ObesityNCT01509469
The Effect of Different Macronutrients on Ileal Brake Activation
A study testing Casein, Sucrose and Saline in people with Obesity and Overweight, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether ileal infusion of casein and sucrose can activate the ileal brake. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Casein, Sucrose and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2012to Jun 2013
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Based on medical history and previous examination, no gastrointestinal complaints can be defined.
- Age between 18 and 55 years. This study will include healthy adult subjects (Male and Female), Women must be taking oral contraceptives. Subjects over 55 years have an increased risk for comorbidities, therefore, subjects over 55 years will not be included.
- BMI between 18 and 29 kg/m2
- Less then 2 'yes' responses in the SCOFF questionnaire (see appendix F1)
- Weight stable over at least the last 6 months
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 12Show fewer
- Excessive alcohol consumption (>20 alcoholic consumptions per week)
- Smoking
- Blood donation within 3 months before the study period
- Self-admitted HIV-positive state
- Eating disorders detected using the 'SCOFF questionnaire' (in Dutch translation)
- Lactose or cow milk intolerance
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg
About this study
The purpose of this study is to determine whether ileal infusion of casein and sucrose can activate the ileal brake.
Read the detailed description
The appearance of a food matrix into the duodenum, both during a meal and during the postprandial phase results in a feed-back from different parts of the intestine to the stomach, to the small intestine and to the central nervous system. All these processes inhibit, in concert, food processing in the gastrointestinal tract, satiation and appetite sensations and, consequently, food intake. These processes are involved in the so-called intestinal brake. The location at which the feedback process is initiated determines the severity of the brake effect; the entry of nutrients into the duodenum and jejunum activates the so-called duodenal and jejunal "brakes": negative feedback mechanisms that influence the function of more proximal parts of the gastrointestinal tract. Activation of both of these feedback mechanisms results in reduction of food intake and inhibition of hunger, probably partly by inhibition of gastric emptying rate (thus contributing to enhanced and prolonged gastric distension) and small intestinal transit time. More distal in the small intestine, the ileal brake is a feedback mechanism that results in inhibition of proximal gastrointestinal motility and secretion and increase feelings of satiation and reduction of ad libitum food intake.These results all point to a potentially powerful role of the ileal brake in the regulation of digestion, with direct or indirect impact upon eating behaviour and satiation.
The current scientific data strongly suggest that activation of the ileal brake provides the most powerful feedback mechanism to gastrointestinal transit and, especially, satiety signals and food intake. Most studies have used fat as macronutrient. The effects of several amounts, types and preparations of fat on the ileal brake have previously been investigated and reported.
Until present, the effects of the other macronutrients to induce the ileal brake remain largely unknown. There is evidence that carbohydrates induce the ileal brake. Proteins may also exert effects, although data are scarce and not convincing. However, it becomes more and more accepted that proteins may induce stronger effects on satiation and food intake than fat or carbohydrates.
In this study we're going to investigate the effect of intraileal infusion of casein and sucrose on ileal brake activation.
- Conditions
- Obesity, Overweight
- Being tested
- Casein, Sucrose, Saline, Safflower oil
- Keywords
- Ileal brake, Casein, Sucrose, Ileal infusion
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaseinDietary supplement
Ileal infusion of low dose casein (5 gram)
CaseinDietary supplement
Ileal infusion of high dose casein (15 gram)
SucroseDietary supplement
Ileal infusion of low dose sucrose (4.3 gram)
SucroseDietary supplement
Ileal infusion of high dose sucrose (12.9 gram)
SalineOther
Ileal infusion with saline (180mL in total)
Safflower oilDietary supplement
Ileal infusion with safflower oil (6gr safflower oil in water)
| Study group | Role | What they receive |
|---|---|---|
| Low dose casein | Experimental | Ileal infusion of low dose casein Receives: Dietary Supplement: Casein |
| High dose casein | Experimental | Ileal infusion of high dose casein Receives: Dietary Supplement: Casein |
| Low dose sucrose | Experimental | Ileal infusion of low dose sucrose Receives: Dietary Supplement: Sucrose |
| High dose sucrose | Experimental | Ileal infusion of high dose sucrose Receives: Dietary Supplement: Sucrose |
| Placebo | Placebo comparator | Ileal infusion saline Receives: Other: Saline |
| Safflower oil | Active comparator | Ileal infusion safflower oil Receives: Dietary Supplement: Safflower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in satiation (as measured by VAS) and food intake as measured during an ad libitum meal
Measured: 1 day
Secondary outcomes (6)
Measurements in plasma and/or platelet poor plasma Plasma levels of the gut hormone Cholecystokinin (CCK)
Measured: 1 day
Gastric emptying by using the C13 stable isotope breath test
Measured: 1 day
Small bowel transit time by using lactulose hydrogen breath test
Measured: 1 day
Gallbladder volumes by gallbladder ultrasound
Measured: 1 day
Measurements in plasma and/or platelet poor plasma Plasma levels of the gut hormone Glucagon Like Peptide-1 (GLP-1)
Measured: 1 day
Measurements in plasma and/or platelet poor plasma Plasma levels of the gut hormone peptide YY (PYY)
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 posted13 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2013
- Study completionJun 2013
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 ObesityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Responsible party
- Principal investigator, Mark van Avesaat, Maastricht University Medical Center
- Investigators
- A. Masclee, Prof., Principal investigator, Maastricht University Medical Centre +
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509469
- Sponsor's protocol ID
- NL36916.068.11
- Status last verified
- Jan 2014
- First submitted
- 9 Aug 2011
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ripken D, van Avesaat M, Troost FJ, Masclee AA, Witkamp RF, Hendriks HF. Intraileal casein infusion increases plasma concentrations of amino acids in humans: A randomized cross over trial. Clin Nutr. 2017 Feb;36(1):143-149. doi: 10.1016/j.clnu.2016.01.012. Epub 2016 Jan 29.
PubMed 26872548
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Macronutrients on Ileal Brake Activation
- ClinicalTrials.gov ID
- NCT01509469
- Acronym / sponsor ID
- NL36916.068.11
- Conditions
- Obesity, Overweight
- Keywords
- Ileal brake, Casein, Sucrose, Ileal infusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 13 Jan 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 purpose of this study is to determine whether ileal infusion of casein and sucrose can activate the ileal brake.
Detailed description
The appearance of a food matrix into the duodenum, both during a meal and during the postprandial phase results in a feed-back from different parts of the intestine to the stomach, to the small intestine and to the central nervous system. All these processes inhibit, in concert, food processing in the gastrointestinal tract, satiation and appetite sensations and, consequently, food intake. These processes are involved in the so-called intestinal brake. The location at which the feedback process is initiated determines the severity of the brake effect; the entry of nutrients into the duodenum and jejunum activates the so-called duodenal and jejunal "brakes": negative feedback mechanisms that influence the function of more proximal parts of the gastrointestinal tract. Activation of both of these feedback mechanisms results in reduction of food intake and inhibition of hunger, probably partly by inhibition of gastric emptying rate (thus contributing to enhanced and prolonged gastric distension) and small intestinal transit time. More distal in the small intestine, the ileal brake is a feedback mechanism that results in inhibition of proximal gastrointestinal motility and secretion and increase feelings of satiation and reduction of ad libitum food intake.These results all point to a potentially powerful role of the ileal brake in the regulation of digestion, with direct or indirect impact upon eating behaviour and satiation.
The current scientific data strongly suggest that activation of the ileal brake provides the most powerful feedback mechanism to gastrointestinal transit and, especially, satiety signals and food intake. Most studies have used fat as macronutrient. The effects of several amounts, types and preparations of fat on the ileal brake have previously been investigated and reported.
Until present, the effects of the other macronutrients to induce the ileal brake remain largely unknown. There is evidence that carbohydrates induce the ileal brake. Proteins may also exert effects, although data are scarce and not convincing. However, it becomes more and more accepted that proteins may induce stronger effects on satiation and food intake than fat or carbohydrates.
In this study we're going to investigate the effect of intraileal infusion of casein and sucrose on ileal brake activation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Low dose casein | Experimental | Dietary Supplement: CaseinIleal infusion of low dose casein |
| High dose casein | Experimental | Dietary Supplement: CaseinIleal infusion of high dose casein |
| Low dose sucrose | Experimental | Dietary Supplement: SucroseIleal infusion of low dose sucrose |
| High dose sucrose | Experimental | Dietary Supplement: SucroseIleal infusion of high dose sucrose |
| Placebo | Placebo comparator | Other: SalineIleal infusion saline |
| Safflower oil | Active comparator | Dietary Supplement: Safflower oilIleal infusion safflower oil |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Based on medical history and previous examination, no gastrointestinal complaints can be defined.
- Age between 18 and 55 years. This study will include healthy adult subjects (Male and Female), Women must be taking oral contraceptives. Subjects over 55 years have an increased risk for comorbidities, therefore, subjects over 55 years will not be included.
- BMI between 18 and 29 kg/m2
- Less then 2 'yes' responses in the SCOFF questionnaire (see appendix F1)
- Weight stable over at least the last 6 months
Key exclusion criteria (12 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 |
|---|---|---|
| CaseinIleal infusion of low dose casein (5 gram) | Dietary supplement | Low dose casein |
| CaseinIleal infusion of high dose casein (15 gram) | Dietary supplement | High dose casein |
| SucroseIleal infusion of low dose sucrose (4.3 gram) | Dietary supplement | Low dose sucrose |
| SucroseIleal infusion of high dose sucrose (12.9 gram) | Dietary supplement | High dose sucrose |
| SalineIleal infusion with saline (180mL in total) | Other | Placebo |
| Safflower oilIleal infusion with safflower oil (6gr safflower oil in water) | Dietary supplement | Safflower oil |
Primary outcome
Difference in satiation (as measured by VAS) and food intake as measured during an ad libitum meal
Time frame: 1 day
6 secondary outcomes
Measurements in plasma and/or platelet poor plasma Plasma levels of the gut hormone Cholecystokinin (CCK)
Time frame: 1 day
Gastric emptying by using the C13 stable isotope breath test
Time frame: 1 day
Small bowel transit time by using lactulose hydrogen breath test
Time frame: 1 day
Gallbladder volumes by gallbladder ultrasound
Time frame: 1 day
Measurements in plasma and/or platelet poor plasma Plasma levels of the gut hormone Glucagon Like Peptide-1 (GLP-1)
Time frame: 1 day
Measurements in plasma and/or platelet poor plasma Plasma levels of the gut hormone peptide YY (PYY)
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 29 Jan 2014.
- Derived from this study: PubMed 26872548Ripken D, van Avesaat M, Troost FJ, Masclee AA, Witkamp RF, Hendriks HF. Intraileal casein infusion increases plasma concentrations of amino acids in humans: A randomized cross over trial. Clin Nutr. 2017 Feb;36(1):143-149. doi: 10.1016/j.clnu.2016.01.012. Epub 2016 Jan 29.
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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. principal investigator
Maastricht University Medical Centre +
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Casein, Sucrose and Saline in people with Obesity and Overweight, 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 5 inclusion and 12 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 29 Jan 2014. 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?
Difference in satiation (as measured by VAS) and food intake as measured during an ad libitum meal (time frame: 1 day). 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 NCT01509469, 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 29 Jan 2014; AzTrials last refreshed its copy on 6 Nov 2026.