Appetite RegulationNCT01644539
Brain Activity and Hormonal Changes During Food Administration
A study testing Water with guar gum - Non Caloric, Chocolate milk - Oral Caloric and Chocolate milk - Intra Gastric Caloric in people with Appetite Regulation, run by UMC Utrecht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Appetite Regulation
- What is being tested?
- Water with guar gum - Non Caloric, Chocolate milk - Oral Caloric and Chocolate milk - Intra Gastric Caloric
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional MRI of Satiety, the Interaction Between Gastric and Oral Stimulation and Related Hormones in Healthy Men
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.
Read the detailed description
Study procedures
- Screening: Before inclusion in the study, potential subjects will complete a screening questionnaire Subjects will then be informed about their eligibility. Also the procedure and risks will be explained. If they decide to participate, they will fill in and sign the standard MRI-screening form and the informed consent form. Also a training session date will be planed.
- Training session: When subjects want to participate and match to the criteria a training session will be planned. During this training session a naso-gastric tube will be inserted by a qualified nurse (according to the "maagsonde-protocol" UMC Utrecht). After insertion of the tube subjects rest to allow water used to assist insertion of the tube to leave the stomach and to become comfortable with the tube. During this insertion the nurse and the subject can see if a subject can handle the naso-gastric tube and can or will participate in the study. Subjects will rate hunger, fullness, thirst, desire to eat, prospective consumption, nauseous, and anxiety on a VAS scale. To simulate the position in the MR scanner, subjects will be asked to lie down on a doctors table. A towel will be placed under need there right side, in this way the stomach will be more in the position when standing/sitting, this is to simulate normal gastric filling. A tube will be placed between the teeth of the subject (like a straw) after which an oral load of 500 ml will be ingested through the tube in the month. This ingestion will be driven by a pomp (100ml/min), which simulates a sip systematically. First 200 ml will be ingested, then there will be a pause of 30 seconds, second the next 150 ml will be pumped, following again a 30 second rest period, then the last 150 ml will be ingested. The subjects know the rate and speed of the sips and can stop the pomp on command when necessary. The subject will also hear a tone just before the sip is ingested. Here a subject learns to drink with a naso-gastric tube placed and when lying down. After ingestion the subjects will fill in the same questionnaire again. The naso-gastric tube will be removed after the rating. This training session will take about 40 minutes.
- Assessments and procedures on the study days: All subjects will be asked to arrive in the morning after an overnight fast of at least 10 hours. The evening before the scan subjects will be ask to eat a standardized meal given by the researchers (AH kant \& klaar). An appetite questionnaire will be filled in (hunger, fullness, thirst, desire to eat, quantity to eat, desire to eat something sweet or savory, nauseous, and anxiety). An intravenous cannula will be placed by a qualified person. Next, the naso-gastric tube will be placed (same procedure as training session). After the subject has been placed in the scanner (as in the training session with a towel under need there right side); one blood draw will be done for baseline measurements (e.g. glucose, insulin, cholecystokinin and ghrelin for every time point). The appetite questionnaire will be filled in again in the scanner. A reference and anatomic scan will be done. Now the fmri session begins; after five minutes of baseline scanning, food administration will start (t = 0). This consists of administration of the intra gastric load through the naso-gastric tube (caloric or non-caloric) or of ingestion of the caloric load through a tube (oral). Blood will be drawn at t = 2.5, t = 5, t = 10, t = 15 and at t = 30 min. Before every blood sample subjects will give fullness and nausea ratings. One of the researchers will stand next to the subject/scanner during the whole experiment. If aspiration occurs a researcher will be there to help immediately. The researchers also make sure a subject knows how to get out of the scanner as quick as possible if aspiration occurs. At t = 30 min the subject will be taken out the scanner and fill in the appetite questionnaire. The naso-gastric tube and intravenous cannula will be removed. Subsequently subjects will be provided with an ad libitum breakfast buffet at t = 45 min. Food weight and macro-nutrient intake will be recorded. After breakfast the appetite questionnaire is filled in once more.
- Blood sampling and storage: On the study day, a 10 ml blood sample will be drawn by certified experienced medical personnel. Blood samples will be put on ice immediately and then centrifuged at 1730 × g for 10 min at 4 ˚C. Blood material from the collection tubes will be split into two portions and stored, one portion for the analyses and one portion as a backup. Blood serum will be stored at -80 ˚C at the Rudolf Magnus Institute until sample collection is complete. Only RMI laboratory personnel and the investigators will have access to the samples. Blood samples will be coded as follows: P01, P02, etc. The key to this code will only be known by the principal and medical investigators and not by the personnel performing the blood analyses. Samples will be kept for 10 years and then destroyed.
- Naso-gastric tube: A qualified nurse will place the naso-gastric tube. The placement will go according to the 'maagsonde -protocol' (UMC Utrecht). After insertion of the tube subjects rest to allow water used to assist insertion of the tube to leave the stomach and to become comfortable with the tube.
- Withdrawal of individual subjects: Subjects can leave the study at any time for any reason if they wish to do so without any consequences. The investigator can decide to withdraw a subject from the study for urgent medical reasons. Each subject who does not complete the study for any reason will have a post-study screening by the end of the particular study day to ensure that the drop-out is not the result of a structural problem. Data of subjects who withdrew prematurely will be used for statistical analyses, as far as possible.
- Replacement of individual subjects after withdrawal: In case subjects withdraw during the study (fMRI sessions), they will not be replaced. If a subject decides not to participate during the training session a new subject will be recruited.
- Follow-up of subjects withdrawn from treatment: Subjects who withdraw from the study will not be followed up, unless they withdraw because of an adverse event.
- Post-study screening: Subjects will be asked how they experienced the study procedures. This information, if the subject is willing to share it, will be used to evaluate (the burden of) the study protocol.
- Conditions
- Appetite Regulation
- Being tested
- Water with guar gum - Non Caloric, Chocolate milk - Oral Caloric, Chocolate milk - Intra Gastric Caloric
- Keywords
- Satiation, Brain activation, Gut peptides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water with guar gum - Non CaloricDietary supplement
Also called Guar gum has the E number E412 and is allowed in the EU
Infusion 500 ml of water with 3 gram of guar gum through a naso-gastric tube directly into stomach during a fMRI scan.
Chocolate milk - Oral CaloricDietary supplement
Also called Chocomel®, FrieslandCampina, Ede, the Netherlands
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.
Chocolate milk - Intra Gastric CaloricDietary supplement
Also called Chocomel®, FrieslandCampina, Ede, the Netherlands
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Chocolate milk - Intra Gastric Caloric |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: -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.
Measured: 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.
Measured: t = 0, 2.5, 5, 10, 15 and 30 minutes
Secondary outcomes (2)
Energy intake (kJ) from the breakfast
Amount of breakfast eaten after treatment
Measured: at t = 45 min
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).
Measured: 5 to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Appetite RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul A.M. Smeets, UMC Utrecht
- Investigators
- Paul AM Smeets, Dr, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644539
- Sponsor's protocol ID
- NL 35991.041.11
- Status last verified
- May 2017
- First submitted
- 12 Jul 2012
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24614074
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional MRI of Satiety, the Interaction Between Gastric and Oral Stimulation and Related Hormones in Healthy Men
- ClinicalTrials.gov ID
- NCT01644539
- Acronym / sponsor ID
- NL 35991.041.11
- Conditions
- Appetite Regulation
- Keywords
- Satiation, Brain activation, Gut peptides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study procedures
- Screening: Before inclusion in the study, potential subjects will complete a screening questionnaire Subjects will then be informed about their eligibility. Also the procedure and risks will be explained. If they decide to participate, they will fill in and sign the standard MRI-screening form and the informed consent form. Also a training session date will be planed.
- Training session: When subjects want to participate and match to the criteria a training session will be planned. During this training session a naso-gastric tube will be inserted by a qualified nurse (according to the "maagsonde-protocol" UMC Utrecht). After insertion of the tube subjects rest to allow water used to assist insertion of the tube to leave the stomach and to become comfortable with the tube. During this insertion the nurse and the subject can see if a subject can handle the naso-gastric tube and can or will participate in the study. Subjects will rate hunger, fullness, thirst, desire to eat, prospective consumption, nauseous, and anxiety on a VAS scale. To simulate the position in the MR scanner, subjects will be asked to lie down on a doctors table. A towel will be placed under need there right side, in this way the stomach will be more in the position when standing/sitting, this is to simulate normal gastric filling. A tube will be placed between the teeth of the subject (like a straw) after which an oral load of 500 ml will be ingested through the tube in the month. This ingestion will be driven by a pomp (100ml/min), which simulates a sip systematically. First 200 ml will be ingested, then there will be a pause of 30 seconds, second the next 150 ml will be pumped, following again a 30 second rest period, then the last 150 ml will be ingested. The subjects know the rate and speed of the sips and can stop the pomp on command when necessary. The subject will also hear a tone just before the sip is ingested. Here a subject learns to drink with a naso-gastric tube placed and when lying down. After ingestion the subjects will fill in the same questionnaire again. The naso-gastric tube will be removed after the rating. This training session will take about 40 minutes.
- Assessments and procedures on the study days: All subjects will be asked to arrive in the morning after an overnight fast of at least 10 hours. The evening before the scan subjects will be ask to eat a standardized meal given by the researchers (AH kant \& klaar). An appetite questionnaire will be filled in (hunger, fullness, thirst, desire to eat, quantity to eat, desire to eat something sweet or savory, nauseous, and anxiety). An intravenous cannula will be placed by a qualified person. Next, the naso-gastric tube will be placed (same procedure as training session). After the subject has been placed in the scanner (as in the training session with a towel under need there right side); one blood draw will be done for baseline measurements (e.g. glucose, insulin, cholecystokinin and ghrelin for every time point). The appetite questionnaire will be filled in again in the scanner. A reference and anatomic scan will be done. Now the fmri session begins; after five minutes of baseline scanning, food administration will start (t = 0). This consists of administration of the intra gastric load through the naso-gastric tube (caloric or non-caloric) or of ingestion of the caloric load through a tube (oral). Blood will be drawn at t = 2.5, t = 5, t = 10, t = 15 and at t = 30 min. Before every blood sample subjects will give fullness and nausea ratings. One of the researchers will stand next to the subject/scanner during the whole experiment. If aspiration occurs a researcher will be there to help immediately. The researchers also make sure a subject knows how to get out of the scanner as quick as possible if aspiration occurs. At t = 30 min the subject will be taken out the scanner and fill in the appetite questionnaire. The naso-gastric tube and intravenous cannula will be removed. Subsequently subjects will be provided with an ad libitum breakfast buffet at t = 45 min. Food weight and macro-nutrient intake will be recorded. After breakfast the appetite questionnaire is filled in once more.
- Blood sampling and storage: On the study day, a 10 ml blood sample will be drawn by certified experienced medical personnel. Blood samples will be put on ice immediately and then centrifuged at 1730 × g for 10 min at 4 ˚C. Blood material from the collection tubes will be split into two portions and stored, one portion for the analyses and one portion as a backup. Blood serum will be stored at -80 ˚C at the Rudolf Magnus Institute until sample collection is complete. Only RMI laboratory personnel and the investigators will have access to the samples. Blood samples will be coded as follows: P01, P02, etc. The key to this code will only be known by the principal and medical investigators and not by the personnel performing the blood analyses. Samples will be kept for 10 years and then destroyed.
- Naso-gastric tube: A qualified nurse will place the naso-gastric tube. The placement will go according to the 'maagsonde -protocol' (UMC Utrecht). After insertion of the tube subjects rest to allow water used to assist insertion of the tube to leave the stomach and to become comfortable with the tube.
- Withdrawal of individual subjects: Subjects can leave the study at any time for any reason if they wish to do so without any consequences. The investigator can decide to withdraw a subject from the study for urgent medical reasons. Each subject who does not complete the study for any reason will have a post-study screening by the end of the particular study day to ensure that the drop-out is not the result of a structural problem. Data of subjects who withdrew prematurely will be used for statistical analyses, as far as possible.
- Replacement of individual subjects after withdrawal: In case subjects withdraw during the study (fMRI sessions), they will not be replaced. If a subject decides not to participate during the training session a new subject will be recruited.
- Follow-up of subjects withdrawn from treatment: Subjects who withdraw from the study will not be followed up, unless they withdraw because of an adverse event.
- Post-study screening: Subjects will be asked how they experienced the study procedures. This information, if the subject is willing to share it, will be used to evaluate (the burden of) the study protocol.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Dietary Supplement: Water with guar gum - Non CaloricSubjects 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. |
| Oral ingestion | Other | Dietary Supplement: Chocolate milk - Oral CaloricSubjects 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. |
| Intra Gastric | Other | Dietary Supplement: Chocolate milk - Intra Gastric CaloricSubjects 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- Smoking
- Slimming or medically prescribed diet
- Restrained eating
- Having an eating disorder
- Having a history of or current alcohol consumption > 28 units per week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water with guar gum - Non CaloricAlso: Guar gum has the E number E412 and is allowed in the EUInfusion 500 ml of water with 3 gram of guar gum through a naso-gastric tube directly into stomach during a fMRI scan. | Dietary supplement | Control |
| Chocolate milk - Oral CaloricAlso: Chocomel®, FrieslandCampina, Ede, the NetherlandsIngestion 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. | Dietary supplement | Oral ingestion |
| Chocolate milk - Intra Gastric CaloricAlso: Chocomel®, FrieslandCampina, Ede, the NetherlandsInfusion 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. | Dietary supplement | Intra Gastric |
Primary outcome
Changes from baseline (when hungry) in brain activation during food infusion.
Time frame: -5 tot 0 min and 0 to 5 min
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.
Area under the curve of serum concentrations of hormones at a time frame of 30 minutes during and after food administration.
Time frame: t = 0, 2.5, 5, 10, 15, and 30 minutes
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.
Area under the curve in appetite ratings at a time frame of 30 min, as an effect of food administration.
Time frame: t = 0, 2.5, 5, 10, 15 and 30 minutes
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.
2 secondary outcomes
Energy intake (kJ) from the breakfast
Time frame: at t = 45 min
Changes from baseline in brain activity after food administration
Time frame: 5 to 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Derived from this study: PubMed 24614074Spetter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul AM Smeets, Dr principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water with guar gum - Non Caloric, Chocolate milk - Oral Caloric and Chocolate milk - Intra Gastric Caloric in people with Appetite Regulation, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline (when hungry) in brain activation during food infusion. (time frame: -5 tot 0 min and 0 to 5 min). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01644539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.