Oxidative StressNCT03557476
Effects of Octacosanol During Taekwondo Training
A study testing Octacosanol in people with Oxidative Stress and Dyslipidemias, run by Kosin University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 19 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Dyslipidemias
- What is being tested?
- Octacosanol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 19 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska at Omaha
Omaha, Nebraska, 68182
About this study
Official title: Octacosanol Supplementation Improves Lipid Profiles and Oxidative Stress During Rapid Weight Loss and High-Intensity Exercise in Taekwondo Athletes
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.
- Conditions
- Oxidative Stress, Dyslipidemias
- Being tested
- Octacosanol, Placebo
- Keywords
- Octacosanol, Taekwondo, Lipid Profiles, Oxidative Stress
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctacosanolDietary supplement
One capsules (20-mg) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed twice a day
PlaceboDietary supplement
A placebo pill was taken twice a day in a double-blinded method at the same frequency and time as the octacosanol supplement
| Study group | Role | What they receive |
|---|---|---|
| Octacosanol | Experimental | 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. Receives: Dietary Supplement: Octacosanol |
| Placebo | Placebo comparator | A placebo pill was taken twice daily in replacement of the octacosanol supplement Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglycerides
Plasma triglyceride levels
Measured: 6 days
Total Cholesterol
Plasma total cholesterol levels
Measured: 6 days
High-density Lipoprotein
Plasma levels of high-density lipoprotein
Measured: 6 days
Low-density Lipoprotein
Plasma levels of low-density lipoprotein
Measured: 6 days
Secondary outcomes (3)
Malondialdehyde
Plasma levels of malondialdehyde
Measured: 6 days
Superoxide Dismutase
Plasma levels of superoxide dismutase
Measured: 6 days
Glutathione Peroxidase
Plasma levels of glutathione peroxidase
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 Aug 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kosin University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nebraska
- Responsible party
- Principal investigator, Sang-Ho Lee, Kosin University
- Investigators
- Song Park, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557476
- Sponsor's protocol ID
- Octacosanol
- Status last verified
- Nov 2020
- First submitted
- 4 Jun 2018
- Last updated
- 10 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Octacosanol Supplementation Improves Lipid Profiles and Oxidative Stress During Rapid Weight Loss and High-Intensity Exercise in Taekwondo Athletes
- ClinicalTrials.gov ID
- NCT03557476
- Acronym / sponsor ID
- Octacosanol
- Conditions
- Oxidative Stress, Dyslipidemias
- Keywords
- Octacosanol, Taekwondo, Lipid Profiles, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Kosin UniversityUniversity, hospital or other
- Collaborators
- University of Nebraska
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Posted 12 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octacosanol | Experimental | Dietary Supplement: OctacosanolTwo 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboA placebo pill was taken twice daily in replacement of the octacosanol supplement |
Who may qualify
- Ages
- 17 to 19 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OctacosanolOne capsules (20-mg) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed twice a day | Dietary supplement | Octacosanol |
| PlaceboA placebo pill was taken twice a day in a double-blinded method at the same frequency and time as the octacosanol supplement | Dietary supplement | Placebo |
Primary outcome
Triglycerides
Time frame: 6 days
Plasma triglyceride levels
Total Cholesterol
Time frame: 6 days
Plasma total cholesterol levels
High-density Lipoprotein
Time frame: 6 days
Plasma levels of high-density lipoprotein
Low-density Lipoprotein
Time frame: 6 days
Plasma levels of low-density lipoprotein
3 secondary outcomes
Malondialdehyde
Time frame: 6 days
Superoxide Dismutase
Time frame: 6 days
Glutathione Peroxidase
Time frame: 6 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Song Park, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Octacosanol in people with Oxidative Stress and Dyslipidemias, run by Kosin University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triglycerides (time frame: 6 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.