RS-fMRI to Nutrient Shakes

Not Applicable

Completed

• Conditions: Pleasure
• Interventions: Other: Glucose; Other: Sucralose; Other: Allulose; Other: Fructose

• Registration Number: NCT02745730
• Lead Sponsor: Unilever R&D

Brief 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.

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 Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-04-04
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-20
• Primary Completion: 2016-06
• Study Completion: 2016-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2016-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glucose	Glucose	Shake sweetened with glucose
Sucralose	Sucralose	Shake sweetened with sucralose
Allulose	Allulose	Shake sweetened with allulose
Fructose	Fructose	Shake sweetened with fructose

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Leids Universitair Medisch Centrum; 🇳🇱 Leiden, Zuid-Holland, Netherlands