fMRI of Hypothalamic Responses to Glucose, Fructose, Sucrose and Sucralose
Functional Magnetic Resonance Imaging of Human Hypothalamic Responses to Glucose, Fructose, Sucrose and Sucralose
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 (reference) or water to which different sweeteners 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 Feb 2015
Shorter than P25 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
February 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2015
CompletedFirst Submitted
Initial submission to the registry
August 7, 2017
CompletedFirst Posted
Study publicly available on registry
August 11, 2017
CompletedAugust 11, 2017
August 1, 2017
3 months
August 7, 2017
August 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Hypothalamic function in response to glucose, fructose, sucrose, and sucralose
fMRI will be performed before and after ingestion
Change from baseline (measured during 5 minutes before start of dinking) to post consumption (measured during 12 minutes after drinking). Drinking took 4 minutes.
Study Arms (10)
Water-glucose-sucralose-fructose-sucrose
EXPERIMENTALFirst plain water, then glucose, then sucralose, then fructose and then sucrose
water-sucralose-glucose-sucrose-fructose
EXPERIMENTALFirst plain water, then sucralose, then glucose, then sucrose and then fructose
Glucose-water-fructose-sucralose-sucrose
EXPERIMENTALFirst glucose, then plain water, then fructose, then sucralose and then sucrose
Glucose-fructose-water-sucrose-sucralose
EXPERIMENTALFirst glucose, then fructose, then plain water, then sucrose and then sucralose
Fructose-glucose-sucrose-water-sucralose
EXPERIMENTALFirst fructose, then glucose, then sucrose, then plain water and then sucralose
Fructose-sucrose-glucose-sucralose-water
EXPERIMENTALFirst fructose, then sucrose, then glucose, then sucralose and then plain water
Sucrose-fructose-sucralose-glucose-water
EXPERIMENTALFirst sucrose, then fructose, then sucralose, then glucose and then plain water
Sucrose-sucralose-fructose-water-glucose
EXPERIMENTALFirst sucrose, then sucralose, then fructose, then plain water and then glucose
Sucralose-water-sucrose-glucose-fructose
EXPERIMENTALFirst sucralose, then plain water, then sucrose, then glucose and then fructose
Sucralose-sucrose-water-fructose-glucose
EXPERIMENTALFirst sucralose, then sucrose, then plain water, then fructose and then glucose
Interventions
Water, 300 ml at room temperature
Glucose, 50 grams in 300 ml water at room temperature
Fructose, 50 grams in 300 ml water at room temperature
Sucrose, 50 grams in 300 ml water at room temperature
Sucralose, 0.33 grams in 300 ml water at room temperature
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Age between 18 and 25 years
- BMI between 20 and 24 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, Dr
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
August 7, 2017
First Posted
August 11, 2017
Study Start
February 22, 2015
Primary Completion
May 22, 2015
Study Completion
May 22, 2015
Last Updated
August 11, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share