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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03193125
Other study ID # PBRC 2016-076
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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