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HealthyCOLD-2NCT03202342

fMRI of Hypothalamic Responses to Taste, Temperature and Glucose

A study testing Water, Glucose and Ethyl butyrate in people with Healthy, run by Unilever R&D at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 25 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Water, Glucose and Ethyl butyrate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteNetherlands
Study dates
11 Nov 2013to 30 Oct 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Signed informed consent
  • Age between 18 and 25 years
  • BMI between 20 and 23 kg/m2
  • Length between 170 and 190 centimetres

Who cannot join

  • 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)
Show all 17Show fewer
  • 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 locations and contacts

1 site in 1 country.

Netherlands1 site

  • Leids Universitair Medisch Centrum

    Leiden, South Holland

Other trials in Netherlands

About this study

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

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.

Read the detailed 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).

Conditions
Healthy
Being tested
Water, Glucose, Ethyl butyrate, Glucose + ethyl butyrate, Glucose + ethyl butyrate 0 C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WaterOther

    Water, 300 ml, at room temperature

  • GlucoseOther

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

  • Ethyl butyrateOther

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

  • Glucose + ethyl butyrateOther

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

  • Glucose + ethyl butyrate 0 COther

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

Study groups in NCT03202342
Study groupRoleWhat they receive
Water/gluc/gluc+EB/EB/gluc+EB_coldExperimentalFirst 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
Receives: Other: Water; Other: Glucose; Other: Ethyl butyrate; Other: Glucose + ethyl butyrate; Other: Glucose + ethyl butyrate 0 C
Water/gluc+EB/gluc/gluc+EB_cold/EBExperimentalFirst 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
Receives: Other: Water; Other: Glucose; Other: Ethyl butyrate; Other: Glucose + ethyl butyrate; Other: Glucose + ethyl butyrate 0 C
Gluc/water/EB/gluc+EB/glucose+EB_coldExperimentalFirst 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
Receives: Other: Water; Other: Glucose; Other: Ethyl butyrate; Other: Glucose + ethyl butyrate; Other: Glucose + ethyl butyrate 0 C
Gluc/EB/water/gluc+EB_cold/gluc+EBExperimentalFirst 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
Receives: Other: Water; Other: Glucose; Other: Ethyl butyrate; Other: Glucose + ethyl butyrate; Other: Glucose + ethyl butyrate 0 C
EB/Gluc/gluc+EB_cold/water/glucose+EBExperimentalFirst 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
Receives: Other: Water; Other: Glucose; Other: Ethyl butyrate; Other: Glucose + ethyl butyrate; Other: Glucose + ethyl butyrate 0 C
EB/gluc+EB_cold/gluc/glucose+EB/waterExperimentalFirst 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
Receives: Other: Water; Other: Glucose; Other: Ethyl butyrate; Other: Glucose + ethyl butyrate; Other: Glucose + ethyl butyrate 0 C
Gluc+EB_cold/water/glucose+EB/glucose/EBExperimentalFirst 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
Receives: Other: Water; Other: Glucose; Other: Ethyl butyrate; Other: Glucose + ethyl butyrate; Other: Glucose + ethyl butyrate 0 C
Gluc+EB_cold/glucose+EB/water/EB/glucoseExperimentalFirst 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
Receives: Other: Water; Other: Glucose; Other: Ethyl butyrate; Other: Glucose + ethyl butyrate; Other: Glucose + ethyl butyrate 0 C
Gluc+EB_cold/gluc+EB/EB/water/glucoseExperimentalFirst 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
Receives: Other: Water; Other: Glucose; Other: Ethyl butyrate; Other: Glucose + ethyl butyrate; Other: Glucose + ethyl butyrate 0 C
Gluc+EB_cold/EB/gluc+EB/glucose/waterExperimentalFirst 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
Receives: Other: Water; Other: Glucose; Other: Ethyl butyrate; Other: Glucose + ethyl butyrate; Other: Glucose + ethyl butyrate 0 C

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    BOLD-signal intensity

    Measured: Before (5 minutes) and after (12 minutes) drinking

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2017
  2. Study start11 Nov 2013
  3. Primary completion30 Oct 2014
  4. Study completion30 Oct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03202342
Sponsor's protocol ID
1302
Acronym
COLD-2
Status last verified
Jun 2017
First submitted
26 Jun 2017
Last updated
28 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29806553

Questions about this trial

What is this clinical trial studying?

A study testing Water, Glucose and Ethyl butyrate in people with Healthy, run by Unilever R&D at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine hypothalamic function in response to taste, temperature and glucose sensing (time frame: Before (5 minutes) and after (12 minutes) drinking). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03202342, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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