NCT03181217: COLD

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

Completed NA Last updated 9 June 2017

What this trial tests

NA trial testing water 0 in Healthy in 16 participants. Completed in 23 May 2013.

Timeline

28 January 2013

Primary endpoint
23 May 2013

23 May 2013

Quick facts

Lead sponsor	Unilever R&D
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	16
Start date	28 January 2013
Primary completion	23 May 2013
Estimated completion	23 May 2013
Sites	1 location across Netherlands

Drugs / interventions tested

• water 0
• water 22
• Glucose 0
• Glucose 22

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Unilever R&D — full company profile →

Who can join

Adults 18 to 25, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The effect of consumption temperature on the homeostatic and hedonic responses to glucose ingestion in the hypothalamus and the reward system.
   van Opstal AM, van den Berg-Huysmans AA, Hoeksma M, Blonk C, et al · · 2018 · cited 15× · PMID 29381802 · DOI 10.1093/ajcn/nqx023