Carnitine and Liver Mitochondria Fatty Acid Processing

Obesity Clinical Trial

Official title:

Effects of Carnitine Supplementation on Liver Mitochondria Fatty Acid Processing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03193125
• Other study ID #: PBRC 2016-076
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: May 11, 2018

Study information

• Verified date: September 2022
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This double-blind, placebo-controlled randomized trial will assess whether 14 days of oral carnitine supplementation modifies mitochondrial fatty acid processing in healthy young adults.

Description:

This project will use stable isotope techniques and magnetic resonance spectroscopy (MRS) to take a first step toward clarifying how the benefit of oral carnitine supplementation depends on basal mitochondrial fatty acid processing (MFAP) and MFAP modification, with a specific focus on the liver. Approximately 24 healthy young individuals will be enrolled, with 20 expected to complete. Before and after 14 days of oral carnitine supplementation or placebo, MFAP will be measured using measures of acetyl-carnitine concentration (from long-TE proton MRS) and de novo lipogenesis (DNL, from analysis of blood metabolites following 13C-labeled acetate infusion and high-fructose drink challenge). The MFAP measures will be collected before and after loading participants with a high-fructose drink. Fructose is solely metabolized by the liver.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 11, 2018
• Est. primary completion date: May 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age 20-40 years
• BMI of 24.5-35.5 kg/m2
• Willingness to eat a prescribed diet of standard meals for a total of six days
• Willingness to undergo carnitine or placebo supplementation for two weeks
• Willingness to undergo study procedures including blood draws, MRS, C13 acetate infusion, DXA, muscle biopsy, and consumption of a sugary drink over the course of 6 hours

Exclusion Criteria:

• Unstable weight in the last 3 months (gain or loss >7 lb (3.2 kg)
• Significant changes in the diet or level of physical activity within the past month
• Clinical history of diabetes or cancer
• Clinically diagnosed heart, kidney, lung, thyroid, liver disease or abnormal liver enzymes that are, in the opinion of the investigator, clinically significant and represent a problem for study inclusion
• Screening fasting glucose > 125 mg/dL
• Screening blood pressure >140 systolic or >90 diastolic
• Use of certain prescribed medications at the discretion of the MI
• Smoking or use of tobacco products in the last 6 months
• Pregnancy or breastfeeding
• Clinically diagnosed neuropsychiatric conditions
• Diets that deviate extremely from the typical western diet in terms of increased meat intake are excluded, at the discretion of the MI.
• Known aversion to or refusal to drink sugary beverages
• Taking any over the counter drugs that alter the intestinal tract, at the discretion of the MI (for example, anti-cholinergic drugs and erythromycin)
• Have taken carnitine supplements regularly in the past 3 months
• Unwilling to discontinue use of dietary supplements containing significant amounts of carnitine or abstain from use one week prior to trial, at the discretion of the MI
• Women who have undergone partial hysterectomy with intact ovarian function
• Standard contra-indications to MRS, including non-removable metallic or electronic implants, claustrophobia or other fear of confinement, or inability to tolerate loud scanner noise
• Calf does not fit into the MRI coil, at the discretion of the PI
• Refusal to allow use of anonymized versions of collected data for research after this study is over

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Insulin Resistance
• Obesity

Intervention

Dietary Supplement:
• L-Carnitine
500 mg tablets of L-Carnitine taken 3 times daily before meals.
• Placebo
500 mg tablets of L-Carnitine taken 3 times daily before meals.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Touro University, University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver mitochondrial fatty acid processing	Change from baseline in liver mitochondrial fatty acid processing during high-fructose drink challenge	Day 18