fMRI of Hypothalamic Responses to Taste, Temperature and Glucose

Healthy Clinical Trial

— COLD-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202342
• Other study ID #: 1302
• Status: Completed
• Phase: N/A
• First received: June 26, 2017
• Last updated: June 26, 2017
• Start date: November 11, 2013
• Est. completion date: October 30, 2014

Study information

• Verified date: June 2017
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 or water to which glucose and/or ethyl butyrate will be added.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 30, 2014
• Est. primary completion date: October 30, 2014
• 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 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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Water
Water, 300 ml, at room temperature
• Glucose
Water containing 50 g glucose, 300 ml, at room temperature
• Ethyl butyrate
Water containing ethyl butyrate (pineapple flavour) 300 ml, at room temperature
• Glucose + ethyl butyrate
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at room temperature
• Glucose + ethyl butyrate 0 C
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at 0 degrees centigrade

Locations

Country	Name	City	State
Netherlands	Leids Universitair Medisch Centrum	Leiden	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Unilever R&D	Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine hypothalamic function in response to taste, temperature and glucose sensing	BOLD-signal intensity	Before (5 minutes) and after (12 minutes) drinking