Obesity Clinical Trial
Official title:
Effects of Carnitine Supplementation on Liver Mitochondria Fatty Acid Processing
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 |
Verified date | September 2022 |
Source | Pennington Biomedical Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Pennington Biomedical Research Center | Baton Rouge | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Pennington Biomedical Research Center | Touro University, University of Tennessee |
United States,
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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