Functional Magnetic Resonance Imaging of Human Hypothalamic Responses to Oral Temperature and Glucose Sensing

NCT03181217 | Completed

• 1 other identifier: FDS-BNH-0770
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The study will consist of four occasions with one week between the occasions. fMRI will be performed to monitor hypothalamic activity before and after an ingestion of 1 of the following 4 stimuli (300 ml of each): water at room temperature, water at 0 degrees Celsius, glucose solution at room temperature, glucose solution at 0 degrees Celsius. The last two stimuli both contain 75 gram glucose. The order of conditions will be randomly assigned to the subjects. Functional connectivity of the hypothalamic regions will be assessed by analysing the resting state fMRI.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Functional magnetic resonance imaging of the hypothalamus

  Hypothalamic neural activity measured using Blood Oxygen Level Dependent signal measured by functional magnetic resonance imaging

  fMRI measurements between 8 and 20 minutes after start of beverage intake

Secondary Outcomes (2)

• Functional magnetic resonance imaging of the amygdala

  fMRI measurements between 8 and 20 minutes after start of beverage intake

• Functional magnetic resonance imaging of the nucleus accumbens

  fMRI measurements between 8 and 20 minutes after start of beverage intake

Study Arms (4)

water 22, water 0, glucose 0, glucose 22

EXPERIMENTAL

Subjects consume 300 ml water at 22 ºC, 300 ml water at 0 ºC, 300 ml water at 0 ºC containing 75 grams glucose and 300 ml water at 22 ºC containing 75 grams glucose sequentially with a one-week washout between consumptions

Other: water 0; Other: water 22; Other: Glucose 0; Other: Glucose 22

water 0, glucose 22, water 22, glucose 0

EXPERIMENTAL

Subjects consume 300 ml water at 0 ºC, 300 ml water at 22 ºC containing 75 grams glucose, 300 ml water at 22 ºC and 300 ml water at 0 ºC containing 75 grams glucose sequentially with a one-week washout between consumptions

Other: water 0; Other: water 22; Other: Glucose 0; Other: Glucose 22

glucose 22, glucose 0, water 0, water 22

EXPERIMENTAL

Subjects consume 300 ml water at 22ºC containing 75 grams glucose, 300 ml water at 0 ºC containing 75 grams glucose, 300 ml water at 0 ºC and 300 ml water at 22 ºC sequentially with a one-week washout between consumptions

Other: water 0; Other: water 22; Other: Glucose 0; Other: Glucose 22

glucose 0, water 22, glucose 22, water 0

EXPERIMENTAL

Subjects consume 300 ml water at 0 ºC containing 75 grams glucose, 300 ml water at 22 ºC, 300 ml water at 22 ºC containing 75 grams glucose and 300 ml water at 0 ºC sequentially with a one-week washout between consumptions

Other: water 0; Other: water 22; Other: Glucose 0; Other: Glucose 22

Interventions

water 0 OTHER

300 ml tap water at 0 ºC

glucose 0, water 22, glucose 22, water 0; glucose 22, glucose 0, water 0, water 22; water 0, glucose 22, water 22, glucose 0; water 22, water 0, glucose 0, glucose 22

water 22 OTHER

300 ml tap water at 22 ºC

glucose 0, water 22, glucose 22, water 0; glucose 22, glucose 0, water 0, water 22; water 0, glucose 22, water 22, glucose 0; water 22, water 0, glucose 0, glucose 22

Glucose 0 OTHER

300 ml tap water at 0 ºC with 75 grams of glucose added

glucose 0, water 22, glucose 22, water 0; glucose 22, glucose 0, water 0, water 22; water 0, glucose 22, water 22, glucose 0; water 22, water 0, glucose 0, glucose 22

Glucose 22 OTHER

300 ml tap water at 22 ºC with 75 grams of glucose added

glucose 0, water 22, glucose 22, water 0; glucose 22, glucose 0, water 0, water 22; water 0, glucose 22, water 22, glucose 0; water 22, water 0, glucose 0, glucose 22

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent
• Age between 18 and 25 years
• BMI between 20 and 23 kg/m2
• Length between 170 and 190 centimetres

You may not qualify if:

• 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 loose 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 2 or more biomedical research projects in one year

Sponsors & Collaborators

• Unilever R&D: lead
• Leiden University Medical Center: collaborator

Study Sites (1)

Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

Location

Related Publications (1)

• van Opstal AM, van den Berg-Huysmans AA, Hoeksma M, Blonk C, Pijl H, Rombouts SARB, van der Grond J. The effect of consumption temperature on the homeostatic and hedonic responses to glucose ingestion in the hypothalamus and the reward system. Am J Clin Nutr. 2018 Jan 1;107(1):20-25. doi: 10.1093/ajcn/nqx023.

  PMID: 29381802 DERIVED

Study Officials

• Jeroen van der Grond

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Study Start: January 28, 2013
• Primary Completion: May 23, 2013
• Study Completion: May 23, 2013
• Last Updated: June 9, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)