Carnitine and Liver Mitochondria Fatty Acid Processing

NCT03193125 | Completed

• 1 other identifier: PBRC 2016-076
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Obesity

Outcome Measures

Primary Outcomes (1)

• Liver mitochondrial fatty acid processing

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

  Day 18

Study Arms (2)

Carnitine

EXPERIMENTAL

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

Dietary Supplement: L-Carnitine

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

L-Carnitine DIETARY_SUPPLEMENT

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

Carnitine

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• University of Tennessee: collaborator
• Touro University: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Obesity

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Owen Carmichael, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 20, 2017
• Study Start: May 15, 2017
• Primary Completion: May 11, 2018
• Study Completion: May 11, 2018
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)