = -1, 0, 15, 30, 44, 45, 60, 75, 89, 90, 105, 120, 134min.
Emotional state
Emotional state will be recorded with the self-assessment manikin (SAM). The self-assessment manikin is a non-verbal pictorial assessment technique using figures that directly measure the pleasure associated with a person's affective reaction to a variety of stimuli. The SAM represent a 9-point scale. The five figures used in this study range from unhappy (0) to happy (9). To indicate their emotional state at a certain time point, participants can select any of the figures or between any of the figures.
Measured: The emotional state will be assessed at t = -1, 0, 45, 90 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start17 Mar 2022
- Primary completion16 Sep 2022
- Study completion16 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reward ResponsesStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Christin Meyer-Gerspach, PD, PhD, Principal investigator, St. Clara Research Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279183
- Sponsor's protocol ID
- PolyReward
- Status last verified
- Oct 2022
- First submitted
- 14 Feb 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05279183
- Acronym / sponsor ID
- PolyReward
- Conditions
- Reward Responses, Gastrointestinal Hormones, Glycemic Control, Appetite, Satiation, Emotional State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 16 Sep 2022 (actual)
- Study completion
- 16 Sep 2022 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Erythritol | Active comparator | Dietary Supplement: Erythritol20 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). |
| Sucrose | Active comparator | Dietary Supplement: Sucrose20 volunteers receive 30g sucrose dissolved in 300 mL tap water as oral preloads (3 times 100mL). |
| Sucralose | Active comparator | Dietary Supplement: Sucralose20 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErythritolAlso: E968-ErythritolSubject specific dose of erythritol dissolved in 300 mL tap water. | Dietary supplement | Erythritol |
| SucroseAlso: Saccharose30 g sucrose dissolved in 300 mL tap water. | Dietary supplement | Sucrose |
| SucraloseAlso: E955-SucraloseSubject specific dose of sucralose dissolved in 300 mL tap water. | Dietary supplement | Sucralose |
Primary outcome
Assessment of the change of explicit wanting (reward response) to oral erythritol versus sucrose and sucralose as change from baseline to post-test visit.
Time frame: from baseline to post-test visit (at t = 0min, t = 45min and t = 90min)
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.
13 secondary outcomes
Effects on reward response - explicit liking
Time frame: 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
Time frame: 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
Time frame: The computerized forced choice task will be performed at t = 135 min during the post-test visit.
Effects on GI hormone response - GLP-1
Time frame: 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
Time frame: 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 - CCK
Time frame: 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 - ghrelin
Time frame: Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.
Effects on glycemic control - plasma glucose
Time frame: Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.
Effects on glycemic control - plasma insulin
Time frame: Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.
Effects on glycemic control - plasma c-peptide
Time frame: Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.
Effects on glycemic control - plasma glucagon
Time frame: Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.
Effects on appetite-related sensations (hunger, thirst, satiety)
Time frame: Appetite-related sensations will be assessed at t = -1, 0, 15, 30, 44, 45, 60, 75, 89, 90, 105, 120, 134min.
Emotional state
Time frame: The emotional state will be assessed at t = -1, 0, 45, 90 min.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Christin Meyer-Gerspach, PD, PhD principal investigator
St. Clara Research Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erythritol, Sucrose and Sucralose in people with Reward Responses and Gastrointestinal Hormones, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: from baseline to post-test visit (at t = 0min, t = 45min and t = 90min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.