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Measurement of gut permeability in healthy people with a different metabolic profile.


- candidate number24295
- NTR NumberNTR5943
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-apr-2016
- Secondary IDsNL57555.081.16 
- Public TitleMeasurement of gut permeability in healthy people with a different metabolic profile.
- Scientific TitleIs metabolic health in humans related to gut permeability?
- ACRONYM
- hypothesisThere is growing evidence that gut permeability (or a 'leaky gut') can be linked to metabolic health and might therefore be involved in development of metabolic disorders related to the metabolic syndrome. We hypothesize that gut permeability is related to metabolic health.
- Healt Condition(s) or Problem(s) studiedMetabolic health
- Inclusion criteria-Apparently healthy
-Age range between 20-70 years old (the two groups should be age balanced as much as possible)
-Men and women (the two groups should be gender balanced as much as possible)
-Highest and lowest values for 1) waist circumference, 2) fasting glucose, 3) (HDL-) cholesterol
- Exclusion criteria-Gastrointestinal disorders (stomach ulcer, ulcerative colitis, Crohn¡¯s disease, celiac disease)
-History of gastrointestinal surgery
-History of liver dysfunction (cirrhosis, hepatitis)
-Diabetes mellitus
-History of heart attack
-Heart failure
-Kidney dysfunction
-Intake of medications known to change the inflammatory status (i.e proton pump inhibitors, antibiotic, anti-inflammatory medication (including NSAIDs)
-Hypersensitivity to NSAIDs or the sugars in the multi-sugar mix solution
-Pregnancy
-Age below 20 or over 70 years
-Alcohol intake ¡Ý 3-4 glasses of beer/wine per day
-Drug abuse
-Current smokers
-Participation in other clinical trials in the past month
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jul-2016
- planned closingdate14-okt-2016
- Target number of participants30
- InterventionsNo intervention
- Primary outcomeThe main study parameter is gut permeability assessed by a MS permeability test. In this test, gut permeability is reflected by the urinary excretion levels of sucrose, lactulose, rhamnose, sucralose and erythritol. These sugars are measured in 3 urine fractions that are collected during 24 hours after consumption of a MS mix solution containing these five sugars. Gut permeability will be compared between metabolic healthier and metabolic unhealthier subjects.
- Secondary outcomeSecondary parameters are fasting state levels of leaky gut biomarkers (LPS, LBP, sCD14, zonulin and leptin) and metabolic health parameters (waist, BMI, HbA1c, glucose, LDL cholesterol, HDL cholesterol, total cholesterol, total triglycerides, ALT, GGT and CRP). These parameters will be compared between metabolic healthier and metabolic unhealthier subjects and correlated with gut permeability as assessed by the MS permeability test.
- TimepointsThe gut permeability test will be assessed twice, once without and once with an aspirin challenge prior to the test.
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES Judith v/d Horst-Graat
- CONTACT for SCIENTIFIC QUERIESPhD Nicole de Wit
- Sponsor/Initiator Stichting Dienst Landbouwkundig Onderzoek, Wageningen University (WUR)
- Funding
(Source(s) of Monetary or Material Support)
Suntory Global Innovation Center Limited, Japan
- Publications
- Brief summaryThere is growing evidence that gut permeability (or a ‘leaky gut’) can be linked to metabolic health and might therefore be involved in development of metabolic disorders related to the metabolic syndrome. In the Permeable study, we want to expand our knowledge on if and how the intestinal barrier relates to metabolic health. This knowledge could be fundamental to further identify and explore compounds that can strengthen the intestinal barrier and thereby contribute to metabolic health and the prevention of metabolic disorders.

The objective of the study is to compare gut permeability in metabolic healthier and metabolic unhealthier subjects by performing a multi-sugar (MS) permeability test and determine the correlation between gut permeability and metabolic health status.

The Permeable study is an observational study, in which gut permeability is assessed by a MS permeability test, with and without an acetylsalicylic acid challenge. On the day of the MS test, first a fasting blood sample is collected. Subsequently, subjects consume 200 ml MS mix solution (containing sucrose, lactulose, rhamnose, sucralose and erythritol) and urine is collected in three fractions (0-2 hours, 2-5 hours and 5-24 hours). During the second visit, the same procedures are repeated, except the subjects will consume acetylsalicylic acid before the MS test (1000mg in the evening and 1000mg in morning prior to the test).

The study will be performed with apparently healthy adult volunteers, age between 20-70 years old. Based on waist circumference, fasting glucose and HDL cholesterol, two groups (n=15 per group) differing in metabolic health (metabolic healthier and metabolic unhealthier) will be selected to participate in the study.
- Main changes (audit trail)
- RECORD25-apr-2016 - 23-aug-2016


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