HealthyCOLDNCT03181217
Functional Magnetic Resonance Imaging of Human Hypothalamic Responses to Oral Temperature and Glucose Sensing
A study testing water 0, water 22 and Glucose 0 in people with Healthy, run by Unilever R&D at 1 site in Netherlands.
Trial summary
The study will consist of four occasions with one week between the occasions. fMRI will be performed to monitor hypothalamic activity before and after an ingestion of 1 of the following 4 stimuli (300 ml of each): water at room temperature, water at 0 degrees Celsius, glucose solution at room temperature, glucose… 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 0, water 22 and Glucose 0
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Jan 2013to 23 May 2013
- 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
- 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 loose weight (> 3 kg weight gain or loss, within the last 3 months)
- Smoking (current or last 6 months)
Show all 9Show 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 2 or more biomedical research projects in one year
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leids Universitair Medisch Centrum
Leiden, South Holland
About this study
The study will consist of four occasions with one week between the occasions. fMRI will be performed to monitor hypothalamic activity before and after an ingestion of 1 of the following 4 stimuli (300 ml of each): water at room temperature, water at 0 degrees Celsius, glucose solution at room temperature, glucose solution at 0 degrees Celsius. The last two stimuli both contain 75 gram glucose. The order of conditions will be randomly assigned to the subjects. Functional connectivity of the hypothalamic regions will be assessed by analysing the resting state fMRI.
Read the detailed description
Background of the study: Thermo-regulation is an important aspect of human homeostasis. A decrease in brain and/or body temperature will increase energy requirements and eventually food intake, which acts as a defence against hypothermia. The hypothalamus plays a central role in the regulation of temperature as well as in the control of energy intake, feeding behaviour and lipid and glucose metabolism. The effect of both cooling and changes in energy demand, will therefore be reflected in hypothalamic activity.
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 response to external or internal stimuli. Recently, several fMRI studies have shown the feasibility of measuring hypothalamic function in response to glucose ingestion.
In order to investigate the role of hypothalamic neural activity in response to cooling by food temperature and the additional effect of glucose concentration, fMRI will be performed in healthy men after ingestion of one of 4 solutions at different temperatures and with different glucose concentration.
The study will consist of four occasions. There will be an interval of at least one week between the occasions. On all occasions, the subject will be admitted to the Clinical Research Unit of the LUMC. After a acclimatisation period of 30 minutes and anthropometric measurements (weight and height), fMRI to monitor hypothalamic activity will be performed after an ingestion of 1 of the following 4 stimuli (300 ml of each): water at room temperature, water almost frozen (0 C), glucose solution at room temperature, almost frozen glucose solution (0 C). The last two stimuli both contain 75 gram glucose. Conditions will be randomly assigned to the subjects, a batch wise randomisation procedure will be followed. The order of allocation of each subject is recorded on paper and stored in a sealed envelop, which will be opened after inclusion in the study. The hypothalamus will be continuously imaged for 20 min. (8 min baseline, 4 min drinking, 8 min post ingestion) using a conventional T2*-weighted gradient-echo pulse sequence. A resting state fMRI will be carried out before and after the fMRI of the hypothalamic activity. Hedonic changes or reward effects of the administration will be captured by separate analysis of the amygdala and nucleus accumbens in each subject.
- Conditions
- Healthy
- Being tested
- water 0, water 22, Glucose 0, Glucose 22
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water 0Other
300 ml tap water at 0 ºC
water 22Other
300 ml tap water at 22 ºC
Glucose 0Other
300 ml tap water at 0 ºC with 75 grams of glucose added
Glucose 22Other
300 ml tap water at 22 ºC with 75 grams of glucose added
| Study group | Role | What they receive |
|---|---|---|
| water 22, water 0, glucose 0, glucose 22 | Experimental | Subjects consume 300 ml water at 22 ºC, 300 ml water at 0 ºC, 300 ml water at 0 ºC containing 75 grams glucose and 300 ml water at 22 ºC containing 75 grams glucose sequentially with a one-week washout between consumptions Receives: Other: water 0; Other: water 22; Other: Glucose 0; Other: Glucose 22 |
| water 0, glucose 22, water 22, glucose 0 | Experimental | Subjects consume 300 ml water at 0 ºC, 300 ml water at 22 ºC containing 75 grams glucose, 300 ml water at 22 ºC and 300 ml water at 0 ºC containing 75 grams glucose sequentially with a one-week washout between consumptions Receives: Other: water 0; Other: water 22; Other: Glucose 0; Other: Glucose 22 |
| glucose 22, glucose 0, water 0, water 22 | Experimental | Subjects consume 300 ml water at 22ºC containing 75 grams glucose, 300 ml water at 0 ºC containing 75 grams glucose, 300 ml water at 0 ºC and 300 ml water at 22 ºC sequentially with a one-week washout between consumptions Receives: Other: water 0; Other: water 22; Other: Glucose 0; Other: Glucose 22 |
| glucose 0, water 22, glucose 22, water 0 | Experimental | Subjects consume 300 ml water at 0 ºC containing 75 grams glucose, 300 ml water at 22 ºC, 300 ml water at 22 ºC containing 75 grams glucose and 300 ml water at 0 ºC sequentially with a one-week washout between consumptions Receives: Other: water 0; Other: water 22; Other: Glucose 0; Other: Glucose 22 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional magnetic resonance imaging of the hypothalamus
Hypothalamic neural activity measured using Blood Oxygen Level Dependent signal measured by functional magnetic resonance imaging
Measured: fMRI measurements between 8 and 20 minutes after start of beverage intake
Secondary outcomes (2)
Functional magnetic resonance imaging of the amygdala
Neural activity in the amygdala measured using Blood Oxygen Level Dependent signal
Measured: fMRI measurements between 8 and 20 minutes after start of beverage intake
Functional magnetic resonance imaging of the nucleus accumbens
Neural activity in the nucleus accumbens measured using Blood Oxygen Level Dependent signal
Measured: fMRI measurements between 8 and 20 minutes after start of beverage intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start28 Jan 2013
- Primary completion23 May 2013
- Study completion23 May 2013
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
- Single blind
- Who is masked
- Outcomes assessor
- 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, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181217
- Sponsor's protocol ID
- FDS-BNH-0770
- Acronym
- COLD
- Status last verified
- Jun 2017
- First submitted
- 6 Jun 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Opstal AM, van den Berg-Huysmans AA, Hoeksma M, Blonk C, Pijl H, Rombouts SARB, van der Grond J. The effect of consumption temperature on the homeostatic and hedonic responses to glucose ingestion in the hypothalamus and the reward system. Am J Clin Nutr. 2018 Jan 1;107(1):20-25. doi: 10.1093/ajcn/nqx023.
PubMed 29381802
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 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 Oral Temperature and Glucose Sensing
- ClinicalTrials.gov ID
- NCT03181217
- Acronym / sponsor ID
- COLD / FDS-BNH-0770
- 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
- 28 Jan 2013 (actual)
- Primary completion
- 23 May 2013 (actual)
- Study completion
- 23 May 2013 (actual)
- First posted
- 8 Jun 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 four occasions with one week between the occasions. fMRI will be performed to monitor hypothalamic activity before and after an ingestion of 1 of the following 4 stimuli (300 ml of each): water at room temperature, water at 0 degrees Celsius, glucose solution at room temperature, glucose solution at 0 degrees Celsius. The last two stimuli both contain 75 gram glucose. The order of conditions will be randomly assigned to the subjects. Functional connectivity of the hypothalamic regions will be assessed by analysing the resting state fMRI.
Detailed description
Background of the study: Thermo-regulation is an important aspect of human homeostasis. A decrease in brain and/or body temperature will increase energy requirements and eventually food intake, which acts as a defence against hypothermia. The hypothalamus plays a central role in the regulation of temperature as well as in the control of energy intake, feeding behaviour and lipid and glucose metabolism. The effect of both cooling and changes in energy demand, will therefore be reflected in hypothalamic activity.
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 response to external or internal stimuli. Recently, several fMRI studies have shown the feasibility of measuring hypothalamic function in response to glucose ingestion.
In order to investigate the role of hypothalamic neural activity in response to cooling by food temperature and the additional effect of glucose concentration, fMRI will be performed in healthy men after ingestion of one of 4 solutions at different temperatures and with different glucose concentration.
The study will consist of four occasions. There will be an interval of at least one week between the occasions. On all occasions, the subject will be admitted to the Clinical Research Unit of the LUMC. After a acclimatisation period of 30 minutes and anthropometric measurements (weight and height), fMRI to monitor hypothalamic activity will be performed after an ingestion of 1 of the following 4 stimuli (300 ml of each): water at room temperature, water almost frozen (0 C), glucose solution at room temperature, almost frozen glucose solution (0 C). The last two stimuli both contain 75 gram glucose. Conditions will be randomly assigned to the subjects, a batch wise randomisation procedure will be followed. The order of allocation of each subject is recorded on paper and stored in a sealed envelop, which will be opened after inclusion in the study. The hypothalamus will be continuously imaged for 20 min. (8 min baseline, 4 min drinking, 8 min post ingestion) using a conventional T2*-weighted gradient-echo pulse sequence. A resting state fMRI will be carried out before and after the fMRI of the hypothalamic activity. Hedonic changes or reward effects of the administration will be captured by separate analysis of the amygdala and nucleus accumbens in each subject.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| water 22, water 0, glucose 0, glucose 22 | Experimental | Other: water 0, Other: water 22, Other: Glucose 0, Other: Glucose 22Subjects consume 300 ml water at 22 ºC, 300 ml water at 0 ºC, 300 ml water at 0 ºC containing 75 grams glucose and 300 ml water at 22 ºC containing 75 grams glucose sequentially with a one-week washout between consumptions |
| water 0, glucose 22, water 22, glucose 0 | Experimental | Other: water 0, Other: water 22, Other: Glucose 0, Other: Glucose 22Subjects consume 300 ml water at 0 ºC, 300 ml water at 22 ºC containing 75 grams glucose, 300 ml water at 22 ºC and 300 ml water at 0 ºC containing 75 grams glucose sequentially with a one-week washout between consumptions |
| glucose 22, glucose 0, water 0, water 22 | Experimental | Other: water 0, Other: water 22, Other: Glucose 0, Other: Glucose 22Subjects consume 300 ml water at 22ºC containing 75 grams glucose, 300 ml water at 0 ºC containing 75 grams glucose, 300 ml water at 0 ºC and 300 ml water at 22 ºC sequentially with a one-week washout between consumptions |
| glucose 0, water 22, glucose 22, water 0 | Experimental | Other: water 0, Other: water 22, Other: Glucose 0, Other: Glucose 22Subjects consume 300 ml water at 0 ºC containing 75 grams glucose, 300 ml water at 22 ºC, 300 ml water at 22 ºC containing 75 grams glucose and 300 ml water at 0 ºC sequentially with a one-week washout between consumptions |
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 23 kg/m2
- Length between 170 and 190 centimetres
Key exclusion criteria (9 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 loose 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 |
|---|---|---|
| water 0300 ml tap water at 0 ºC | Other | glucose 0, water 22, glucose 22, water 0, glucose 22, glucose 0, water 0, water 22, water 0, glucose 22, water 22, glucose 0, water 22, water 0, glucose 0, glucose 22 |
| water 22300 ml tap water at 22 ºC | Other | glucose 0, water 22, glucose 22, water 0, glucose 22, glucose 0, water 0, water 22, water 0, glucose 22, water 22, glucose 0, water 22, water 0, glucose 0, glucose 22 |
| Glucose 0300 ml tap water at 0 ºC with 75 grams of glucose added | Other | glucose 0, water 22, glucose 22, water 0, glucose 22, glucose 0, water 0, water 22, water 0, glucose 22, water 22, glucose 0, water 22, water 0, glucose 0, glucose 22 |
| Glucose 22300 ml tap water at 22 ºC with 75 grams of glucose added | Other | glucose 0, water 22, glucose 22, water 0, glucose 22, glucose 0, water 0, water 22, water 0, glucose 22, water 22, glucose 0, water 22, water 0, glucose 0, glucose 22 |
Primary outcome
Functional magnetic resonance imaging of the hypothalamus
Time frame: fMRI measurements between 8 and 20 minutes after start of beverage intake
Hypothalamic neural activity measured using Blood Oxygen Level Dependent signal measured by functional magnetic resonance imaging
2 secondary outcomes
Functional magnetic resonance imaging of the amygdala
Time frame: fMRI measurements between 8 and 20 minutes after start of beverage intake
Functional magnetic resonance imaging of the nucleus accumbens
Time frame: fMRI measurements between 8 and 20 minutes after start of beverage 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 9 Jun 2017.
- Derived from this study: PubMed 29381802van Opstal AM, van den Berg-Huysmans AA, Hoeksma M, Blonk C, Pijl H, Rombouts SARB, van der Grond J. The effect of consumption temperature on the homeostatic and hedonic responses to glucose ingestion in the hypothalamus and the reward system. Am J Clin Nutr. 2018 Jan 1;107(1):20-25. doi: 10.1093/ajcn/nqx023.
- 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 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 0, water 22 and Glucose 0 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 9 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 9 Jun 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?
Functional magnetic resonance imaging of the hypothalamus (time frame: fMRI measurements between 8 and 20 minutes after start of beverage 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 NCT03181217, 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 9 Jun 2017.