RS-fMRI to Nutrient Shakes

November 18, 2016 updated by: Unilever R&D

Resting State Functional Magnetic Resonance Imaging of Human Brain Responses to Nutrient Shake

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • 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

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
  • 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

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: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Glucose
Shake sweetened with glucose
Other: Glucose
ACTIVE_COMPARATOR: Fructose
Shake sweetened with fructose
Other: Fructose
EXPERIMENTAL: Sucralose
Shake sweetened with sucralose
Other: Sucralose
EXPERIMENTAL: Allulose
Shake sweetened with allulose
Other: Allulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the connectivity in the default mode and salience network: glucose and fructose vs. sucralose and allulose.
Time Frame: Six minutes before (baseline) and 12 minutes after (response) test product intake
Six minutes before (baseline) and 12 minutes after (response) test product intake

Secondary Outcome Measures

Outcome Measure
Time Frame
2. Change from baseline in the connectivity in the default mode and salience network: glucose vs. fructose.
Time Frame: Six minutes before (baseline) and 12 minutes after (response) test product intake
Six minutes before (baseline) and 12 minutes after (response) test product intake
3. Change from baseline in the connectivity in the default mode and salience network: allulose vs. sucralose.
Time Frame: Six minutes before (baseline) and 12 minutes after (response) test product intake
Six minutes before (baseline) and 12 minutes after (response) test product intake

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
4. Change from baseline in the connectivity in the default mode and salience network: glucose vs allulose; glucose vs sucralose; fructose vs sucralose and fructose vs allulose.
Time Frame: Six minutes before (baseline) and 12 minutes after (response) test product intake
Six minutes before (baseline) and 12 minutes after (response) test product intake
Changes from baseline in the BOLD signal
Time Frame: Six minutes before (baseline) and 12 minutes after (response) test product intake
Using whole brain approach as well as seed based (hypothalamus, prefrontal cortex, nucleus accumbens, Ventral Tegmental Area, Amygdala).
Six minutes before (baseline) and 12 minutes after (response) test product intake

Collaborators and Investigators

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

Sponsor

Unilever R&D

Collaborators

Leiden University Medical Center

Investigators

  • Principal Investigator: Jeroen van der Grond, Dr., 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

March 1, 2016

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

April 15, 2016

First Posted (ESTIMATE)

April 20, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 18, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • REF-ICE-2421

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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