The Effect of Different Macronutrients on Ileal Brake Activation
1 other identifier
interventional
15
1 country
1
Brief Summary
The purpose of this study is to determine whether ileal infusion of casein and sucrose can activate the ileal brake.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2011
CompletedFirst Posted
Study publicly available on registry
January 13, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJanuary 29, 2014
January 1, 2014
1.3 years
August 9, 2011
January 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in satiation (as measured by VAS) and food intake as measured during an ad libitum meal
1 day
Secondary Outcomes (6)
Measurements in plasma and/or platelet poor plasma Plasma levels of the gut hormone Cholecystokinin (CCK)
1 day
Gastric emptying by using the C13 stable isotope breath test
1 day
Small bowel transit time by using lactulose hydrogen breath test
1 day
Gallbladder volumes by gallbladder ultrasound
1 day
Measurements in plasma and/or platelet poor plasma Plasma levels of the gut hormone Glucagon Like Peptide-1 (GLP-1)
1 day
- +1 more secondary outcomes
Study Arms (6)
Low dose casein
EXPERIMENTALIleal infusion of low dose casein
High dose casein
EXPERIMENTALIleal infusion of high dose casein
Low dose sucrose
EXPERIMENTALIleal infusion of low dose sucrose
High dose sucrose
EXPERIMENTALIleal infusion of high dose sucrose
Placebo
PLACEBO COMPARATORIleal infusion saline
Safflower oil
ACTIVE COMPARATORIleal infusion safflower oil
Interventions
Ileal infusion with safflower oil (6gr safflower oil in water)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Related Publications (1)
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.
PMID: 26872548DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
A. Masclee, Prof.
Maastricht University Medical Centre +
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 9, 2011
First Posted
January 13, 2012
Study Start
March 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
January 29, 2014
Record last verified: 2014-01