HealthyNCT03247114
fMRI of Hypothalamic Responses to Glucose, Fructose, Sucrose and Sucralose
A study testing Water, Glucose and Fructose in people with Healthy, run by Unilever R&D at 1 site in Netherlands.
Trial summary
The study will consist of five occasions with one week in between. BOLD signal intensity of the hypothalamus will be measured using fMRI. Measurements will be done before and after drinking 300 ml plain water (reference) or water to which different sweeteners will be added. 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
- Healthy
- What is being tested?
- Water, Glucose and Fructose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Feb 2015to 22 May 2015
- 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 24 kg/m2
- 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 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)
- Smoking (current or last 6 months)
Show all 17Show fewer
- 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: Functional Magnetic Resonance Imaging of Human Hypothalamic Responses to Glucose, Fructose, Sucrose and Sucralose
The study will consist of five occasions with one week in between. BOLD signal intensity of the hypothalamus will be measured using fMRI. Measurements will be done before and after drinking 300 ml plain water (reference) or water to which different sweeteners will be added.
Read the detailed description
The hypothalamus is known to be important for control of feeding behaviour as well as the regulation of temperature. Functional magnetic resonance imaging (fMRI) is a non-invasive method, which detects transient haemodynamic changes in the brain, using blood oxygen level dependent (BOLD) signal differences.
In order to investigate the role of hypothalamic neural activity in response to different sweeteners, fMRI will be performed before, during and after ingestion of 300 ml plain water or 300 ml water containing 50 g glucose, 50 g fructose, 50 g sucrose or 0.33 g sucralose (high intensity sweetener not providing energy). All beverages will be consumed at 22 °C.
The study uses a randomized cross-over design in 16 healthy male subjects with a normal body weight. There will be an interval of at least one week between the five occasions.
Blood Oxygen Level Dependent signal intensity of the hypothalamus will be continuously measured for 21 minutes (5 minutes baseline, 4 minutes during drinking and 12 minutes after drinking).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterOther
Water, 300 ml at room temperature
GlucoseOther
Glucose, 50 grams in 300 ml water at room temperature
FructoseOther
Fructose, 50 grams in 300 ml water at room temperature
SucroseOther
Sucrose, 50 grams in 300 ml water at room temperature
SucraloseOther
Sucralose, 0.33 grams in 300 ml water at room temperature
| Study group | Role | What they receive |
|---|---|---|
| Water-glucose-sucralose-fructose-sucrose | Experimental | First plain water, then glucose, then sucralose, then fructose and then sucrose Receives: Other: Water; Other: Glucose; Other: Fructose; Other: Sucrose; Other: Sucralose |
| water-sucralose-glucose-sucrose-fructose | Experimental | First plain water, then sucralose, then glucose, then sucrose and then fructose Receives: Other: Water; Other: Glucose; Other: Fructose; Other: Sucrose; Other: Sucralose |
| Glucose-water-fructose-sucralose-sucrose | Experimental | First glucose, then plain water, then fructose, then sucralose and then sucrose Receives: Other: Water; Other: Glucose; Other: Fructose; Other: Sucrose; Other: Sucralose |
| Glucose-fructose-water-sucrose-sucralose | Experimental | First glucose, then fructose, then plain water, then sucrose and then sucralose Receives: Other: Water; Other: Glucose; Other: Fructose; Other: Sucrose; Other: Sucralose |
| Fructose-glucose-sucrose-water-sucralose | Experimental | First fructose, then glucose, then sucrose, then plain water and then sucralose Receives: Other: Water; Other: Glucose; Other: Fructose; Other: Sucrose; Other: Sucralose |
| Fructose-sucrose-glucose-sucralose-water | Experimental | First fructose, then sucrose, then glucose, then sucralose and then plain water Receives: Other: Water; Other: Glucose; Other: Fructose; Other: Sucrose; Other: Sucralose |
| Sucrose-fructose-sucralose-glucose-water | Experimental | First sucrose, then fructose, then sucralose, then glucose and then plain water Receives: Other: Water; Other: Glucose; Other: Fructose; Other: Sucrose; Other: Sucralose |
| Sucrose-sucralose-fructose-water-glucose | Experimental | First sucrose, then sucralose, then fructose, then plain water and then glucose Receives: Other: Water; Other: Glucose; Other: Fructose; Other: Sucrose; Other: Sucralose |
| Sucralose-water-sucrose-glucose-fructose | Experimental | First sucralose, then plain water, then sucrose, then glucose and then fructose Receives: Other: Water; Other: Glucose; Other: Fructose; Other: Sucrose; Other: Sucralose |
| Sucralose-sucrose-water-fructose-glucose | Experimental | First sucralose, then sucrose, then plain water, then fructose and then glucose Receives: Other: Water; Other: Glucose; Other: Fructose; Other: Sucrose; Other: Sucralose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothalamic function in response to glucose, fructose, sucrose, and sucralose
fMRI will be performed before and after ingestion
Measured: Change from baseline (measured during 5 minutes before start of dinking) to post consumption (measured during 12 minutes after drinking). Drinking took 4 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start22 Feb 2015
- Primary completion22 May 2015
- Study completion22 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- None (open label)
- Enrolment
- 16 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
- NCT03247114
- Sponsor's protocol ID
- 1930
- Status last verified
- Aug 2017
- First submitted
- 7 Aug 2017
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Opstal AM, Hafkemeijer A, van den Berg-Huysmans AA, Hoeksma M, Blonk C, Pijl H, Rombouts SARB, van der Grond J. Brain activity and connectivity changes in response to glucose ingestion. Nutr Neurosci. 2020 Feb;23(2):110-117. doi: 10.1080/1028415X.2018.1477538. Epub 2018 May 27.
PubMed 29806553
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Magnetic Resonance Imaging of Human Hypothalamic Responses to Glucose, Fructose, Sucrose and Sucralose
- ClinicalTrials.gov ID
- NCT03247114
- Acronym / sponsor ID
- 1930
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Leiden University Medical Center
- Study start
- 22 Feb 2015 (actual)
- Primary completion
- 22 May 2015 (actual)
- Study completion
- 22 May 2015 (actual)
- First posted
- 11 Aug 2017 (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 study will consist of five occasions with one week in between. BOLD signal intensity of the hypothalamus will be measured using fMRI. Measurements will be done before and after drinking 300 ml plain water (reference) or water to which different sweeteners will be added.
Detailed description
The hypothalamus is known to be important for control of feeding behaviour as well as the regulation of temperature. Functional magnetic resonance imaging (fMRI) is a non-invasive method, which detects transient haemodynamic changes in the brain, using blood oxygen level dependent (BOLD) signal differences.
In order to investigate the role of hypothalamic neural activity in response to different sweeteners, fMRI will be performed before, during and after ingestion of 300 ml plain water or 300 ml water containing 50 g glucose, 50 g fructose, 50 g sucrose or 0.33 g sucralose (high intensity sweetener not providing energy). All beverages will be consumed at 22 °C.
The study uses a randomized cross-over design in 16 healthy male subjects with a normal body weight. There will be an interval of at least one week between the five occasions.
Blood Oxygen Level Dependent signal intensity of the hypothalamus will be continuously measured for 21 minutes (5 minutes baseline, 4 minutes during drinking and 12 minutes after drinking).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Water-glucose-sucralose-fructose-sucrose | Experimental | Other: Water, Other: Glucose, Other: Fructose, Other: Sucrose, Other: SucraloseFirst plain water, then glucose, then sucralose, then fructose and then sucrose |
| water-sucralose-glucose-sucrose-fructose | Experimental | Other: Water, Other: Glucose, Other: Fructose, Other: Sucrose, Other: SucraloseFirst plain water, then sucralose, then glucose, then sucrose and then fructose |
| Glucose-water-fructose-sucralose-sucrose | Experimental | Other: Water, Other: Glucose, Other: Fructose, Other: Sucrose, Other: SucraloseFirst glucose, then plain water, then fructose, then sucralose and then sucrose |
| Glucose-fructose-water-sucrose-sucralose | Experimental | Other: Water, Other: Glucose, Other: Fructose, Other: Sucrose, Other: SucraloseFirst glucose, then fructose, then plain water, then sucrose and then sucralose |
| Fructose-glucose-sucrose-water-sucralose | Experimental | Other: Water, Other: Glucose, Other: Fructose, Other: Sucrose, Other: SucraloseFirst fructose, then glucose, then sucrose, then plain water and then sucralose |
| Fructose-sucrose-glucose-sucralose-water | Experimental | Other: Water, Other: Glucose, Other: Fructose, Other: Sucrose, Other: SucraloseFirst fructose, then sucrose, then glucose, then sucralose and then plain water |
| Sucrose-fructose-sucralose-glucose-water | Experimental | Other: Water, Other: Glucose, Other: Fructose, Other: Sucrose, Other: SucraloseFirst sucrose, then fructose, then sucralose, then glucose and then plain water |
| Sucrose-sucralose-fructose-water-glucose | Experimental | Other: Water, Other: Glucose, Other: Fructose, Other: Sucrose, Other: SucraloseFirst sucrose, then sucralose, then fructose, then plain water and then glucose |
| Sucralose-water-sucrose-glucose-fructose | Experimental | Other: Water, Other: Glucose, Other: Fructose, Other: Sucrose, Other: SucraloseFirst sucralose, then plain water, then sucrose, then glucose and then fructose |
| Sucralose-sucrose-water-fructose-glucose | Experimental | Other: Water, Other: Glucose, Other: Fructose, Other: Sucrose, Other: SucraloseFirst sucralose, then sucrose, then plain water, then fructose and then glucose |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Age between 18 and 25 years
- BMI between 20 and 24 kg/m2
- Length between 170 and 190 centimetres
Key exclusion criteria (17 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 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)
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 |
|---|---|---|
| WaterWater, 300 ml at room temperature | Other | Fructose-glucose-sucrose-water-sucralose, Fructose-sucrose-glucose-sucralose-water, Glucose-fructose-water-sucrose-sucralose, Glucose-water-fructose-sucralose-sucrose, Sucralose-sucrose-water-fructose-glucose, Sucralose-water-sucrose-glucose-fructose, Sucrose-fructose-sucralose-glucose-water, Sucrose-sucralose-fructose-water-glucose, Water-glucose-sucralose-fructose-sucrose, water-sucralose-glucose-sucrose-fructose |
| GlucoseGlucose, 50 grams in 300 ml water at room temperature | Other | Fructose-glucose-sucrose-water-sucralose, Fructose-sucrose-glucose-sucralose-water, Glucose-fructose-water-sucrose-sucralose, Glucose-water-fructose-sucralose-sucrose, Sucralose-sucrose-water-fructose-glucose, Sucralose-water-sucrose-glucose-fructose, Sucrose-fructose-sucralose-glucose-water, Sucrose-sucralose-fructose-water-glucose, Water-glucose-sucralose-fructose-sucrose, water-sucralose-glucose-sucrose-fructose |
| FructoseFructose, 50 grams in 300 ml water at room temperature | Other | Fructose-glucose-sucrose-water-sucralose, Fructose-sucrose-glucose-sucralose-water, Glucose-fructose-water-sucrose-sucralose, Glucose-water-fructose-sucralose-sucrose, Sucralose-sucrose-water-fructose-glucose, Sucralose-water-sucrose-glucose-fructose, Sucrose-fructose-sucralose-glucose-water, Sucrose-sucralose-fructose-water-glucose, Water-glucose-sucralose-fructose-sucrose, water-sucralose-glucose-sucrose-fructose |
| SucroseSucrose, 50 grams in 300 ml water at room temperature | Other | Fructose-glucose-sucrose-water-sucralose, Fructose-sucrose-glucose-sucralose-water, Glucose-fructose-water-sucrose-sucralose, Glucose-water-fructose-sucralose-sucrose, Sucralose-sucrose-water-fructose-glucose, Sucralose-water-sucrose-glucose-fructose, Sucrose-fructose-sucralose-glucose-water, Sucrose-sucralose-fructose-water-glucose, Water-glucose-sucralose-fructose-sucrose, water-sucralose-glucose-sucrose-fructose |
| SucraloseSucralose, 0.33 grams in 300 ml water at room temperature | Other | Fructose-glucose-sucrose-water-sucralose, Fructose-sucrose-glucose-sucralose-water, Glucose-fructose-water-sucrose-sucralose, Glucose-water-fructose-sucralose-sucrose, Sucralose-sucrose-water-fructose-glucose, Sucralose-water-sucrose-glucose-fructose, Sucrose-fructose-sucralose-glucose-water, Sucrose-sucralose-fructose-water-glucose, Water-glucose-sucralose-fructose-sucrose, water-sucralose-glucose-sucrose-fructose |
Primary outcome
Hypothalamic function in response to glucose, fructose, sucrose, and sucralose
Time frame: Change from baseline (measured during 5 minutes before start of dinking) to post consumption (measured during 12 minutes after drinking). Drinking took 4 minutes.
fMRI will be performed before and after ingestion
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 11 Aug 2017.
- Derived from this study: PubMed 29806553van Opstal AM, Hafkemeijer A, van den Berg-Huysmans AA, Hoeksma M, Blonk C, Pijl H, Rombouts SARB, van der Grond J. Brain activity and connectivity changes in response to glucose ingestion. Nutr Neurosci. 2020 Feb;23(2):110-117. doi: 10.1080/1028415X.2018.1477538. Epub 2018 May 27.
- 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 Water, Glucose and Fructose in people with Healthy, 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 4 inclusion and 17 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 11 Aug 2017. 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?
Hypothalamic function in response to glucose, fructose, sucrose, and sucralose (time frame: Change from baseline (measured during 5 minutes before start of dinking) to post consumption (measured during 12 minutes after drinking). Drinking took 4 minutes.). 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 NCT03247114, which also lists 1 linked publication.
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 11 Aug 2017.