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fMRI of Hypothalamic Responses to Taste, Temperature and Glucose

Functional Magnetic Resonance Imaging of Human Hypothalamic Responses to Taste, Temperature and Glucose Sensing

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03202342
Acronym
COLD-2
Enrollment
16
Registered
2017-06-28
Start date
2013-11-11
Completion date
2014-10-30
Last updated
2017-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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 or water to which glucose and/or ethyl butyrate 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 taste, glucose and temperature, fMRI will be performed before, during and after ingestion of 300 ml plain water or water with added ethyl butyrate (pineapple flavour), added glucose or added ethyl butyrate plus glucose. All beverages will be consumed at 22 °C and the combination will also be drunk at 0 °C. The study uses a randomised 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. BOLD signal intensity of the hypothalamus will be continuously measured for 21 minutes (5 minutes baseline, 4 minutes during drinking and 12 minutes after drinking).

Interventions

OTHERWater

Water, 300 ml, at room temperature

OTHERGlucose

Water containing 50 g glucose, 300 ml, at room temperature

OTHEREthyl butyrate

Water containing ethyl butyrate (pineapple flavour) 300 ml, at room temperature

OTHERGlucose + ethyl butyrate

Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at room temperature

OTHERGlucose + ethyl butyrate 0 C

Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at 0 degrees centigrade

Sponsors

Leiden University Medical Center
CollaboratorOTHER
Unilever R&D
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

* Signed informed consent * Age between 18 and 25 years * BMI between 20 and 23 kg/m2 * Length between 170 and 190 centimetres

Exclusion criteria

* 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) * 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

Design outcomes

Primary

MeasureTime frameDescription
Determine hypothalamic function in response to taste, temperature and glucose sensingBefore (5 minutes) and after (12 minutes) drinkingBOLD-signal intensity

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026