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

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Unilever

Status

Completed

Conditions

Healthy

Treatments

Other: Fructose
Other: Water
Other: Glucose
Other: Sucrose
Other: Sucralose

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03247114
1930

Details and patient eligibility

About

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.

Full 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).

Read more

Enrollment

16 patients

Sex

Male

Ages

18 to 25 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

16 participants in 10 patient groups

Water-glucose-sucralose-fructose-sucrose
Experimental group
Description:
First plain water, then glucose, then sucralose, then fructose and then sucrose
Treatment:
Other: Sucrose
Other: Sucralose
Other: Glucose
Other: Water
Other: Fructose
water-sucralose-glucose-sucrose-fructose
Experimental group
Description:
First plain water, then sucralose, then glucose, then sucrose and then fructose
Treatment:
Other: Sucrose
Other: Sucralose
Other: Glucose
Other: Water
Other: Fructose
Glucose-water-fructose-sucralose-sucrose
Experimental group
Description:
First glucose, then plain water, then fructose, then sucralose and then sucrose
Treatment:
Other: Sucrose
Other: Sucralose
Other: Glucose
Other: Water
Other: Fructose
Glucose-fructose-water-sucrose-sucralose
Experimental group
Description:
First glucose, then fructose, then plain water, then sucrose and then sucralose
Treatment:
Other: Sucrose
Other: Sucralose
Other: Glucose
Other: Water
Other: Fructose
Fructose-glucose-sucrose-water-sucralose
Experimental group
Description:
First fructose, then glucose, then sucrose, then plain water and then sucralose
Treatment:
Other: Sucrose
Other: Sucralose
Other: Glucose
Other: Water
Other: Fructose
Fructose-sucrose-glucose-sucralose-water
Experimental group
Description:
First fructose, then sucrose, then glucose, then sucralose and then plain water
Treatment:
Other: Sucrose
Other: Sucralose
Other: Glucose
Other: Water
Other: Fructose
Sucrose-fructose-sucralose-glucose-water
Experimental group
Description:
First sucrose, then fructose, then sucralose, then glucose and then plain water
Treatment:
Other: Sucrose
Other: Sucralose
Other: Glucose
Other: Water
Other: Fructose
Sucrose-sucralose-fructose-water-glucose
Experimental group
Description:
First sucrose, then sucralose, then fructose, then plain water and then glucose
Treatment:
Other: Sucrose
Other: Sucralose
Other: Glucose
Other: Water
Other: Fructose
Sucralose-water-sucrose-glucose-fructose
Experimental group
Description:
First sucralose, then plain water, then sucrose, then glucose and then fructose
Treatment:
Other: Sucrose
Other: Sucralose
Other: Glucose
Other: Water
Other: Fructose
Sucralose-sucrose-water-fructose-glucose
Experimental group
Description:
First sucralose, then sucrose, then plain water, then fructose and then glucose
Treatment:
Other: Sucrose
Other: Sucralose
Other: Glucose
Other: Water
Other: Fructose

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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