Trial Outcomes & Findings for Effects of Octacosanol During Taekwondo Training (NCT NCT03557476)

NCT ID: NCT03557476

Last Updated: 2020-11-10

Results Overview

Plasma triglyceride levels

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: 6 days
• Results posted on: 2020-11-10

Participant Flow

Participant milestones

Measure	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. Octacosanol: One capsules (20-mg) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed twice a day	Placebo A placebo pill was taken twice daily in replacement of the octacosanol supplement Placebo: A placebo pill was taken twice a day in a double-blinded method at the same frequency and time as the octacosanol supplement
Overall Study STARTED	13	13
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Octacosanol During Taekwondo Training

Baseline characteristics by cohort

Measure	Octacosanol n=13 Participants 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. Octacosanol: One capsules (20-mg) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed twice a day	Placebo n=13 Participants A placebo pill was taken twice daily in replacement of the octacosanol supplement Placebo: A placebo pill was taken twice a day in a double-blinded method at the same frequency and time as the octacosanol supplement	Total n=26 Participants Total of all reporting groups
Age, Continuous	18 years STANDARD_DEVIATION 1 • n=5 Participants	18 years STANDARD_DEVIATION 1 • n=7 Participants	18 years STANDARD_DEVIATION 1.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 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	13 Participants n=5 Participants	13 Participants n=7 Participants	26 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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
Region of Enrollment South Korea	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Height	174.7 cm STANDARD_DEVIATION 1.4 • n=5 Participants	173.9 cm STANDARD_DEVIATION 6.3 • n=7 Participants	174.3 cm STANDARD_DEVIATION 3.9 • n=5 Participants
Weight	66.9 kg STANDARD_DEVIATION 6.7 • n=5 Participants	66.7 kg STANDARD_DEVIATION 5.7 • n=7 Participants	66.8 kg STANDARD_DEVIATION 6.2 • n=5 Participants
Body fat	8 percentage of body fat STANDARD_DEVIATION 2 • n=5 Participants	8 percentage of body fat STANDARD_DEVIATION 2 • n=7 Participants	8 percentage of body fat STANDARD_DEVIATION 2.4 • n=5 Participants

PRIMARY outcome

Timeframe: 6 days

Plasma triglyceride levels

Outcome measures

Measure	Octacosanol n=13 Participants 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. Octacosanol: One capsules (20-mg) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed twice a day	Placebo n=13 Participants A placebo pill was taken twice daily in replacement of the octacosanol supplement Placebo: A placebo pill was taken twice a day in a double-blinded method at the same frequency and time as the octacosanol supplement
Triglycerides	34.9 mg/dL Standard Deviation 7.8	110 mg/dL Standard Deviation 8.1

PRIMARY outcome

Timeframe: 6 days

Plasma total cholesterol levels

Outcome measures

Measure	Octacosanol n=13 Participants 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. Octacosanol: One capsules (20-mg) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed twice a day	Placebo n=13 Participants A placebo pill was taken twice daily in replacement of the octacosanol supplement Placebo: A placebo pill was taken twice a day in a double-blinded method at the same frequency and time as the octacosanol supplement
Total Cholesterol	164 mg/dL Standard Deviation 12.8	173.5 mg/dL Standard Deviation 16.1

PRIMARY outcome

Timeframe: 6 days

Plasma levels of high-density lipoprotein

Outcome measures

Measure	Octacosanol n=13 Participants 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. Octacosanol: One capsules (20-mg) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed twice a day	Placebo n=13 Participants A placebo pill was taken twice daily in replacement of the octacosanol supplement Placebo: A placebo pill was taken twice a day in a double-blinded method at the same frequency and time as the octacosanol supplement
High-density Lipoprotein	71 mg/dL Standard Deviation 4.4	49.2 mg/dL Standard Deviation 2.6

PRIMARY outcome

Timeframe: 6 days

Plasma levels of low-density lipoprotein

Outcome measures

Measure	Octacosanol n=13 Participants 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. Octacosanol: One capsules (20-mg) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed twice a day	Placebo n=13 Participants A placebo pill was taken twice daily in replacement of the octacosanol supplement Placebo: A placebo pill was taken twice a day in a double-blinded method at the same frequency and time as the octacosanol supplement
Low-density Lipoprotein	92.6 mg/dL Standard Deviation 8.1	114.9 mg/dL Standard Deviation 10.8

SECONDARY outcome

Timeframe: 6 days

Plasma levels of malondialdehyde

Outcome measures

Measure	Octacosanol n=13 Participants 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. Octacosanol: One capsules (20-mg) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed twice a day	Placebo n=13 Participants A placebo pill was taken twice daily in replacement of the octacosanol supplement Placebo: A placebo pill was taken twice a day in a double-blinded method at the same frequency and time as the octacosanol supplement
Malondialdehyde	0.25 mmol/mL Standard Deviation 0.1	0.93 mmol/mL Standard Deviation 0.12

SECONDARY outcome

Timeframe: 6 days

Plasma levels of superoxide dismutase

Outcome measures

Measure	Octacosanol n=13 Participants 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. Octacosanol: One capsules (20-mg) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed twice a day	Placebo n=13 Participants A placebo pill was taken twice daily in replacement of the octacosanol supplement Placebo: A placebo pill was taken twice a day in a double-blinded method at the same frequency and time as the octacosanol supplement
Superoxide Dismutase	1450 U/gHb Standard Deviation 138.9	1010 U/gHb Standard Deviation 150.1

SECONDARY outcome

Timeframe: 6 days

Plasma levels of glutathione peroxidase

Outcome measures

Measure	Octacosanol n=13 Participants 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. Octacosanol: One capsules (20-mg) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed twice a day	Placebo n=13 Participants A placebo pill was taken twice daily in replacement of the octacosanol supplement Placebo: A placebo pill was taken twice a day in a double-blinded method at the same frequency and time as the octacosanol supplement
Glutathione Peroxidase	66.9 U/gHb Standard Deviation 10.8	47.1 U/gHb Standard Deviation 9.7

Adverse Events

Octacosanol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Song-Young Park

The University of Nebraska at Omaha

Phone: 402-554-3374

Email: song-youngpark@unomaha.edu

Results disclosure agreements

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