PleasureNCT02745730
RS-fMRI to Nutrient Shakes
A study testing Glucose, Fructose and Sucralose in people with Pleasure, run by Unilever R&D at 1 site in Netherlands.
Trial summary
Resting state functional magnetic resonance imaging (rsfMRl) of the brain is used to measure pleasantness after consumption of four different milkshakes with added sugars or sweeteners. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pleasure
- What is being tested?
- Glucose, Fructose and Sucralose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2016to Oct 2016
- 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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent
- Age between 18 and 25 years
- BMI between 20 and 23 kg/m2
- Weight above 70 kg
- Length between 170 and 190 centimetres
Who cannot join
- Diabetes or history of other disturbances of glucose metabolism (eg impaired glucose tolerance, hypoglycaemia).
- Any genetic or psychiatric disease (e.g. fragile X syndrome, major depression) affecting brain
- Any know food allergy or intolerance
- Any significant chronic disease
- Renal or hepatic disease
- Recent weight changes or attempts to lose weight (> 3 kg weight gain or loss, within the last 3 months)
Show all 18Show fewer
- Smoking (current or last 6 months)
- Alcohol consumption of more than 21 units per week or use of recreational drugs at present or in the last year
- Recent blood donation (within the last 2 months)
- Recent participation in other biomedical research projects (within the last 3 months), participation in 3 or more biomedical research projects in one year
- Contra-indication to MRI scanning:
- Claustrophobia
- Pacemakers and defibrillators
- Nerve stimulators
- Intracranial clips
- intraorbital or intraocular metallic fragments
- Cochlear implants
- Ferromagnetic implants
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leids Universitair Medisch Centrum
Leiden, South Holland
About this study
Official title: Resting State Functional Magnetic Resonance Imaging of Human Brain Responses to Nutrient Shake
Resting state functional magnetic resonance imaging (rsfMRl) of the brain is used to measure pleasantness after consumption of four different milkshakes with added sugars or sweeteners.
Read the detailed description
The central role of the brain in regulating food intake and steering feeding behaviour is increasingly recognized. It is currently well accepted that the brain is the target organ to measure the effects of pleasantness and energy homeostasis in order to change feeding behaviour to reduce the rising prevalence of obesity. The effects of food on the brain are multiple and complex. In addition to primary aspects of food such as taste, texture, looks and smell, secondary aspects such as energy regulation are as much important in the entire "eating experience". Resting state functional connectivity in the brain can be assessed by the analysis of low-frequency fluctuations present in the blood-oxygenation-level-dependent (BOLD) signal in functional magnetic resonance imaging (fMRI). Investigators will use resting state functional magnetic resonance imaging (rsfMRl) to detect changes in connectivity in the default mode and salience network after consumption of four different milkshakes with added sugars or sweeteners.
- Conditions
- Pleasure
- Being tested
- Glucose, Fructose, Sucralose, Allulose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoseOther
FructoseOther
SucraloseOther
AlluloseOther
| Study group | Role | What they receive |
|---|---|---|
| Glucose | Active comparator | Shake sweetened with glucose Receives: Other: Glucose |
| Fructose | Active comparator | Shake sweetened with fructose Receives: Other: Fructose |
| Sucralose | Experimental | Shake sweetened with sucralose Receives: Other: Sucralose |
| Allulose | Experimental | Shake sweetened with allulose Receives: Other: Allulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the connectivity in the default mode and salience network: glucose and fructose vs. sucralose and allulose.
Measured: Six minutes before (baseline) and 12 minutes after (response) test product intake
Secondary outcomes (2)
2. Change from baseline in the connectivity in the default mode and salience network: glucose vs. fructose.
Measured: Six minutes before (baseline) and 12 minutes after (response) test product intake
3. Change from baseline in the connectivity in the default mode and salience network: allulose vs. sucralose.
Measured: Six minutes before (baseline) and 12 minutes after (response) test product intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2016
- Study completionOct 2016
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 PleasureStudies of the same condition, open and under way.
- 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
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Leiden University Medical Center
- Responsible party
- Sponsor
- Investigators
- Jeroen van der Grond, Dr., Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745730
- Sponsor's protocol ID
- REF-ICE-2421
- Status last verified
- Nov 2016
- First submitted
- 4 Apr 2016
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lodi A, Zarantonello L, Bisiacchi PS, Cenci L, Paoli A. Ketonemia and Glycemia Affect Appetite Levels and Executive Functions in Overweight Females During Two Ketogenic Diets. Obesity (Silver Spring). 2020 Oct;28(10):1868-1877. doi: 10.1002/oby.22934. Epub 2020 Sep 1.
PubMed 32875733Van Opstal AM, Hafkemeijer A, van den Berg-Huysmans AA, Hoeksma M, Mulder TPJ, Pijl H, Rombouts SARB, van der Grond J. Brain activity and connectivity changes in response to nutritive natural sugars, non-nutritive natural sugar replacements and artificial sweeteners. Nutr Neurosci. 2021 May;24(5):395-405. doi: 10.1080/1028415X.2019.1639306. Epub 2019 Jul 10.
PubMed 31288630
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting State Functional Magnetic Resonance Imaging of Human Brain Responses to Nutrient Shake
- ClinicalTrials.gov ID
- NCT02745730
- Acronym / sponsor ID
- REF-ICE-2421
- Conditions
- Pleasure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Leiden University Medical Center
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 20 Apr 2016 (estimated)
- 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.
Resting state functional magnetic resonance imaging (rsfMRl) of the brain is used to measure pleasantness after consumption of four different milkshakes with added sugars or sweeteners.
Detailed description
The central role of the brain in regulating food intake and steering feeding behaviour is increasingly recognized. It is currently well accepted that the brain is the target organ to measure the effects of pleasantness and energy homeostasis in order to change feeding behaviour to reduce the rising prevalence of obesity. The effects of food on the brain are multiple and complex. In addition to primary aspects of food such as taste, texture, looks and smell, secondary aspects such as energy regulation are as much important in the entire "eating experience". Resting state functional connectivity in the brain can be assessed by the analysis of low-frequency fluctuations present in the blood-oxygenation-level-dependent (BOLD) signal in functional magnetic resonance imaging (fMRI). Investigators will use resting state functional magnetic resonance imaging (rsfMRl) to detect changes in connectivity in the default mode and salience network after consumption of four different milkshakes with added sugars or sweeteners.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Glucose | Active comparator | Other: GlucoseShake sweetened with glucose |
| Fructose | Active comparator | Other: FructoseShake sweetened with fructose |
| Sucralose | Experimental | Other: SucraloseShake sweetened with sucralose |
| Allulose | Experimental | Other: AlluloseShake sweetened with allulose |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Age between 18 and 25 years
- BMI between 20 and 23 kg/m2
- Weight above 70 kg
- Length between 170 and 190 centimetres
Key exclusion criteria (18 listed)
- Diabetes or history of other disturbances of glucose metabolism (eg impaired glucose tolerance, hypoglycaemia).
- Any genetic or psychiatric disease (e.g. fragile X syndrome, major depression) affecting brain
- Any know food allergy or intolerance
- Any significant chronic disease
- Renal or hepatic disease
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 |
|---|---|---|
| Glucose | Other | Glucose |
| Fructose | Other | Fructose |
| Sucralose | Other | Sucralose |
| Allulose | Other | Allulose |
Primary outcome
Change from baseline in the connectivity in the default mode and salience network: glucose and fructose vs. sucralose and allulose.
Time frame: Six minutes before (baseline) and 12 minutes after (response) test product intake
2 secondary outcomes
2. Change from baseline in the connectivity in the default mode and salience network: glucose vs. fructose.
Time frame: Six minutes before (baseline) and 12 minutes after (response) test product intake
3. Change from baseline in the connectivity in the default mode and salience network: allulose vs. sucralose.
Time frame: Six minutes before (baseline) and 12 minutes after (response) test product intake
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 21 Nov 2016.
- Derived from this study: PubMed 32875733Lodi A, Zarantonello L, Bisiacchi PS, Cenci L, Paoli A. Ketonemia and Glycemia Affect Appetite Levels and Executive Functions in Overweight Females During Two Ketogenic Diets. Obesity (Silver Spring). 2020 Oct;28(10):1868-1877. doi: 10.1002/oby.22934. Epub 2020 Sep 1.
- Derived from this study: PubMed 31288630Van Opstal AM, Hafkemeijer A, van den Berg-Huysmans AA, Hoeksma M, Mulder TPJ, Pijl H, Rombouts SARB, van der Grond J. Brain activity and connectivity changes in response to nutritive natural sugars, non-nutritive natural sugar replacements and artificial sweeteners. Nutr Neurosci. 2021 May;24(5):395-405. doi: 10.1080/1028415X.2019.1639306. Epub 2019 Jul 10.
- 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.
Jeroen van der Grond, Dr. principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose, Fructose and Sucralose in people with Pleasure, run by Unilever R&D at 1 site in Netherlands.
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 18 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 21 Nov 2016. 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 Netherlands. 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?
Change from baseline in the connectivity in the default mode and salience network: glucose and fructose vs. sucralose and allulose. (time frame: Six minutes before (baseline) and 12 minutes after (response) test product intake). 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 NCT02745730, 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 21 Nov 2016.