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CompletedNCT03557476Updated Nov 10, 2020Results posted

Effects of Octacosanol During Taekwondo Training

An interventional study of Octacosanol and Placebo in Oxidative Stress and Dyslipidemias, sponsored by Kosin University. Completed at 1 site in United States. Open to male participants aged 17 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-10.

Sponsored by Kosin University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Aug 2017, registered Jun 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
17 Years to 19 Years
Sex
Male
01

Study summary

Taekwondo players undergo rapid reductions of body weight prior to their competition in order to gain a size advantage over the opponent. However, these large weight changes with concomitant high intensity exercise training induce poor lipid profiles and high levels of oxidative stress, which can be detrimental to health and sports performance. Therefore, the purpose of this study was to investigate the ability of the nutritional supplement octacosanol to combat the physiological detriments that can occur from these rapid weight changes paired with high intensity exercise training.

Read the detailed description

Athletes that participate in weight division sports such as taekwondo, boxing, judo, and wrestling regularly reduce their body weight severely prior to competition in order to gain a size advantage over the opponent while simultaneously meeting their weight division requirements. In general, athletes have acute weight loss of 4-7 kg within 3-4 days of competition, while longer periods of more gradual weight loss of 15-22 kg lasting 3-4 weeks. Although this kind of extreme weight loss can induce metabolic dysfunction, it is repeatedly performed by athletes of weight division sports in order to acquire a more advantageous condition for play. Furthermore, athletes participating in matches tend to obtain excessive weights compared to their weight division during the offseason in order to lift heavier weights during training, and then rapidly lose that weight over a short period of time prior to competition, resulting in the deterioration of physiological function and possibly sports performance.

Rapid weight loss with high intensity exercise training also increases oxygen free radical production to a point that exceeds the defense mechanism of antioxidant enzymes in the body and ultimately results in damage to the cells, specifically, the lipid peroxidation of cell membranes. Not only does this decrease physiological function, but sports performance can also decrease as oxidative stress increases due to an interference in metabolic activity, a reduction in vascular function and an increase in systemic inflammation. Octacosanol, a straight-chain, high-molecular-weight, primary aliphatic alcohol minimally contained in the germinal disks of rice bran, wheat and sugar cane, may be able to prevent these deteriorations as it has been shown to provide various health benefits. In fact, previous studies reported that pre-exercise octacosanol intake contributed to enhanced muscular strength, muscular endurance and oxygen transport ability. Additionally, octacosanol supplementation has been shown to improve cardiovascular endurance and heart function in patients with peripheral artery disease, improve levels of low-density and high-density lipoprotein-cholesterol in patients with hypercholesterolemia, and increase glycogen accumulation in mice9. However, the potential beneficial effects of octacosanol intake for reducing free radical production and preventing detrimental physiological function from excessive weight loss with high intensity exercise has not been examined. Thus, the purpose of this study was to investigate the effects of octacosanol supplementation during acute weight loss with high-intensity exercise training on lipid profiles and markers of oxidative stress in taekwondo players.

02

Conditions studied

  • Oxidative Stress
  • Dyslipidemias

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Keywords

  • Octacosanol
  • Taekwondo
  • Lipid Profiles
  • Oxidative Stress
03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's enrollment of 26 is below the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Kosin University is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 19 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • at least 3 years of experience in national taekwondo competitions
  • abstain from caffeinated drinks, alcohol, and antioxidant supplements during the whole period of the study

Exclusion criteria

Exclusion Criteria:

  • no history of chronic use of antioxidants, chronic aspirin, and nonsteroidal anti-inflammatory drugs (NSAIDs)
  • No cardiovascular, neurological, metabolic or renal diseases
  • no musculoskeletal injuries
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Octacosanol

    Two capsules (20-mg x 2) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed daily by the octacosanol group for six days, one capsule 30 minutes after morning and afternoon meals.

    Dietary Supplement: Octacosanol

  • Placebo comparator
    Placebo

    A placebo pill was taken twice daily in replacement of the octacosanol supplement

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementOctacosanol

    One capsules (20-mg) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed twice a day

  • Dietary supplementPlacebo

    A placebo pill was taken twice a day in a double-blinded method at the same frequency and time as the octacosanol supplement

06

What researchers measure

Primary outcomes

  1. Triglycerides

    Plasma triglyceride levels

    Time frame: 6 days

  2. Total Cholesterol

    Plasma total cholesterol levels

    Time frame: 6 days

  3. High-density Lipoprotein

    Plasma levels of high-density lipoprotein

    Time frame: 6 days

  4. Low-density Lipoprotein

    Plasma levels of low-density lipoprotein

    Time frame: 6 days

Secondary outcomes

  1. Malondialdehyde

    Plasma levels of malondialdehyde

    Time frame: 6 days

  2. Superoxide Dismutase

    Plasma levels of superoxide dismutase

    Time frame: 6 days

  3. Glutathione Peroxidase

    Plasma levels of glutathione peroxidase

    Time frame: 6 days

07

Results

Posted Aug 12, 2019

Participant flow

Participant flow — Overall Study
MilestoneOctacosanolPlacebo
Started1313
Completed1313
Not completed00

Outcome measures

PrimaryTriglycerides

Plasma triglyceride levels

Time frame:
6 days
Reported as:
Mean · mg/dL
Triglycerides
mg/dLOctacosanolPlacebo
Triglycerides34.9 ± 7.8110 ± 8.1
PrimaryTotal Cholesterol

Plasma total cholesterol levels

Time frame:
6 days
Reported as:
Mean · mg/dL
Total Cholesterol
mg/dLOctacosanolPlacebo
Total Cholesterol164 ± 12.8173.5 ± 16.1
PrimaryHigh-density Lipoprotein

Plasma levels of high-density lipoprotein

Time frame:
6 days
Reported as:
Mean · mg/dL
High-density Lipoprotein
mg/dLOctacosanolPlacebo
High-density Lipoprotein71 ± 4.449.2 ± 2.6
PrimaryLow-density Lipoprotein

Plasma levels of low-density lipoprotein

Time frame:
6 days
Reported as:
Mean · mg/dL
Low-density Lipoprotein
mg/dLOctacosanolPlacebo
Low-density Lipoprotein92.6 ± 8.1114.9 ± 10.8
SecondaryMalondialdehyde

Plasma levels of malondialdehyde

Time frame:
6 days
Reported as:
Mean · mmol/mL
Malondialdehyde
mmol/mLOctacosanolPlacebo
Malondialdehyde0.25 ± 0.10.93 ± 0.12
SecondarySuperoxide Dismutase

Plasma levels of superoxide dismutase

Time frame:
6 days
Reported as:
Mean · U/gHb
Superoxide Dismutase
U/gHbOctacosanolPlacebo
Superoxide Dismutase1450 ± 138.91010 ± 150.1
SecondaryGlutathione Peroxidase

Plasma levels of glutathione peroxidase

Time frame:
6 days
Reported as:
Mean · U/gHb
Glutathione Peroxidase
U/gHbOctacosanolPlacebo
Glutathione Peroxidase66.9 ± 10.847.1 ± 9.7

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Octacosanol0/13 (0%)0/13 (0%)0/13 (0%)
Placebo0/13 (0%)0/13 (0%)0/13 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)OctacosanolPlaceboTotal
Mean18 ± 118 ± 118 ± 1.3
Sex: Female, Male
Sex: Female, Male(Participants)OctacosanolPlaceboTotal
Female000
Male131326
Race (NIH/OMB)
Race (NIH/OMB)(Participants)OctacosanolPlaceboTotal
American Indian or Alaska Native000
Asian131326
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)OctacosanolPlaceboTotal
South Korea131326
Height
Height(cm)OctacosanolPlaceboTotal
Mean174.7 ± 1.4173.9 ± 6.3174.3 ± 3.9
Weight
Weight(kg)OctacosanolPlaceboTotal
Mean66.9 ± 6.766.7 ± 5.766.8 ± 6.2
Body fat
Body fat(percentage of body fat)OctacosanolPlaceboTotal
Mean8 ± 28 ± 28 ± 2.4
08

Study locations

1 site
  • University of Nebraska at Omaha
    Omaha, Nebraska 68182, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 25, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03557476
Lead sponsor
Kosin University
Collaborators
University of Nebraska
Responsible party
Sang-Ho Lee (Principal Investigator, Kosin University) — Principal investigator
First posted
Jun 15, 2018
Start date
Aug 1, 2017
Primary completion
Mar 1, 2018
Completion
Mar 1, 2018
Results posted
Aug 12, 2019
Last update
Nov 10, 2020

Study contacts

Song Park, PhD
principal investigator · University of Nebraska

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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