ObesityNCT04162457
Mapping the 'Sweet Brain' in Healthy Participants
A study testing Stevia, Glucose and Maltodextrin in people with Obesity and Sweeteners, run by University of Manchester at 1 site in United Kingdom.
Trial summary
The human brain has a central role in regulating appetite and food intake. It integrates many metabolic, hedonic and trait-related signals that affect eating behaviour and determine when and how much we eat. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Sweeteners
- What is being tested?
- Stevia, Glucose and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Nov 2019to 31 Mar 2021
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 - 40 years
- BMI between 18.5-25 kg/m2
- Registered to a GP
- Non-restrained eaters, restraint eating score on the Dutch Eating Behaviour Questionnaire (DEBQ) ≤ 3
- Healthy - general good health
- Currently not taking any medication (other than females taking the oral contraceptives or over the counter medication such as paracetamol)
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- Normal or corrected vision
- Right-handedness (including left-handers could bias the results because of the laterality of brain functions)
- Regular breakfast eaters (≥5 times per week)
- Stable weight, ± 5 kg last 3 months
- No self-reported food allergy or intolerance to foods supplied during the study
- No or low NNS consumers (up to 1 can of diet soda per week or 1 sachet of NNS per week)
- Willing to comply with the study protocol
- Willingness to be informed about chance findings of pathology
- The participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- The participant is able to read, comprehend and record information written in English.
- A signed and dated written informed consent is obtained from the participant.
Who cannot join
- Habitual NNS consumers, >1 can of diet beverage or >1 table packet of sweeteners per week
- Subjects who have a non-removable metal object in or at their body, such as, for example: heart pace-maker, artificial heart valve, metal prosthesis, implants or splinters, non-removable dental braces
- Tattoos, that are older than 15 years
- Claustrophobia
- Pathological hearing ability or an increased sensitivity to loud noises
- Operation less than 3 months ago
Show all 21Show fewer
- Acute illness or infection during the last 4 weeks
- Moderate or severe head injury
- Any metabolic (e.g. metabolic disorder, diabetes, insulin resistance), psychological (e.g. depression), gastrointestinal or neurological (e.g. epilepsy, headache disorder, multiple sclerosis, traumatic brain injuries) diseases or medication in relation to these diseases.
- Currently experiencing anxiety or depression
- Use of recreational substances in the last month
- Age under 18 years or over 40 years old.
- BMI >25 kg/m2 and <18.5 kg/m2
- Restrained eaters (DEBQ for restraint eating ≥ 3)
- Current weight loss regimens, or more than 5 kg weight loss/gain in the last 3 months
- Subjects who follow special diets for weight maintenance, such as Atkins Diet, Weight Watchers, gluten-free diet, The Zone diet, Vegetarian Diet, Raw Food Diet etc.
- Subjects having breakfast less than 5 times per week.
- Eating disorders (binge eating disorder, bulimia etc)
- Current or past history of drug or alcohol dependency - alcohol consumption exceeding 14 units a week
- Female participants who are, or may be, pregnant, or currently lactating.
- Subjects who regularly consume dietary supplements for weight loss, muscle building etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Caloric and Non-caloric Sweet Preloads on Neural Correlates of Physiological and Neurocognitive Responses in Healthy Participants
The human brain has a central role in regulating appetite and food intake. It integrates many metabolic, hedonic and trait-related signals that affect eating behaviour and determine when and how much we eat. The effects of non-nutritive sweeteners (NNS) that provide sweet taste with no calories on appetite, food intake thus weight status remain a subject of debate. In this study, the investigators aim to investigate whole brain response to the ingestion of beverages sweetened with caloric sugars (glucose, maltodextrin) or NNS (stevia) as well as neural substrates of attentional bias to food (pre-and post consumption) in healthy lean participants.
Read the detailed description
Non-nutritive sweeteners (NNS) are zero or no calorie alternatives to caloric sugars and their role in appetite and weight status remains inconclusive. NNS similarly as caloric sweeteners activate the oral sweetness receptors and conscious perception of sweetness. However caloric sugars and NNS differ in their metabolic fate after ingestion, so that caloric sugars lead to raised blood glucose, insulin and satiety inducing gut-peptide levels after meals, but NNS do not influence postprandial metabolism. A recently proposed model suggests that metabolic signals may have indirect effects on food reward processing via alterations in higher cognitive function such as attention (Higgs et al. 2017), the role of sweetness in this model is yet to be examined.
In the proposed study stevia-sweetened beverage will be used as the NNS, glucose-sweetened beverage as the caloric sweetener, water as a non-sweet non-caloric control and maltodextrin as a non-sweet caloric control. The study has two aims: first to investigate whole brain responses following the oral consumption of caloric sugars versus NNS using and physiological MRI, and second to examine the neural correlates of the attentional bias to food cues following the consumption of caloric sugars- vs. NNS-sweetened beverages using task-based functional Magnetic Resonance Imaging (fMRI).
In this study participants will be asked to come to the imaging facility on four separate occasions, corresponding to the four study beverages, glucose, stevia, maltodextrin and water. Before coming to an imaging session participants should consume a breakfast of their preference at home (which will be repeated before each session) and then fast for 3-4 hours. Upon arrival subjects will fill in their mood ratings, and the breakfast composition questionnaire and will be ready to start. Firstly, neural responses will be measured (before consumption of the study beverages) while subjects perform a food visual dot probe task (VPT) previously validated to show differences in attentional bias to food between fasted and fed states (Stamataki et al. 2019). Secondly, a physiological MRI measurement will be performed (Little et al. 2013) which will last 40 minutes. Third, subjects will perform again the VPT (after the consumption of the study beverage) whilst an fMRI measurement will be performed.
- Conditions
- Obesity, Sweeteners
- Being tested
- Stevia, Glucose, Maltodextrin, Water
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SteviaDietary supplement
Participants will be administered one of the study beverages at each one of the 4 imaging sessions.
GlucoseDietary supplement
Participants will be administered one of the study beverages at each one of the 4 imaging sessions.
MaltodextrinDietary supplement
Participants will be administered one of the study beverages at each one of the 4 imaging sessions.
WaterDietary supplement
Participants will be administered one of the study beverages at each one of the 4 imaging sessions.
| Study group | Role | What they receive |
|---|---|---|
| Stevia beverage | Experimental | Participants receive 4 study beverages in the 4 imaging sessions in randomised and counterbalanced order. Receives: Dietary Supplement: Stevia |
| Glucose beverage | Experimental | 330 ml of water with glucose (equal sweetness with the stevia beverage) Receives: Dietary Supplement: Glucose |
| Maltodextrin beverage | Experimental | 330 ml of water with maltodextrin (equal amount of calories as the glucose beverage) Receives: Dietary Supplement: Maltodextrin |
| Water | Placebo comparator | 330 ml water Receives: Dietary Supplement: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
physMRI whole brain responses to stevia, glucose and maltodextrin
Participants will undergo a physiological MRI, which will include 10 minutes of baseline (resting), 10 minutes of drinking the solution, and 20 minutes post-consumption (resting).
Measured: -10 minutes to 30 minutes post consumption
fMRI brain response while performing a food visual dot probe task (VPT)
Before and 30 minutes after the consumption of the study beverage, participants will perform a food VPT which is designed to assess attentional bias to food cues while an fMRI will be conducted.
Subjects neural activation when they are responding to congruent trials (dot appearing on the position of a food picture) compared to incongruent trials (dot appearing on the position of a neutral picture).
Measured: 10 minutes (twice)
Secondary outcomes (3)
Attentional bias to food cues (behavioral)
Reaction times to congruent and incongruent trials will be recorded, and an attentional bias to food cues score will be calculated and expressed as the difference pre-and post consumption across the 4 experimental conditions.
Measured: pre- and post (30 minutes) consumption of the study beverage
Appetite ratings
Participant will be asked to rate their subjective appetite (hunger, fullness) at regular intervals during the physMRI. The mean ratings over time, change from baseline as well as area under the curve will be assessed.
Scale includes 0-10 values where 0 is not at all (i.e. not hungry at all) and 10 is extremely (i.e. extremely hungry)
Measured: -10 minutes (before consumption) to 30 minutes post-consumption
Sweetness ratings
Following the consumption of the beverages participants will be asked to rate the sweetness of the beverage they consumed.
Scale includes 0-10 values where 0 is not at all (i.e. not sweet at all) and 10 is extremely (i.e. extremely sweet)
Measured: at 10 minutes postprandially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start14 Nov 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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
- Model description
- Counter-balanced, double-blind, crossover, within-subject design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Cargill
- Responsible party
- Principal investigator, Nikoleta Stamataki, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162457
- Sponsor's protocol ID
- 6814
- Status last verified
- Jul 2021
- First submitted
- 11 Nov 2019
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual Participant Data (IPD) will be shared in an open data repository, provided participants consent.
Publications
Stamataki NS, Elliott R, McKie S, McLaughlin JT. Attentional bias to food varies as a function of metabolic state independent of weight status. Appetite. 2019 Dec 1;143:104388. doi: 10.1016/j.appet.2019.104388. Epub 2019 Jul 31.
PubMed 31376438Little TJ, McKie S, Jones RB, D'Amato M, Smith C, Kiss O, Thompson DG, McLaughlin JT. Mapping glucose-mediated gut-to-brain signalling pathways in humans. Neuroimage. 2014 Aug 1;96:1-11. doi: 10.1016/j.neuroimage.2014.03.059. Epub 2014 Mar 28.
PubMed 24685436
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Caloric and Non-caloric Sweet Preloads on Neural Correlates of Physiological and Neurocognitive Responses in Healthy Participants
- ClinicalTrials.gov ID
- NCT04162457
- Acronym / sponsor ID
- 6814
- Conditions
- Obesity, Sweeteners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Cargill
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 14 Nov 2019 (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 human brain has a central role in regulating appetite and food intake. It integrates many metabolic, hedonic and trait-related signals that affect eating behaviour and determine when and how much we eat. The effects of non-nutritive sweeteners (NNS) that provide sweet taste with no calories on appetite, food intake thus weight status remain a subject of debate. In this study, the investigators aim to investigate whole brain response to the ingestion of beverages sweetened with caloric sugars (glucose, maltodextrin) or NNS (stevia) as well as neural substrates of attentional bias to food (pre-and post consumption) in healthy lean participants.
Detailed description
Non-nutritive sweeteners (NNS) are zero or no calorie alternatives to caloric sugars and their role in appetite and weight status remains inconclusive. NNS similarly as caloric sweeteners activate the oral sweetness receptors and conscious perception of sweetness. However caloric sugars and NNS differ in their metabolic fate after ingestion, so that caloric sugars lead to raised blood glucose, insulin and satiety inducing gut-peptide levels after meals, but NNS do not influence postprandial metabolism. A recently proposed model suggests that metabolic signals may have indirect effects on food reward processing via alterations in higher cognitive function such as attention (Higgs et al. 2017), the role of sweetness in this model is yet to be examined.
In the proposed study stevia-sweetened beverage will be used as the NNS, glucose-sweetened beverage as the caloric sweetener, water as a non-sweet non-caloric control and maltodextrin as a non-sweet caloric control. The study has two aims: first to investigate whole brain responses following the oral consumption of caloric sugars versus NNS using and physiological MRI, and second to examine the neural correlates of the attentional bias to food cues following the consumption of caloric sugars- vs. NNS-sweetened beverages using task-based functional Magnetic Resonance Imaging (fMRI).
In this study participants will be asked to come to the imaging facility on four separate occasions, corresponding to the four study beverages, glucose, stevia, maltodextrin and water. Before coming to an imaging session participants should consume a breakfast of their preference at home (which will be repeated before each session) and then fast for 3-4 hours. Upon arrival subjects will fill in their mood ratings, and the breakfast composition questionnaire and will be ready to start. Firstly, neural responses will be measured (before consumption of the study beverages) while subjects perform a food visual dot probe task (VPT) previously validated to show differences in attentional bias to food between fasted and fed states (Stamataki et al. 2019). Secondly, a physiological MRI measurement will be performed (Little et al. 2013) which will last 40 minutes. Third, subjects will perform again the VPT (after the consumption of the study beverage) whilst an fMRI measurement will be performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Counter-balanced, double-blind, crossover, within-subject design.
| Arm | Type | Receives |
|---|---|---|
| Stevia beverage | Experimental | Dietary Supplement: SteviaParticipants receive 4 study beverages in the 4 imaging sessions in randomised and counterbalanced order. |
| Glucose beverage | Experimental | Dietary Supplement: Glucose330 ml of water with glucose (equal sweetness with the stevia beverage) |
| Maltodextrin beverage | Experimental | Dietary Supplement: Maltodextrin330 ml of water with maltodextrin (equal amount of calories as the glucose beverage) |
| Water | Placebo comparator | Dietary Supplement: Water330 ml water |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Age 18 - 40 years
- BMI between 18.5-25 kg/m2
- Registered to a GP
- Non-restrained eaters, restraint eating score on the Dutch Eating Behaviour Questionnaire (DEBQ) ≤ 3
- Healthy - general good health
Key exclusion criteria (21 listed)
- Habitual NNS consumers, >1 can of diet beverage or >1 table packet of sweeteners per week
- Subjects who have a non-removable metal object in or at their body, such as, for example: heart pace-maker, artificial heart valve, metal prosthesis, implants or splinters, non-removable dental braces
- Tattoos, that are older than 15 years
- Claustrophobia
- Pathological hearing ability or an increased sensitivity to loud noises
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 |
|---|---|---|
| SteviaParticipants will be administered one of the study beverages at each one of the 4 imaging sessions. | Dietary supplement | Stevia beverage |
| GlucoseParticipants will be administered one of the study beverages at each one of the 4 imaging sessions. | Dietary supplement | Glucose beverage |
| MaltodextrinParticipants will be administered one of the study beverages at each one of the 4 imaging sessions. | Dietary supplement | Maltodextrin beverage |
| WaterParticipants will be administered one of the study beverages at each one of the 4 imaging sessions. | Dietary supplement | Water |
Primary outcome
physMRI whole brain responses to stevia, glucose and maltodextrin
Time frame: -10 minutes to 30 minutes post consumption
Participants will undergo a physiological MRI, which will include 10 minutes of baseline (resting), 10 minutes of drinking the solution, and 20 minutes post-consumption (resting).
fMRI brain response while performing a food visual dot probe task (VPT)
Time frame: 10 minutes (twice)
Before and 30 minutes after the consumption of the study beverage, participants will perform a food VPT which is designed to assess attentional bias to food cues while an fMRI will be conducted. Subjects neural activation when they are responding to congruent trials (dot appearing on the position of a food picture) compared to incongruent trials (dot appearing on the position of a neutral picture).
3 secondary outcomes
Attentional bias to food cues (behavioral)
Time frame: pre- and post (30 minutes) consumption of the study beverage
Appetite ratings
Time frame: -10 minutes (before consumption) to 30 minutes post-consumption
Sweetness ratings
Time frame: at 10 minutes postprandially
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 13 Jul 2021.
- Background: PubMed 31376438Stamataki NS, Elliott R, McKie S, McLaughlin JT. Attentional bias to food varies as a function of metabolic state independent of weight status. Appetite. 2019 Dec 1;143:104388. doi: 10.1016/j.appet.2019.104388. Epub 2019 Jul 31.
- Background: PubMed 24685436Little TJ, McKie S, Jones RB, D'Amato M, Smith C, Kiss O, Thompson DG, McLaughlin JT. Mapping glucose-mediated gut-to-brain signalling pathways in humans. Neuroimage. 2014 Aug 1;96:1-11. doi: 10.1016/j.neuroimage.2014.03.059. Epub 2014 Mar 28.
- Individual participant dataSharing planned: Yes. De-identified individual Participant Data (IPD) will be shared in an open data repository, provided participants consent.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stevia, Glucose and Maltodextrin in people with Obesity and Sweeteners, run by University of Manchester at 1 site in United Kingdom.
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 17 inclusion and 21 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 13 Jul 2021. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
physMRI whole brain responses to stevia, glucose and maltodextrin (time frame: -10 minutes to 30 minutes post consumption). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04162457, which also lists 2 linked publications.
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 13 Jul 2021.