EatingNCT02511366
Repetitive Brake Activation
A study testing Ileal infusion of casein and Ileal infusion of tap water in people with Eating and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The appearance of intact macronutrients in the small intestine induces an intestinal brake; a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating, Obesity, Ileal Brake
- What is being tested?
- Ileal infusion of casein and Ileal infusion of tap water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2015to Nov 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Based on medical history and previous examination, no gastrointestinal complaints can be defined.
- Age between 18 and 65 years. A higher age comes with a higher chance of comorbidities. These could influence our study outcomes and therefore this age range was chosen. Furthermore, we think this study would be too invasive for subjects over the age of 65. This study will include healthy adult subjects (male and female). Women must be taking contraceptives.
- BMI between 18 and 25 kg/m2)
- Weight stable over at least the last 6 months (≤5% weight change)
Who cannot join
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
- Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
- Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
- Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)
- Pregnancy, lactation
Show all 11Show fewer
- Excessive alcohol consumption (>20 alcoholic consumptions per week)
- Smoking
- Blood donation within 3 months before the study period
- Self-admitted HIV-positive state
- Evidence of casein or hypersensitivity
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Maastricht
About this study
Official title: The Effect of Repetitive Ileal Brake Activation on Food Intake, Satiety, Gastrointestinal Peptide Release, Gastric Emptying and Gallbladder Volume
The appearance of intact macronutrients in the small intestine induces an intestinal brake; a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. Several studies showed that intraileal infusion of nutrients resulted in a reduction in food intake. However only acute effects were investigated in these studies and thus far it is not known whether repetitive (intermittent) infusion results in adaptation to repeated exposure and, thus, a lowered ileal brake response.
- Conditions
- Eating, Obesity, Ileal Brake
- Being tested
- Ileal infusion of casein, Ileal infusion of tap water
- Keywords
- ileal brake
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ileal infusion of caseinOther
Intraileal infusion of casein
Ileal infusion of tap waterOther
Also called placebo
Intraileal infusion of tap water
| Study group | Role | What they receive |
|---|---|---|
| ileal infusion of casein | Experimental | Ileal infusion of casein Receives: Other: Ileal infusion of casein |
| ileal infusion of tap water | Placebo comparator | ileal infusion of tap water Receives: Other: Ileal infusion of tap water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum food intake
Ad libitum food intake will be measured in kcal and the end of each test day (4 in total, all within one week)
Measured: 1 Day
Secondary outcomes (9)
Satiety
Visual analogue scale forms for satiety (0-100 mm scale) wil be filled in during each test day (4 in total, all within one week)
Measured: 1 Day
Gastrointestinal peptide release (CCK)
Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)
Measured: 1 Day
Gastrointestinal peptide release (GLP-1)
Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)
Measured: 1 Day
Gastrointestinal peptide release (PYY)
Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)
Measured: 1 Day
Gastrointestinal peptide release (insulin)
Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)
Measured: 1 Day
Gastrointestinal peptide release (glucose)
Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)
Measured: 1 Day
gastric emptying rate
Gastric emptying rate with 13C octanoic acid breath test to determine T1/2
Measured: 1 Day
Gallbladder volume
Gallbladder measurements with ultrasound (volume of GB in mL will be scored)
Measured: 1 Day
Small intestinal transit time
Small intestinal transit time measurements with H2 breath analyser and lactulose
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EatingStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A. Masclee, Prof dr., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511366
- Sponsor's protocol ID
- NL50301.068.14
- Status last verified
- Jul 2015
- First submitted
- 9 Apr 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Repetitive Ileal Brake Activation on Food Intake, Satiety, Gastrointestinal Peptide Release, Gastric Emptying and Gallbladder Volume
- ClinicalTrials.gov ID
- NCT02511366
- Acronym / sponsor ID
- NL50301.068.14
- Conditions
- Eating, Obesity, Ileal Brake
- Keywords
- ileal brake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 30 Jul 2015 (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 appearance of intact macronutrients in the small intestine induces an intestinal brake; a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. Several studies showed that intraileal infusion of nutrients resulted in a reduction in food intake. However only acute effects were investigated in these studies and thus far it is not known whether repetitive (intermittent) infusion results in adaptation to repeated exposure and, thus, a lowered ileal brake response.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ileal infusion of casein | Experimental | Other: Ileal infusion of caseinIleal infusion of casein |
| ileal infusion of tap water | Placebo comparator | Other: Ileal infusion of tap waterileal infusion of tap water |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Based on medical history and previous examination, no gastrointestinal complaints can be defined.
- Age between 18 and 65 years. A higher age comes with a higher chance of comorbidities. These could influence our study outcomes and therefore this age range was chosen. Furthermore, we think this study would be too invasive for subjects over the age of 65. This study will include healthy adult subjects (male and female). Women must be taking contraceptives.
- BMI between 18 and 25 kg/m2)
- Weight stable over at least the last 6 months (≤5% weight change)
Key exclusion criteria (11 listed)
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
- Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
- Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
- Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)
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 |
|---|---|---|
| Ileal infusion of caseinIntraileal infusion of casein | Other | ileal infusion of casein |
| Ileal infusion of tap waterAlso: placeboIntraileal infusion of tap water | Other | ileal infusion of tap water |
Primary outcome
Ad libitum food intake
Time frame: 1 Day
Ad libitum food intake will be measured in kcal and the end of each test day (4 in total, all within one week)
9 secondary outcomes
Satiety
Time frame: 1 Day
Gastrointestinal peptide release (CCK)
Time frame: 1 Day
Gastrointestinal peptide release (GLP-1)
Time frame: 1 Day
Gastrointestinal peptide release (PYY)
Time frame: 1 Day
Gastrointestinal peptide release (insulin)
Time frame: 1 Day
Gastrointestinal peptide release (glucose)
Time frame: 1 Day
gastric emptying rate
Time frame: 1 Day
Gallbladder volume
Time frame: 1 Day
Small intestinal transit time
Time frame: 1 Day
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 3 Nov 2015.
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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.
A. Masclee, Prof dr. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ileal infusion of casein and Ileal infusion of tap water in people with Eating and Obesity, run by Maastricht University Medical Center 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 4 inclusion and 11 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 3 Nov 2015. 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. Some participants in this study may receive a placebo. 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?
Ad libitum food intake (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2015.