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Carnitine and Liver Mitochondria Fatty Acid Processing

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ClinicalTrials.gov Identifier: NCT03193125
Recruitment Status : Unknown
Verified June 2017 by Owen Carmichael, Pennington Biomedical Research Center.
Recruitment status was:  Recruiting
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Collaborators:
University of Tennessee
Touro University
Information provided by (Responsible Party):
Owen Carmichael, Pennington Biomedical Research Center

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 5, 2017
Estimated Primary Completion Date : June 4, 2018
Estimated Study Completion Date : June 4, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Liver mitochondrial fatty acid processing [ Time Frame: Day 18 ]
    Change from baseline in liver mitochondrial fatty acid processing during high-fructose drink challenge



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193125


Contacts
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Contact: Robert Leonhard (225) 763-0948 Robert.Leonhard@pbrc.edu

Locations
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United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Robert Leonhard    225-763-0948    Robert.Leonhard@pbrc.edu   
Sponsors and Collaborators
Pennington Biomedical Research Center
University of Tennessee
Touro University
Investigators
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Principal Investigator: Owen Carmichael, Ph.D. Pennington Biomedical Research Center

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Responsible Party: Owen Carmichael, Associate Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT03193125     History of Changes
Other Study ID Numbers: 2016-076-PBRC
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized blood assay results, MRI data, and other de-identified clinical lab data will be shared with other researchers beginning 6 months after study completion. It may be obtained through a written request to the PI.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Insulin Resistance
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism