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fMRI of Hypothalamic Responses to Taste, Temperature and Glucose (COLD-2)

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Unilever

Status

Completed

Conditions

Healthy

Treatments

Other: Ethyl butyrate
Other: Glucose + ethyl butyrate
Other: Glucose
Other: Glucose + ethyl butyrate 0 C
Other: Water

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03202342
1302

Details and patient eligibility

About

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.

Full 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).

Read more

Enrollment

16 patients

Sex

Male

Ages

18 to 25 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

16 participants in 10 patient groups

Water/gluc/gluc+EB/EB/gluc+EB_cold
Experimental group
Description:
First Water 22 C, then Glucose 22 C, then Glucose + Ethyl butyrate 22 C, then Ethyl butyrate 22 C and then Glucose + Ethyl butyrate 0 C
Treatment:
Other: Glucose + ethyl butyrate
Other: Ethyl butyrate
Other: Glucose
Other: Glucose + ethyl butyrate 0 C
Other: Water
Water/gluc+EB/gluc/gluc+EB_cold/EB
Experimental group
Description:
First Water 22 C, then Glucose + Ethyl butyrate 22 C, then Glucose 22 C, then Glucose + Ethyl butyrate 0 C and then Ethyl butyrate 22 C
Treatment:
Other: Glucose + ethyl butyrate
Other: Ethyl butyrate
Other: Glucose
Other: Glucose + ethyl butyrate 0 C
Other: Water
Gluc/water/EB/gluc+EB/glucose+EB_cold
Experimental group
Description:
First Glucose 22 C, then Water 22 C, then Ethyl butyrate 22 C, then Glucose + Ethyl butyrate 22 C and then Glucose + Ethyl butyrate 0 C
Treatment:
Other: Glucose + ethyl butyrate
Other: Ethyl butyrate
Other: Glucose
Other: Glucose + ethyl butyrate 0 C
Other: Water
Gluc/EB/water/gluc+EB_cold/gluc+EB
Experimental group
Description:
First Glucose 22 C, then Ethyl butyrate 22 C, then Water 22 C, then Glucose + Ethyl butyrate 0 C and then Glucose + Ethyl butyrate 22 C
Treatment:
Other: Glucose + ethyl butyrate
Other: Ethyl butyrate
Other: Glucose
Other: Glucose + ethyl butyrate 0 C
Other: Water
EB/Gluc/gluc+EB_cold/water/glucose+EB
Experimental group
Description:
First Ethyl butyrate 22 C, then Glucose 22 C, then Glucose + Ethyl butyrate 0 C, then Water 22 C and then Glucose + Ethyl butyrate 22 C
Treatment:
Other: Glucose + ethyl butyrate
Other: Ethyl butyrate
Other: Glucose
Other: Glucose + ethyl butyrate 0 C
Other: Water
EB/gluc+EB_cold/gluc/glucose+EB/water
Experimental group
Description:
First Ethyl butyrate 22 C, then Glucose + Ethyl butyrate 0 C, then Glucose 22 C, then Glucose + Ethyl butyrate 22 C and then Water 22 C
Treatment:
Other: Glucose + ethyl butyrate
Other: Ethyl butyrate
Other: Glucose
Other: Glucose + ethyl butyrate 0 C
Other: Water
Gluc+EB_cold/water/glucose+EB/glucose/EB
Experimental group
Description:
First Glucose + Ethyl butyrate 22 C, then Water 22 C, then Glucose + Ethyl butyrate 0 C, then Glucose 22 C and then Ethyl butyrate 22 C
Treatment:
Other: Glucose + ethyl butyrate
Other: Ethyl butyrate
Other: Glucose
Other: Glucose + ethyl butyrate 0 C
Other: Water
Gluc+EB_cold/glucose+EB/water/EB/glucose
Experimental group
Description:
First Glucose + Ethyl butyrate 22 C, then Glucose + Ethyl butyrate 0 C, then Water 22 C, then Ethyl butyrate 22 C and then Glucose 22 C
Treatment:
Other: Glucose + ethyl butyrate
Other: Ethyl butyrate
Other: Glucose
Other: Glucose + ethyl butyrate 0 C
Other: Water
Gluc+EB_cold/gluc+EB/EB/water/glucose
Experimental group
Description:
First Glucose + Ethyl butyrate 0 C, then Glucose + Ethyl butyrate 22 C, then Ethyl butyrate 22 C, then Water 22 C and then Glucose 22 C
Treatment:
Other: Glucose + ethyl butyrate
Other: Ethyl butyrate
Other: Glucose
Other: Glucose + ethyl butyrate 0 C
Other: Water
Gluc+EB_cold/EB/gluc+EB/glucose/water
Experimental group
Description:
First Glucose + Ethyl butyrate 0 C, then Ethyl butyrate 22 C, then Glucose + Ethyl butyrate 22 C, then Glucose 22 C and then Water 22 C
Treatment:
Other: Glucose + ethyl butyrate
Other: Ethyl butyrate
Other: Glucose
Other: Glucose + ethyl butyrate 0 C
Other: Water

Trial contacts and locations

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