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Effect of total parenteral feeding on the postprandial bile acid response

Completed
Conditions
total parenteral nutritrion
10019654
10018424
Registration Number
NL-OMON44354
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
8
Inclusion Criteria

- Ability to provide informed consent
- 18 years or older at the time of signing the informed consent
- Body mass index (BMI) 18.5- 25 kg/m2
- Caucasian men
- General good health as determined by medical history, physical examination and blood chemistry by a physician.
-HOMA-IR index: * 2.0 (measured as fasting insulin (pmol/L) x fasting glucose (mmol/L) / 135)

Exclusion Criteria

-Major illness in the past 3 months
-Use of any medication
-Gastro-intestinal disease that may influence bile acid metabolism
-History of cholecystectomy or other bile duct abnormalities
-Tobacco smoking
-Drugs abuse
-Alcoholism (>3 units a day)
-Allergy or intolerance to ingredients included in the standardized meals
-Blood chemistry:
*Creatinine >120 µM
*>2 times upper limit reference interval of the following: ASAT, ALAT, bilirubin, GGT and AF.
*Lipid spectrum
-Strenuous exercise for at least 3 days prior to each study day, defined as more than 1 hour of exercise per day.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>To assess the effect of a parenteral MMT compared to an enteral MMT on<br /><br>* Postprandial bile acid signalling metabolism<br /><br>* Postprandial inflammatory responses </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>1. To assess the effect of a parenteral MMT compared to an enteral MMT on<br /><br>* Glucoregulatory and gut hormones<br /><br>* Lipid profiles<br /><br>* Resting energy expenditure<br /><br>* Appetite and satiety<br /><br>* Blood pressure<br /><br>* Body core temperature<br /><br><br /><br>2. Assess the correlation between the microbiota composition and postprandial<br /><br>bile acid signalling. </p><br>
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