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

June 26, 2017 updated by: Unilever R&D

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands
        • Leids Universitair Medisch Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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
Other: Water
Water, 300 ml, at room temperature
Other: Glucose
Water containing 50 g glucose, 300 ml, at room temperature
Other: Ethyl butyrate
Water containing ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate 0 C
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at 0 degrees centigrade
EXPERIMENTAL: 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
Other: Water
Water, 300 ml, at room temperature
Other: Glucose
Water containing 50 g glucose, 300 ml, at room temperature
Other: Ethyl butyrate
Water containing ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate 0 C
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at 0 degrees centigrade
EXPERIMENTAL: 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
Other: Water
Water, 300 ml, at room temperature
Other: Glucose
Water containing 50 g glucose, 300 ml, at room temperature
Other: Ethyl butyrate
Water containing ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate 0 C
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at 0 degrees centigrade
EXPERIMENTAL: 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
Other: Water
Water, 300 ml, at room temperature
Other: Glucose
Water containing 50 g glucose, 300 ml, at room temperature
Other: Ethyl butyrate
Water containing ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate 0 C
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at 0 degrees centigrade
EXPERIMENTAL: 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
Other: Water
Water, 300 ml, at room temperature
Other: Glucose
Water containing 50 g glucose, 300 ml, at room temperature
Other: Ethyl butyrate
Water containing ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate 0 C
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at 0 degrees centigrade
EXPERIMENTAL: 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
Other: Water
Water, 300 ml, at room temperature
Other: Glucose
Water containing 50 g glucose, 300 ml, at room temperature
Other: Ethyl butyrate
Water containing ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate 0 C
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at 0 degrees centigrade
EXPERIMENTAL: 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
Other: Water
Water, 300 ml, at room temperature
Other: Glucose
Water containing 50 g glucose, 300 ml, at room temperature
Other: Ethyl butyrate
Water containing ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate 0 C
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at 0 degrees centigrade
EXPERIMENTAL: 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
Other: Water
Water, 300 ml, at room temperature
Other: Glucose
Water containing 50 g glucose, 300 ml, at room temperature
Other: Ethyl butyrate
Water containing ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate 0 C
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at 0 degrees centigrade
EXPERIMENTAL: 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
Other: Water
Water, 300 ml, at room temperature
Other: Glucose
Water containing 50 g glucose, 300 ml, at room temperature
Other: Ethyl butyrate
Water containing ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate 0 C
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at 0 degrees centigrade
EXPERIMENTAL: 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
Other: Water
Water, 300 ml, at room temperature
Other: Glucose
Water containing 50 g glucose, 300 ml, at room temperature
Other: Ethyl butyrate
Water containing ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Other: Glucose + ethyl butyrate 0 C
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at 0 degrees centigrade

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determine hypothalamic function in response to taste, temperature and glucose sensing
Time Frame: Before (5 minutes) and after (12 minutes) drinking
BOLD-signal intensity
Before (5 minutes) and after (12 minutes) drinking

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unilever R&D

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Leiden University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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