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

Is metabolic health in humans related to gut permeability?

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON20611

Enrollment

Registered

2016-04-25

Start date

2016-07-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic health (waist circumference, BMI, fasting glucose, HbA1c, LDL cholesterol, HDL cholesterol, total cholesterol, total triglycerides, ALT, GGT and hsCRP)

Interventions

No intervention

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The 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.	—

Measure

Time frame

The 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.

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Secondary

Measure	Time frame
Secondary 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.	—

Measure

Time frame

Secondary 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.

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Contacts

Public ContactJudith v/d Horst-Graat

Stichting Dienst Landbouwkundig Onderzoek Wageningen UR Food & Biobased Research Consumer Science & Health

email: judith.vanderhorst@wur.nltel: +31-317-483056

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)