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RS-fMRI to Nutrient Shakes

NCT ID: NCT02745730

Last Updated: 2016-11-21

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-10-31

Brief Summary

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Resting state functional magnetic resonance imaging (rsfMRl) of the brain is used to measure pleasantness after consumption of four different milkshakes with added sugars or sweeteners.

Detailed Description

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The central role of the brain in regulating food intake and steering feeding behaviour is increasingly recognized. It is currently well accepted that the brain is the target organ to measure the effects of pleasantness and energy homeostasis in order to change feeding behaviour to reduce the rising prevalence of obesity. The effects of food on the brain are multiple and complex. In addition to primary aspects of food such as taste, texture, looks and smell, secondary aspects such as energy regulation are as much important in the entire "eating experience". Resting state functional connectivity in the brain can be assessed by the analysis of low-frequency fluctuations present in the blood-oxygenation-level-dependent (BOLD) signal in functional magnetic resonance imaging (fMRI). Investigators will use resting state functional magnetic resonance imaging (rsfMRl) to detect changes in connectivity in the default mode and salience network after consumption of four different milkshakes with added sugars or sweeteners.

Conditions

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Pleasure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Glucose

Shake sweetened with glucose

Group Type ACTIVE_COMPARATOR

Glucose

Intervention Type OTHER

Fructose

Shake sweetened with fructose

Group Type ACTIVE_COMPARATOR

Fructose

Intervention Type OTHER

Sucralose

Shake sweetened with sucralose

Group Type EXPERIMENTAL

Sucralose

Intervention Type OTHER

Allulose

Shake sweetened with allulose

Group Type EXPERIMENTAL

Allulose

Intervention Type OTHER

Interventions

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Glucose

Intervention Type OTHER

Fructose

Intervention Type OTHER

Sucralose

Intervention Type OTHER

Allulose

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Age between 18 and 25 years
* BMI between 20 and 23 kg/m2
* Weight above 70 kg
* 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 know food allergy or intolerance
* 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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Lodi A, Zarantonello L, Bisiacchi PS, Cenci L, Paoli A. Ketonemia and Glycemia Affect Appetite Levels and Executive Functions in Overweight Females During Two Ketogenic Diets. Obesity (Silver Spring). 2020 Oct;28(10):1868-1877. doi: 10.1002/oby.22934. Epub 2020 Sep 1.

Reference Type DERIVED
PMID: 32875733 (View on PubMed)

Van Opstal AM, Hafkemeijer A, van den Berg-Huysmans AA, Hoeksma M, Mulder TPJ, Pijl H, Rombouts SARB, van der Grond J. Brain activity and connectivity changes in response to nutritive natural sugars, non-nutritive natural sugar replacements and artificial sweeteners. Nutr Neurosci. 2021 May;24(5):395-405. doi: 10.1080/1028415X.2019.1639306. Epub 2019 Jul 10.

Reference Type DERIVED
PMID: 31288630 (View on PubMed)

Other Identifiers

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REF-ICE-2421

Identifier Type: -

Identifier Source: org_study_id