Overview

This trial has been completed.

Condition pleasure
Treatments glucose, fructose, sucralose, allulose
Sponsor Unilever R&D
Collaborator Leiden University Medical Center
Start date March 2016
End date June 2016
Trial size 20 participants
Trial identifier NCT02745730, REF-ICE-2421

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Active Comparator)
Shake sweetened with glucose
glucose
(Active Comparator)
Shake sweetened with fructose
fructose
(Experimental)
Shake sweetened with sucralose
sucralose
(Experimental)
Shake sweetened with allulose
allulose

Primary Outcomes

Measure
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

Measure
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
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

Eligibility Criteria

Male participants from 18 years up to 25 years old.

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

Additional Information

Official title Resting State Functional Magnetic Resonance Imaging of Human Brain Responses to Nutrient Shake
Principal investigator Jeroen van der Grond, Dr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Unilever R&D.