fMRI of Hypothalamic Responses to Glucose, Fructose, Sucrose and Sucralose

NCT ID: NCT03247114

Last Updated: 2017-08-11

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

2015-02-22

Study Completion Date

2015-05-22

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 (reference) or water to which different sweeteners 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 different sweeteners, fMRI will be performed before, during and after ingestion of 300 ml plain water or 300 ml water containing 50 g glucose, 50 g fructose, 50 g sucrose or 0.33 g sucralose (high intensity sweetener not providing energy). All beverages will be consumed at 22 °C.

The study uses a randomized 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.

Blood Oxygen Level Dependent 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-glucose-sucralose-fructose-sucrose

First plain water, then glucose, then sucralose, then fructose and then sucrose

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml at room temperature

Glucose

Intervention Type OTHER

Glucose, 50 grams in 300 ml water at room temperature

Fructose

Intervention Type OTHER

Fructose, 50 grams in 300 ml water at room temperature

Sucrose

Intervention Type OTHER

Sucrose, 50 grams in 300 ml water at room temperature

Sucralose

Intervention Type OTHER

Sucralose, 0.33 grams in 300 ml water at room temperature

water-sucralose-glucose-sucrose-fructose

First plain water, then sucralose, then glucose, then sucrose and then fructose

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml at room temperature

Glucose

Intervention Type OTHER

Glucose, 50 grams in 300 ml water at room temperature

Fructose

Intervention Type OTHER

Fructose, 50 grams in 300 ml water at room temperature

Sucrose

Intervention Type OTHER

Sucrose, 50 grams in 300 ml water at room temperature

Sucralose

Intervention Type OTHER

Sucralose, 0.33 grams in 300 ml water at room temperature

Glucose-water-fructose-sucralose-sucrose

First glucose, then plain water, then fructose, then sucralose and then sucrose

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml at room temperature

Glucose

Intervention Type OTHER

Glucose, 50 grams in 300 ml water at room temperature

Fructose

Intervention Type OTHER

Fructose, 50 grams in 300 ml water at room temperature

Sucrose

Intervention Type OTHER

Sucrose, 50 grams in 300 ml water at room temperature

Sucralose

Intervention Type OTHER

Sucralose, 0.33 grams in 300 ml water at room temperature

Glucose-fructose-water-sucrose-sucralose

First glucose, then fructose, then plain water, then sucrose and then sucralose

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml at room temperature

Glucose

Intervention Type OTHER

Glucose, 50 grams in 300 ml water at room temperature

Fructose

Intervention Type OTHER

Fructose, 50 grams in 300 ml water at room temperature

Sucrose

Intervention Type OTHER

Sucrose, 50 grams in 300 ml water at room temperature

Sucralose

Intervention Type OTHER

Sucralose, 0.33 grams in 300 ml water at room temperature

Fructose-glucose-sucrose-water-sucralose

First fructose, then glucose, then sucrose, then plain water and then sucralose

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml at room temperature

Glucose

Intervention Type OTHER

Glucose, 50 grams in 300 ml water at room temperature

Fructose

Intervention Type OTHER

Fructose, 50 grams in 300 ml water at room temperature

Sucrose

Intervention Type OTHER

Sucrose, 50 grams in 300 ml water at room temperature

Sucralose

Intervention Type OTHER

Sucralose, 0.33 grams in 300 ml water at room temperature

Fructose-sucrose-glucose-sucralose-water

First fructose, then sucrose, then glucose, then sucralose and then plain water

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml at room temperature

Glucose

Intervention Type OTHER

Glucose, 50 grams in 300 ml water at room temperature

Fructose

Intervention Type OTHER

Fructose, 50 grams in 300 ml water at room temperature

Sucrose

Intervention Type OTHER

Sucrose, 50 grams in 300 ml water at room temperature

Sucralose

Intervention Type OTHER

Sucralose, 0.33 grams in 300 ml water at room temperature

Sucrose-fructose-sucralose-glucose-water

First sucrose, then fructose, then sucralose, then glucose and then plain water

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml at room temperature

Glucose

Intervention Type OTHER

Glucose, 50 grams in 300 ml water at room temperature

Fructose

Intervention Type OTHER

Fructose, 50 grams in 300 ml water at room temperature

Sucrose

Intervention Type OTHER

Sucrose, 50 grams in 300 ml water at room temperature

Sucralose

Intervention Type OTHER

Sucralose, 0.33 grams in 300 ml water at room temperature

Sucrose-sucralose-fructose-water-glucose

First sucrose, then sucralose, then fructose, then plain water and then glucose

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml at room temperature

Glucose

Intervention Type OTHER

Glucose, 50 grams in 300 ml water at room temperature

Fructose

Intervention Type OTHER

Fructose, 50 grams in 300 ml water at room temperature

Sucrose

Intervention Type OTHER

Sucrose, 50 grams in 300 ml water at room temperature

Sucralose

Intervention Type OTHER

Sucralose, 0.33 grams in 300 ml water at room temperature

Sucralose-water-sucrose-glucose-fructose

First sucralose, then plain water, then sucrose, then glucose and then fructose

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml at room temperature

Glucose

Intervention Type OTHER

Glucose, 50 grams in 300 ml water at room temperature

Fructose

Intervention Type OTHER

Fructose, 50 grams in 300 ml water at room temperature

Sucrose

Intervention Type OTHER

Sucrose, 50 grams in 300 ml water at room temperature

Sucralose

Intervention Type OTHER

Sucralose, 0.33 grams in 300 ml water at room temperature

Sucralose-sucrose-water-fructose-glucose

First sucralose, then sucrose, then plain water, then fructose and then glucose

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Water, 300 ml at room temperature

Glucose

Intervention Type OTHER

Glucose, 50 grams in 300 ml water at room temperature

Fructose

Intervention Type OTHER

Fructose, 50 grams in 300 ml water at room temperature

Sucrose

Intervention Type OTHER

Sucrose, 50 grams in 300 ml water at room temperature

Sucralose

Intervention Type OTHER

Sucralose, 0.33 grams in 300 ml water at room temperature

Interventions

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Water

Water, 300 ml at room temperature

Intervention Type OTHER

Glucose

Glucose, 50 grams in 300 ml water at room temperature

Intervention Type OTHER

Fructose

Fructose, 50 grams in 300 ml water at room temperature

Intervention Type OTHER

Sucrose

Sucrose, 50 grams in 300 ml water at room temperature

Intervention Type OTHER

Sucralose

Sucralose, 0.33 grams in 300 ml water at room temperature

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Age between 18 and 25 years
* BMI between 20 and 24 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, Dr

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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1930

Identifier Type: -

Identifier Source: org_study_id

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