Back to results

Carnitine and Liver Mitochondria Fatty Acid Processing

Primary Purpose

Diabetes Mellitus, Type 2, Insulin Resistance, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

L-Carnitine

Placebo

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Carnitine

Placebo

Arm Description

500 mg of L-carnitine to be taken 3 times a day 15 minutes before meals for 14 days.

500 mg of placebo to be taken 3 times a day 15 minutes before meals for 14 days.

Outcomes

Primary Outcome Measures

Liver mitochondrial fatty acid processing

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03193125

First Posted

June 16, 2017

Last Updated

September 26, 2022

Sponsor

Pennington Biomedical Research Center

Collaborators

University of Tennessee, Touro University

1. Study Identification

Unique Protocol Identification Number

NCT03193125

Brief Title

Carnitine and Liver Mitochondria Fatty Acid Processing

Official Title

Effects of Carnitine Supplementation on Liver Mitochondria Fatty Acid Processing

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

May 15, 2017 (Actual)

Primary Completion Date

May 11, 2018 (Actual)

Study Completion Date

May 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pennington Biomedical Research Center

Collaborators

University of Tennessee, Touro University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2, Insulin Resistance, Obesity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Carnitine

Arm Type

Experimental

Arm Description

500 mg of L-carnitine to be taken 3 times a day 15 minutes before meals for 14 days.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

500 mg of placebo to be taken 3 times a day 15 minutes before meals for 14 days.

Intervention Type

Dietary Supplement

Intervention Name(s)

L-Carnitine

Intervention Description

500 mg tablets of L-Carnitine taken 3 times daily before meals.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

500 mg tablets of L-Carnitine taken 3 times daily before meals.

Primary Outcome Measure Information:

Title

Liver mitochondrial fatty acid processing

Description

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

Time Frame

Day 18

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Owen Carmichael, Ph.D.

Organizational Affiliation

Pennington Biomedical Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pennington Biomedical Research Center

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Carnitine and Liver Mitochondria Fatty Acid Processing

We'll reach out to this number within 24 hrs