Brain Activity and Hormonal Changes During Food Administration

NCT01644539 | Completed

• 1 other identifier: NL 35991.041.11
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Appetite Regulation

Keywords

Satiation; Brain activation; Gut peptides

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Energy intake (kJ) from the breakfast

  at t = 45 min

• Changes from baseline in brain activity after food administration

  5 to 30 minutes

Study Arms (3)

Control

OTHER

Subjects participated in a 35 min fmri scan. Intervention: intra-gastric infusion of 500 ml non caloric load consisting of water and thickening agent (guar gum), over 5 min. While scanning: -5 - 0 min : baseline scan 0 - 5 min: intra-gastric infusion (naso-gastric tube) of 500 ml non caloric load consisting of water and thickening agent (guar gum) in a time frame of 5 minutes while being scanned (fmri) 5 - 30 min: fmri scan continues while subject lays still At t = 0, 2.5, 5, 10, 15 and 30 blood will be drawn and appetite ratings will be given.

Dietary Supplement: Water with guar gum - Non Caloric

Oral ingestion

OTHER

Subjects participated in a 35 min fmri scan. Intervention: Oral ingestion (through a tube, while drinking and swallowing on command) of 500 ml caloric load consisting of Nutricia Chocolate Milk, over 5 min. Time frame while scanning: -5 - 0 min : baseline fmri scan 0 - 5 min: oral ingestion (through a tube, while drinking and swallowing on command) of 500 ml caloric load consisting of Nutricia Chocolate Milk in a time frame of 5 minutes while being scanned (fmri) 5 - 30 min: fmri scan continues while subject lays still At t = 0, 2.5, 5, 10, 15 and 30 blood will be drawn and appetite ratings will be given.

Dietary Supplement: Chocolate milk - Oral Caloric

Intra Gastric

OTHER

Subjects participated in a 35 min fmri scan. Intervention: intra-gastric infusion (naso-gastric tube) of 500 ml caloric load consisting of Nutricia Cholate Milk, over 5 min. While scanning: -5 - 0 min : baseline scan 0 - 5 min: intra-gastric infusion (naso-gastric tube) of 500 ml caloric load consisting of Nutricia Cholate Milk in a time frame of 5 minutes while being scanned (fmri) 5 - 30 min: fmri scan continues while subject lays still At t = 0, 2.5, 5, 10, 15 and 30 blood will be drawn and appetite ratings will be given.

Dietary Supplement: Chocolate milk - Intra Gastric Caloric

Interventions

Water with guar gum - Non Caloric DIETARY_SUPPLEMENT

Infusion 500 ml of water with 3 gram of guar gum through a naso-gastric tube directly into stomach during a fMRI scan.

Also known as: Guar gum has the E number E412 and is allowed in the EU

Control

Chocolate milk - Oral Caloric DIETARY_SUPPLEMENT

Ingestion of 500 ml of commercially available chocolate milk (Per 100mL; energy content of 354 kJ, 84 kcal, 3.5 g proteins, 12 g mono and disaccharide, 2.5 fat g, 0.5 g fibers) through a tube in the mouth during a fmri scan.

Also known as: Chocomel®, FrieslandCampina, Ede, the Netherlands

Oral ingestion

Chocolate milk - Intra Gastric Caloric DIETARY_SUPPLEMENT

Infusion of 500 ml of commercially available chocolate milk (Per 100mL; energy content of 354 kJ, 84 kcal, 3.5 g proteins, 12 g mono and disaccharide, 2.5 fat g, 0.5 g fibers) through a naso-gastric tube directly into stomach during a fMRI scan.

Also known as: Chocomel®, FrieslandCampina, Ede, the Netherlands

Intra Gastric

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy (self-reported)
• Males with age 18 and 35 year at day 01 of the study
• Body Mass Index (BMI) between 20 and 25 kg/m2
• Right-handed
• Voluntary participation
• Having given their written informed consent
• Willing to comply with the study procedures
• Willing to accept use of all anonymized data, including publication, and the confidential use and storage of all data
• Willing to be informed about chance findings of pathology and approving of the disclosure of this information to the general physician (see Informed Consent)
• Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned (Belastingdienst)

You may not qualify if:

• Smoking
• Slimming or medically prescribed diet
• Restrained eating
• Having an eating disorder
• Having a history of or current alcohol consumption \> 28 units per week
• 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
• Use of medication, except aspirin/paracetamol
• Claustrophobia
• Having a taste or smell disorder or any neurological or psychiatric disorder
• 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.)
• Mental or physical status that is incompatible with the proper conduct of the study
• Not having a general practitioner
• Participation in any other clinical trial during this study.
• Working at the Image Sciences Institute or the Radiology Department of the UMC Utrecht as employee or student.

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

UMC Utrecht - division Beeld

Utrecht, 3684 CX, Netherlands

Location

Related Publications (1)

• Spetter MS, de Graaf C, Mars M, Viergever MA, Smeets PA. The sum of its parts--effects of gastric distention, nutrient content and sensory stimulation on brain activation. PLoS One. 2014 Mar 10;9(3):e90872. doi: 10.1371/journal.pone.0090872. eCollection 2014.

  PMID: 24614074 DERIVED

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Paul AM Smeets, Dr

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 19, 2012
• Study Start: July 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

NL (1)