Appetite Regulation Clinical Trial
Official title:
Functional MRI of Satiety, the Interaction Between Gastric and Oral Stimulation and Related Hormones in Healthy Men
Verified date | May 2017 |
Source | UMC Utrecht |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The amount and kind of food which is ingested influences the regulation of meal size. Neural signals from the gastrointestinal tract travel via the vagus nerve to the brainstem and thalamus, which projects to the rest of the brain, in particular the hypothalamus, amygdala and primary sensory cortices. In neuroimaging studies in which the stomach was distended with a gastric balloon activation was observed in the right insula, left posterior amygdala, left posterior insula, left inferior frontal gyrus and anterior cingulate cortex. So far, no study has examined the effects of the ingestion or infusion of a food on the brain. In addition to neural signals, hormonal signals are important for meal termination. Hormones like insulin, ghrelin and cholecystokinin interact with gastric as well as sensory signals in the process of satiation, which ultimately leads to meal termination. The aim of this study is to investigate the interaction between food administration, hormone responses and brain responses. To this end an oral or intra-gastric load will be administered while measuring brain activity (functional magnetic resonance imaging) and hormone concentrations. Subjects will participate in one trainings session and in three functional magnetic resonance imaging (fMRI) sessions (35-min fMRI scan). A training session will take 40-minutes and consists of placing a naso-gastric tube and ingesting 500 ml of chocolate milk orally. The fMRI sessions will consist of three conditions: in condition one (A) 500ml of chocolate milk will be administrated orally. In condition two (B) and three (C) an intra-gastric load of 500 ml is administrated.
Status | Completed |
Enrollment | 16 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: 1. Healthy (self-reported) 2. Males with age 18 and 35 year at day 01 of the study 3. Body Mass Index (BMI) between 20 and 25 kg/m2 4. Right-handed 5. Voluntary participation 6. Having given their written informed consent 7. Willing to comply with the study procedures 8. Willing to accept use of all anonymized data, including publication, and the confidential use and storage of all data 9. Willing to be informed about chance findings of pathology and approving of the disclosure of this information to the general physician (see Informed Consent) 10. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned (Belastingdienst) Exclusion Criteria: 1. Smoking 2. Slimming or medically prescribed diet 3. Restrained eating 4. Having an eating disorder 5. Having a history of or current alcohol consumption > 28 units per week 6. Having a history of medical or surgical events that may significantly affect the study outcome, such as metabolic or endocrine disease, or any gastro-intestinal disorder 7. Use of medication, except aspirin/paracetamol 8. Claustrophobia 9. Having a taste or smell disorder or any neurological or psychiatric disorder 10. Having metal implants (i.e. pacemaker, metal joints, prostheses, etc.) or metal objects on the body which cannot be removed (i.e. piercing, hearing aid, brace, etc.) 11. Mental or physical status that is incompatible with the proper conduct of the study 12. Not having a general practitioner 13. Participation in any other clinical trial during this study. 14. Working at the Image Sciences Institute or the Radiology Department of the UMC Utrecht as employee or student. |
Country | Name | City | State |
---|---|---|---|
Netherlands | UMC Utrecht - division Beeld | Utrecht |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from baseline (when hungry) in brain activation during food infusion. | Brian activity is measured (fmri) non-stop. First 5 minutes refers to the baseline measurement (-5 - 0 min). Then food infusion starts (0 - 5 min). The differences in brain activation between the 5 min fmri measurement during baseline and food infusion is the main outcome. | -5 tot 0 min and 0 to 5 min | |
Primary | Area under the curve of serum concentrations of hormones at a time frame of 30 minutes during and after food administration. | Change from baseline (t = 0; when hungry) in hormonal concentrations (glucose, insulin, cholecystokinin, ghrelin) during (0 - 5 min) and after (5 - 30 min) food administration. Measured at five time-points in 30 min. | t = 0, 2.5, 5, 10, 15, and 30 minutes | |
Primary | Area under the curve in appetite ratings at a time frame of 30 min, as an effect of food administration. | Changes from baseline (t = 0; when hungry) in fullness, desire to eat and anxiety ratings during (0 - 5 min) and after (5 - 30 min) food administration. Measured at five time-points in 30 min. | t = 0, 2.5, 5, 10, 15 and 30 minutes | |
Secondary | Energy intake (kJ) from the breakfast | Amount of breakfast eaten after treatment | at t = 45 min | |
Secondary | Changes from baseline in brain activity after food administration | After food administration brain activity was measured non-stop for 25 minutes. Activation in brain areas in this time frame were compared to baseline (when hungry). | 5 to 30 minutes |
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