Is metabolic health in humans related to gut permeability?

Completed

Conditions: metabole gezondheid, (voorstadia) metabool syndroom
gut permeability
'leaky gut'
10017943

Registration Number: NL-OMON43291

Lead Sponsor: Suntory Global Innovation Center Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- Apparently healthy (not meeting any of the exclusion criteria)
- Age range between 20-70 years old
- Men and women
- Highest and lowest values for 1) waist circumference, 2) fasting glucose, 3) (HDL-) cholesterol; assessed during screening procedure.

Exclusion Criteria

- Gastrointestinal disorders (stomach ulcer, ulcerative colitis, Crohn*s disease, celiac disease)
- History of gastrointestinal surgery
- Liver dysfunction (cirrhosis, hepatitis)
- Diabetes mellitus
- History of acute coronary syndrome
- Heart failure
- Kidney dysfunction (eGFR<60ml/min)
- Thromboembolic disorders
- 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 MS mix
- Pregnancy (will not be tested within the Permeable study)
- Age below 20 or over 70 years
- Alcohol intake * 40g/day (* 3-4 glasses of beer/wine per day)
- Drug abuse
- Current smokers
- Participation in other clinical trials in the past month.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is gut permeability assessed by a MS permeability<br /><br>test. In this test, gut permeability is reflected by the urinary excretion<br /><br>levels of sucrose, lactulose, rhamnose, sucralose and erythritol. These sugars<br /><br>are measured in 3 urine fractions that are collected during 24 hours after<br /><br>consumption of a MS mix solution containing these five sugars. Gut permeability<br /><br>will be compared between metabolic healthier and metabolic unhealthier<br /><br>subjects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are fasting state levels of leaky gut biomarkers (LPS,<br /><br>LBP, sCD14, zonulin and leptin) and metabolic health parameters (waist, BMI,<br /><br>HbA1c, glucose, LDL cholesterol, HDL cholesterol, total cholesterol, total<br /><br>triglycerides, ALT, GGT and CRP). These parameters will be compared between<br /><br>metabolic healthier and metabolic unhealthier subjects and correlated with gut<br /><br>permeability as assessed by the MS permeability test.</p><br>