Kinetics of Metabolic Cofactors in NAFLD
Keywords
Abstract
Description
In 10 healthy subjects with BMI <30 kg/m2 the plasma concentrations of 4 natural compounds (nicotinamide riboside, L-carnitine, L-serine and N-acetylcystein) are measured by ultra-performance liquid chromatography-tandem mass spectrometry (UPLCMSMS) after individual and combined administration, on five consecutive days and at every hour during 9 hours after administration. The study will start at 8:00 every morning and at each time point, blood samples will be collected.
The taste and any potential sensing of the co-factors such as vertigo, nausea, bowel movement will be recorded.
Each participant will receive one oral dose of Day 1: 1 g nicotinamide riboside; Day 2: 3 g L-carnitine; Day 3: 5 g N-acetylcystein; Day 4: 20 g L-serine; Day 5: combined 1 g nicotinamide riboside, 3 g L-carnitine, 5 g N-acetylcystein, and 20 g L-serine
In addition, untargeted metabolomics analysis as well as O-link proteomics analysis we be performed to study effect of the administered cofactors.
Dates
| Last Verified: | 01/31/2019 |
| First Submitted: | 02/03/2019 |
| Estimated Enrollment Submitted: | 02/10/2019 |
| First Posted: | 02/11/2019 |
| Last Update Submitted: | 02/11/2019 |
| Last Update Posted: | 02/14/2019 |
| Actual Study Start Date: | 08/31/2018 |
| Estimated Primary Completion Date: | 10/31/2018 |
| Estimated Study Completion Date: | 11/30/2018 |
Condition or disease
Intervention/treatment
Dietary Supplement: Intervention
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Intervention Oral administration of cofactors, 1g nicotinamide riboside, 3g L-carnitine, 20g serine and 5g N-acetylcystein, first as single compounds, then combined, on 5 days | Dietary Supplement: Intervention Oral administration of 1g nicotinamide riboside, 3g L-carnitine, 20g serine and 5g N-acetylcystein, first as single compounds, then combined, on 5 days |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Male |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: Healthy without any medication, no smokers, no obesity Exclusion Criteria: Any known disease, obesity |
Outcome
Primary Outcome Measures
1. Changes of plasma levels of nicotinamide riboside measured by mass spectrometry [Twenty-four hours after administration]
2. Changes of plasma levels of L-carnitine measured by mass spectrometry [Twenty-four hours after administration]
3. Changes of plasma levels of L-serine measured by mass spectrometry [Twenty-four hours after administration]
4. Changes of plasma levels of N-acetylcystein measured by mass spectrometry [Twenty-four hours after administration]
Secondary Outcome Measures
1. Changes in the plasma level of metabolites associated with the supplementation of metabolic co-factors. [Twenty-four hours after administration of combined cofactors]
2. Changes in the plasma level of inflammation-related proteins associated with the supplementation of metabolic co-factors. [Twenty-four hours after administration of combined cofactors]
