Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04420377 |
| Other study ID # |
0220 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2, 2020 |
| Est. completion date |
June 12, 2020 |
Study information
| Verified date |
February 2021 |
| Source |
Applied Science & Performance Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study investigated the effects of CarnipureTM, a high-quality L-carnitine ingredient, on
long term (5 weeks) recovery, muscle damage, and SOD status in a population of males and
females while training two days per week. The primary outcomes defining recovery were changes
in serum creatine kinase levels and perceptual changes in recovery. Supporting variables
included an assessment of strength and power as a functional indicator of recovery. This
study would be the first to examine the effects of CarnipureTM on long-term recovery. Our
primary hypothesis was that L-carnitine supplementation would reduce muscle damage and
improve perceptual measures of recovery. Our secondary hypotheses were that L-carnitine
supplementation would better sustain strength and power and elevate SOD status.
Description:
This study investigated the effects of CarnipureTM, a high-quality L-carnitine ingredient, on
long term (5 weeks) recovery, muscle damage, and SOD status in a population of males and
females while training two days per week. The primary outcomes defining recovery were changes
in serum creatine kinase levels and perceptual changes in recovery. Supporting variables
included an assessment of strength and power as a functional indicator of recovery. This
study would be the first to examine the effects of CarnipureTM on long-term recovery. Our
primary hypothesis was that L-carnitine supplementation would reduce muscle damage and
improve perceptual measures of recovery. Our secondary hypotheses were that L-carnitine
supplementation would better sustain strength and power and elevate SOD status.
In totality, the study will last 5-weeks, consisting of supplementation with maintenance
exercise performed 2 days per week, at home. Week 5 will consist of a pre-training
assessment, an intense lower-body strength endurance training day, and subsequent testing
48-hour testing (Post-Week 5). The baseline testing (will be performed on approximately 10
subjects per day over the course of 4 days) and will consist of the following measures:
- DEXA (Dual Energy X-ray Absorptiometry) Body Composition Analysis
- Blood Draw
- Salivary Measures
- Isometric Mid Thigh Pull
- Force Plate Mechanography
- Visual Analog Scales
For the first 4 weeks of training, participants will be asked to workout 2 days per week at
home.
On Monday of week five, 20 subjects will be assessed on the following measures:
- DXA
- Blood Draw
- Salivary Measures
- Isometric Mid Thigh Pull
- Force Plate Mechanography
- Visual Analog Scales
On Tuesday of week 5, the 20 subjects that tested on Monday, will go through an intense lower
body, strength endurance protocol, and the leftover 20 subjects will go through the following
assessments:
- DXA
- Blood Draw
- Salivary Measures
- Isometric Mid Thigh Pull
- Force Plate Mechanography
- Visual Analog Scales
- Before and After the workout - Finger Prick Blood Sample
On Wednesday of week 5, the 20 subjects that tested Monday, will have a day to rest. The 20
subjects that tested Tuesday, will go through an intense lower body strength endurance
protocol.
- Before and After the workout - Finger Prick Blood Sample (for blood lactate)
On Thursday of week 5, the 20 subjects that tested Tuesday will have the day off, while the
20 subjects that tested Monday will be assessed on the following measures:
- Blood Draw
- Salivary Measures
- Isometric Mid Thigh Pull
- Force Plate Mechanography
- Visual Analog Scales
On Friday of week 5, the 20 subjects that tested Tuesday will be assessed on the following
measures:
- Blood Draw
- Salivary Measures
- Isometric Mid Thigh Pull
- Force Plate Mechanography
- Visual Analog Scales
Participation will be sought from 80 male and female subjects ranging from 21 to 65 years old
who are active (i.e. 30 minutes per week of moderate activity classified as greater than 50 %
of their heart rate (HR) max 3 days • week-1). Two cohorts of 40 subjects will be examined in
the study.
The supplement will be administered as a dose of 2g of Carnipure (L-carnitine), per day for
the duration of the study. Placebo and treatment conditions will be administered in visually
identical capsules. Statistical analysis will be carried out on the entire study population
and on the female study population independently.
