RS-fMRI to Nutrient Shakes

Pleasure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02745730
• Other study ID #: REF-ICE-2421
• Status: Completed
• Phase: N/A
• First received: April 4, 2016
• Last updated: November 18, 2016
• Start date: March 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pleasure

Intervention

Other:
• Glucose

• Fructose

• Sucralose

• Allulose

Locations

Country	Name	City	State
Netherlands	Leids Universitair Medisch Centrum	Leiden	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Unilever R&D	Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.		Six minutes before (baseline) and 12 minutes after (response) test product intake	No
Other	Changes from baseline in the BOLD signal	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	No
Primary	Change from baseline in the connectivity in the default mode and salience network: glucose and fructose vs. sucralose and allulose.		Six minutes before (baseline) and 12 minutes after (response) test product intake	No
Secondary	2. Change from baseline in the connectivity in the default mode and salience network: glucose vs. fructose.		Six minutes before (baseline) and 12 minutes after (response) test product intake	No
Secondary	3. Change from baseline in the connectivity in the default mode and salience network: allulose vs. sucralose.		Six minutes before (baseline) and 12 minutes after (response) test product intake	No