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Completed

NCT Number: NCT03202342

fMRI of Hypothalamic Responses to Taste, Temperature and Glucose

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.

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Key information

Conditions

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water

Other

Water, 300 ml, at room temperature

Glucose

Other

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

Ethyl butyrate

Other

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

Glucose + ethyl butyrate

Other

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

Glucose + ethyl butyrate 0 C

Other

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

Primary outcomes

  1. Determine hypothalamic function in response to taste, temperature and glucose sensing

    Time frame: Before (5 minutes) and after (12 minutes) drinking

    BOLD-signal intensity

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Collaborators

  • Leiden University Medical Center

Registry information

Official study title

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

Acronym: COLD-2

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 28, 2017
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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