fMRI of Hypothalamic Responses to Glucose, Fructose, Sucrose and Sucralose

Functional Magnetic Resonance Imaging of Human Hypothalamic Responses to Glucose, Fructose, Sucrose and Sucralose

The study will consist of five occasions with one week in between. BOLD signal intensity of the hypothalamus will be measured using fMRI. Measurements will be done before and after drinking 300 ml plain water (reference) or water to which different sweeteners will be added.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Water; Other: Glucose; Other: Fructose; Other: Sucrose; Other: Sucralose

Detailed Description

The hypothalamus is known to be important for control of feeding behaviour as well as the regulation of temperature. Functional magnetic resonance imaging (fMRI) is a non-invasive method, which detects transient haemodynamic changes in the brain, using blood oxygen level dependent (BOLD) signal differences.

In order to investigate the role of hypothalamic neural activity in response to different sweeteners, fMRI will be performed before, during and after ingestion of 300 ml plain water or 300 ml water containing 50 g glucose, 50 g fructose, 50 g sucrose or 0.33 g sucralose (high intensity sweetener not providing energy). All beverages will be consumed at 22 °C.

The study uses a randomized cross-over design in 16 healthy male subjects with a normal body weight. There will be an interval of at least one week between the five occasions.

Blood Oxygen Level Dependent signal intensity of the hypothalamus will be continuously measured for 21 minutes (5 minutes baseline, 4 minutes during drinking and 12 minutes after drinking).

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands
      • Leids Universitair Medisch Centrum

Participation Criteria

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 24 kg/m2
• 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 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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Water-glucose-sucralose-fructose-sucrose; First plain water, then glucose, then sucralose, then fructose and then sucrose	Other: Water; Water, 300 ml at room temperature; Other: Glucose; Glucose, 50 grams in 300 ml water at room temperature; Other: Fructose; Fructose, 50 grams in 300 ml water at room temperature; Other: Sucrose; Sucrose, 50 grams in 300 ml water at room temperature; Other: Sucralose; Sucralose, 0.33 grams in 300 ml water at room temperature
Experimental: water-sucralose-glucose-sucrose-fructose; First plain water, then sucralose, then glucose, then sucrose and then fructose	Other: Water; Water, 300 ml at room temperature; Other: Glucose; Glucose, 50 grams in 300 ml water at room temperature; Other: Fructose; Fructose, 50 grams in 300 ml water at room temperature; Other: Sucrose; Sucrose, 50 grams in 300 ml water at room temperature; Other: Sucralose; Sucralose, 0.33 grams in 300 ml water at room temperature
Experimental: Glucose-water-fructose-sucralose-sucrose; First glucose, then plain water, then fructose, then sucralose and then sucrose	Other: Water; Water, 300 ml at room temperature; Other: Glucose; Glucose, 50 grams in 300 ml water at room temperature; Other: Fructose; Fructose, 50 grams in 300 ml water at room temperature; Other: Sucrose; Sucrose, 50 grams in 300 ml water at room temperature; Other: Sucralose; Sucralose, 0.33 grams in 300 ml water at room temperature
Experimental: Glucose-fructose-water-sucrose-sucralose; First glucose, then fructose, then plain water, then sucrose and then sucralose	Other: Water; Water, 300 ml at room temperature; Other: Glucose; Glucose, 50 grams in 300 ml water at room temperature; Other: Fructose; Fructose, 50 grams in 300 ml water at room temperature; Other: Sucrose; Sucrose, 50 grams in 300 ml water at room temperature; Other: Sucralose; Sucralose, 0.33 grams in 300 ml water at room temperature
Experimental: Fructose-glucose-sucrose-water-sucralose; First fructose, then glucose, then sucrose, then plain water and then sucralose	Other: Water; Water, 300 ml at room temperature; Other: Glucose; Glucose, 50 grams in 300 ml water at room temperature; Other: Fructose; Fructose, 50 grams in 300 ml water at room temperature; Other: Sucrose; Sucrose, 50 grams in 300 ml water at room temperature; Other: Sucralose; Sucralose, 0.33 grams in 300 ml water at room temperature
Experimental: Fructose-sucrose-glucose-sucralose-water; First fructose, then sucrose, then glucose, then sucralose and then plain water	Other: Water; Water, 300 ml at room temperature; Other: Glucose; Glucose, 50 grams in 300 ml water at room temperature; Other: Fructose; Fructose, 50 grams in 300 ml water at room temperature; Other: Sucrose; Sucrose, 50 grams in 300 ml water at room temperature; Other: Sucralose; Sucralose, 0.33 grams in 300 ml water at room temperature
Experimental: Sucrose-fructose-sucralose-glucose-water; First sucrose, then fructose, then sucralose, then glucose and then plain water	Other: Water; Water, 300 ml at room temperature; Other: Glucose; Glucose, 50 grams in 300 ml water at room temperature; Other: Fructose; Fructose, 50 grams in 300 ml water at room temperature; Other: Sucrose; Sucrose, 50 grams in 300 ml water at room temperature; Other: Sucralose; Sucralose, 0.33 grams in 300 ml water at room temperature
Experimental: Sucrose-sucralose-fructose-water-glucose; First sucrose, then sucralose, then fructose, then plain water and then glucose	Other: Water; Water, 300 ml at room temperature; Other: Glucose; Glucose, 50 grams in 300 ml water at room temperature; Other: Fructose; Fructose, 50 grams in 300 ml water at room temperature; Other: Sucrose; Sucrose, 50 grams in 300 ml water at room temperature; Other: Sucralose; Sucralose, 0.33 grams in 300 ml water at room temperature
Experimental: Sucralose-water-sucrose-glucose-fructose; First sucralose, then plain water, then sucrose, then glucose and then fructose	Other: Water; Water, 300 ml at room temperature; Other: Glucose; Glucose, 50 grams in 300 ml water at room temperature; Other: Fructose; Fructose, 50 grams in 300 ml water at room temperature; Other: Sucrose; Sucrose, 50 grams in 300 ml water at room temperature; Other: Sucralose; Sucralose, 0.33 grams in 300 ml water at room temperature
Experimental: Sucralose-sucrose-water-fructose-glucose; First sucralose, then sucrose, then plain water, then fructose and then glucose	Other: Water; Water, 300 ml at room temperature; Other: Glucose; Glucose, 50 grams in 300 ml water at room temperature; Other: Fructose; Fructose, 50 grams in 300 ml water at room temperature; Other: Sucrose; Sucrose, 50 grams in 300 ml water at room temperature; Other: Sucralose; Sucralose, 0.33 grams in 300 ml water at room temperature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypothalamic function in response to glucose, fructose, sucrose, and sucralose	fMRI will be performed before and after ingestion	Change from baseline (measured during 5 minutes before start of dinking) to post consumption (measured during 12 minutes after drinking). Drinking took 4 minutes.

Collaborators and Investigators

• 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

General Publications

• van Opstal AM, Hafkemeijer A, van den Berg-Huysmans AA, Hoeksma M, Blonk C, Pijl H, Rombouts SARB, van der Grond J. Brain activity and connectivity changes in response to glucose ingestion. Nutr Neurosci. 2020 Feb;23(2):110-117. doi: 10.1080/1028415X.2018.1477538. Epub 2018 May 27.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2015
• Primary Completion (Actual): May 22, 2015
• Study Completion (Actual): May 22, 2015

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 10, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 1930

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No