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Completed

NCT Number: NCT02745730

RS-fMRI to Nutrient Shakes

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.

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Key information

Conditions

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose

Other

Fructose

Other

Sucralose

Other

Allulose

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Other outcomes

  1. 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

  2. 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).

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Collaborators

  • Leiden University Medical Center

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 20, 2016
Registry last updated
Nov 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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