fMRI of Hypothalamic Responses to Taste, Temperature and Glucose

NCT ID: NCT03202342

Last Updated: 2017-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-11

Study Completion Date

2014-10-30

Brief Summary

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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

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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).

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Water/gluc/gluc+EB/EB/gluc+EB_cold

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

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml, at room temperature

Glucose

Intervention Type OTHER

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

Ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate 0 C

Intervention Type OTHER

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

Water/gluc+EB/gluc/gluc+EB_cold/EB

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

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml, at room temperature

Glucose

Intervention Type OTHER

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

Ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate 0 C

Intervention Type OTHER

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

Gluc/water/EB/gluc+EB/glucose+EB_cold

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

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml, at room temperature

Glucose

Intervention Type OTHER

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

Ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate 0 C

Intervention Type OTHER

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

Gluc/EB/water/gluc+EB_cold/gluc+EB

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

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml, at room temperature

Glucose

Intervention Type OTHER

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

Ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate 0 C

Intervention Type OTHER

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

EB/Gluc/gluc+EB_cold/water/glucose+EB

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

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml, at room temperature

Glucose

Intervention Type OTHER

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

Ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate 0 C

Intervention Type OTHER

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

EB/gluc+EB_cold/gluc/glucose+EB/water

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

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml, at room temperature

Glucose

Intervention Type OTHER

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

Ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate 0 C

Intervention Type OTHER

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

Gluc+EB_cold/water/glucose+EB/glucose/EB

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

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml, at room temperature

Glucose

Intervention Type OTHER

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

Ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate 0 C

Intervention Type OTHER

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

Gluc+EB_cold/glucose+EB/water/EB/glucose

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

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml, at room temperature

Glucose

Intervention Type OTHER

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

Ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate 0 C

Intervention Type OTHER

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

Gluc+EB_cold/gluc+EB/EB/water/glucose

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

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml, at room temperature

Glucose

Intervention Type OTHER

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

Ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate 0 C

Intervention Type OTHER

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

Gluc+EB_cold/EB/gluc+EB/glucose/water

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

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml, at room temperature

Glucose

Intervention Type OTHER

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

Ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate

Intervention Type OTHER

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

Glucose + ethyl butyrate 0 C

Intervention Type OTHER

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

Interventions

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Water

Water, 300 ml, at room temperature

Intervention Type OTHER

Glucose

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

Intervention Type OTHER

Ethyl butyrate

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

Intervention Type OTHER

Glucose + ethyl butyrate

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

Intervention Type OTHER

Glucose + ethyl butyrate 0 C

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role collaborator

Unilever R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeroen van der Grond

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

Site Status

Countries

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Netherlands

References

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van Opstal AM, Hafkemeijer A, van den Berg-Huysmans AA, Hoeksma M, Blonk C, Pijl H, Rombouts SARB, van der Grond J. Brain activity and connectivity changes in response to glucose ingestion. Nutr Neurosci. 2020 Feb;23(2):110-117. doi: 10.1080/1028415X.2018.1477538. Epub 2018 May 27.

Reference Type DERIVED
PMID: 29806553 (View on PubMed)

Other Identifiers

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1302

Identifier Type: -

Identifier Source: org_study_id

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