Trial Outcomes & Findings for Carnitine Supplementation and Skeletal Muscle Function (NCT NCT02692235)

NCT ID: NCT02692235

Last Updated: 2019-05-23

Results Overview

Serum C-reactive protein concentration determined by the enzyme immunoassay method using commercially available kit (Cloud-Clone Corp., Houston, USA)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 28 participants
• Primary outcome timeframe: baseline and after 24 weeks of supplementation period
• Results posted on: 2019-05-23

Participant Flow

42 subjects volunteered to participate in the study. After the initial screening, 28 were included in the study (14 subject not meeting inclusion criteria) and were randomly assigned to either an L-carnitine (n=14) or a placebo supplementation group (n=14).

Participant milestones

Measure	Carnitine 24 weeks l-carnitine-l-tartrate supplementation carnitine: 1500 mg/d l-carnitine-l-tartrate	Placebo 24 weeks isonitrogenous supplementation placebo: isonitrogenous
Overall Study STARTED	14	14
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	Carnitine 24 weeks l-carnitine-l-tartrate supplementation carnitine: 1500 mg/d l-carnitine-l-tartrate	Placebo 24 weeks isonitrogenous supplementation placebo: isonitrogenous
Overall Study Withdrawal by Subject	2	1
Overall Study Adverse Event	1	2

Baseline Characteristics

Carnitine Supplementation and Skeletal Muscle Function

Baseline characteristics by cohort

Measure	Carnitine n=14 Participants 24 weeks l-carnitine-l-tartrate supplementation carnitine: 1500 mg/d l-carnitine-l-tartrate	Placebo n=14 Participants 24 weeks isonitrogenous supplementation placebo: isonitrogenous	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Mass Index (BMI)	28.2 kg/m² STANDARD_DEVIATION 4.5 • n=5 Participants	28.0 kg/m² STANDARD_DEVIATION 5.9 • n=7 Participants	28.1 kg/m² STANDARD_DEVIATION 5.2 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and after 24 weeks of supplementation period

Population: 1 male and 1 smoking female subjects excluded from the \*Placebo\* statistical analyses for group homogeneity

Serum C-reactive protein concentration determined by the enzyme immunoassay method using commercially available kit (Cloud-Clone Corp., Houston, USA)

Outcome measures

Measure	Carnitine n=11 Participants 24 weeks l-carnitine-l-tartrate supplementation carnitine: 1500 mg/d l-carnitine-l-tartrate	Placebo n=9 Participants 24 weeks isonitrogenous supplementation placebo: isonitrogenous
Blood Inflammatory Marker baseline	2.6 mg·L^-1 Standard Deviation 0.3	1.8 mg·L^-1 Standard Deviation 0.3
Blood Inflammatory Marker after 24 weeks	2.9 mg·L^-1 Standard Deviation 0.4	1.7 mg·L^-1 Standard Deviation 0.3

SECONDARY outcome

Timeframe: baseline and after 24 weeks of supplementation period

Population: 1 male and 1 smoking female subjects excluded from the \*Placebo\* statistical analyses for group homogeneity

Change in serum lipid metabolites: total cholesterol (TCh), HDL-cholesterol (HDL), LDL-cholesterol (LDL), triglycerides (TG) determined by standard automatic analyzer Cobas 6000 (Roche Diagnostics, Mannheim, Germany)

Outcome measures

Measure	Carnitine n=11 Participants 24 weeks l-carnitine-l-tartrate supplementation carnitine: 1500 mg/d l-carnitine-l-tartrate	Placebo n=9 Participants 24 weeks isonitrogenous supplementation placebo: isonitrogenous
Lipid Metabolites TCh baseline	233 mg·dL^-1 Standard Deviation 13	221 mg·dL^-1 Standard Deviation 13
Lipid Metabolites TCh after 24 weeks	221 mg·dL^-1 Standard Deviation 14	196 mg·dL^-1 Standard Deviation 14
Lipid Metabolites HDL baseline	69 mg·dL^-1 Standard Deviation 5	68 mg·dL^-1 Standard Deviation 6
Lipid Metabolites HDL after 24 weeks	69 mg·dL^-1 Standard Deviation 5	61 mg·dL^-1 Standard Deviation 3
Lipid Metabolites LDL baseline	140 mg·dL^-1 Standard Deviation 11	130 mg·dL^-1 Standard Deviation 11
Lipid Metabolites LDL after 24 weeks	131 mg·dL^-1 Standard Deviation 11	115 mg·dL^-1 Standard Deviation 13
Lipid Metabolites TG baseline	116 mg·dL^-1 Standard Deviation 10	117 mg·dL^-1 Standard Deviation 22
Lipid Metabolites TG after 24 weeks	105 mg·dL^-1 Standard Deviation 16	98 mg·dL^-1 Standard Deviation 16

Adverse Events

Carnitine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Carnitine n=14 participants at risk 24 weeks l-carnitine-l-tartrate supplementation carnitine: 1500 mg/d l-carnitine-l-tartrate	Placebo n=14 participants at risk 24 weeks isonitrogenous supplementation placebo: isonitrogenous
Gastrointestinal disorders acid reflux	7.1% 1/14 • Number of events 1 • 6 months	7.1% 1/14 • Number of events 1 • 6 months
General disorders headache and dizziness	0.00% 0/14 • 6 months	7.1% 1/14 • Number of events 1 • 6 months

Additional Information

Robert Olek

AWFiS

Phone: +48 58 5547392

Email: robol@awf.gda.pl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place