Carnitine and Liver Mitochondria Fatty Acid Processing

• Sponsor: Pennington Biomedical Research Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03193125
• Collaborator: University of Tennessee (Other), Touro University (Other)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2; Insulin Resistance; Obesity	Dietary Supplement: L-Carnitine; Dietary Supplement: Placebo	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effects of Carnitine Supplementation on Liver Mitochondria Fatty Acid Processing
• Actual Study Start Date: Jun 5, 2017
• Anticipated Primary Completion Date: Jun 4, 2018
• Anticipated Study Completion Date: Jun 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Carnitine 500 mg of L-carnitine to be taken 3 times a day 15 minutes before meals for 14 days.	Dietary Supplement: L-Carnitine; 500 mg tablets of L-Carnitine taken 3 times daily before meals.
Placebo Comparator: Placebo 500 mg of placebo to be taken 3 times a day 15 minutes before meals for 14 days.	Dietary Supplement: Placebo; 500 mg tablets of L-Carnitine taken 3 times daily before meals.

Outcome Measures

Primary Outcome Measures

1. Liver mitochondrial fatty acid processing [Day 18]

   Change from baseline in liver mitochondrial fatty acid processing during high-fructose drink challenge

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

• Pennington Biomedical Research Center
• University of Tennessee
• Touro University

Investigators

• Principal Investigator: Owen Carmichael, Ph.D., Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Owen Carmichael, Associate Professor, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT03193125
• Other Study ID Numbers: 2016-076-PBRC
• First Posted: Jun 20, 2017
• Last Update Posted: Jun 20, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance

Study Results

No Results Posted as of Jun 20, 2017