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Effect of total parenteral feeding on the postprandial bile acid response

Effect of total parenteral feeding on the postprandial bile acid response - TRENT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44354
Enrollment
8
Registered
2017-11-24
Start date
2018-01-11
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

total parenteral nutritrion

Interventions

Subjects will undergo an enteral and a parenteral mixed meal test (MMTs) on different days in random order. The mixed meal test will be performed using Olimel Perifeer N4E (Baxter B.V. Utrecht, The

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
To assess the effect of a parenteral MMT compared to an enteral MMT on * Postprandial bile acid signalling metabolism * Postprandial inflammatory responses

Secondary

MeasureTime frame
1. To assess the effect of a parenteral MMT compared to an enteral MMT on * Glucoregulatory and gut hormones * Lipid profiles * Resting energy expenditure * Appetite and satiety * Blood pressure * Body core temperature 2. Assess the correlation between the microbiota composition and postprandial bile acid signalling.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)