Healthy Clinical Trial
— COLDOfficial title:
Functional Magnetic Resonance Imaging of Human Hypothalamic Responses to Oral Temperature and Glucose Sensing
Verified date | June 2017 |
Source | Unilever R&D |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | May 23, 2013 |
Est. primary completion date | May 23, 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 25 Years |
Eligibility |
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 loose 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 2 or more biomedical research projects in one year |
Country | Name | City | State |
---|---|---|---|
Netherlands | Leids Universitair Medisch Centrum | Leiden | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Unilever R&D | Leiden University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional magnetic resonance imaging of the hypothalamus | Hypothalamic neural activity measured using Blood Oxygen Level Dependent signal measured by functional magnetic resonance imaging | fMRI measurements between 8 and 20 minutes after start of beverage intake | |
Secondary | Functional magnetic resonance imaging of the amygdala | Neural activity in the amygdala measured using Blood Oxygen Level Dependent signal | fMRI measurements between 8 and 20 minutes after start of beverage intake | |
Secondary | Functional magnetic resonance imaging of the nucleus accumbens | Neural activity in the nucleus accumbens measured using Blood Oxygen Level Dependent signal | fMRI measurements between 8 and 20 minutes after start of beverage intake |
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