fMRI of Hypothalamic Responses to Taste, Temperature and Glucose
COLD-2
Functional Magnetic Resonance Imaging of Human Hypothalamic Responses to Taste, Temperature and Glucose Sensing
1 other identifier
interventional
16
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Nov 2013
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2014
CompletedFirst Submitted
Initial submission to the registry
June 26, 2017
CompletedFirst Posted
Study publicly available on registry
June 28, 2017
CompletedJune 28, 2017
June 1, 2017
12 months
June 26, 2017
June 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Determine hypothalamic function in response to taste, temperature and glucose sensing
BOLD-signal intensity
Before (5 minutes) and after (12 minutes) drinking
Study Arms (10)
Water/gluc/gluc+EB/EB/gluc+EB_cold
EXPERIMENTALFirst 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
Water/gluc+EB/gluc/gluc+EB_cold/EB
EXPERIMENTALFirst 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
Gluc/water/EB/gluc+EB/glucose+EB_cold
EXPERIMENTALFirst 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
Gluc/EB/water/gluc+EB_cold/gluc+EB
EXPERIMENTALFirst 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
EB/Gluc/gluc+EB_cold/water/glucose+EB
EXPERIMENTALFirst 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
EB/gluc+EB_cold/gluc/glucose+EB/water
EXPERIMENTALFirst 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
Gluc+EB_cold/water/glucose+EB/glucose/EB
EXPERIMENTALFirst 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
Gluc+EB_cold/glucose+EB/water/EB/glucose
EXPERIMENTALFirst 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
Gluc+EB_cold/gluc+EB/EB/water/glucose
EXPERIMENTALFirst 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
Gluc+EB_cold/EB/gluc+EB/glucose/water
EXPERIMENTALFirst 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
Interventions
Water, 300 ml, at room temperature
Water containing 50 g glucose, 300 ml, at room temperature
Water containing ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at room temperature
Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at 0 degrees centigrade
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Age between 18 and 25 years
- BMI between 20 and 23 kg/m2
- Length between 170 and 190 centimetres
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Unilever R&Dlead
- Leiden University Medical Centercollaborator
Study Sites (1)
Leids Universitair Medisch Centrum
Leiden, South Holland, Netherlands
Related Publications (1)
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.
PMID: 29806553DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeroen van der Grond
Leiden University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2017
First Posted
June 28, 2017
Study Start
November 11, 2013
Primary Completion
October 30, 2014
Study Completion
October 30, 2014
Last Updated
June 28, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share