Safety Issues
Conditions
Keywords
sperm motility, sperm count, celastrol
Brief summary
Five healthy participants with normal sperm counts and motility will ingest increasing doses of celastrol over a period of several days. After each dose ingestion the participants will provide an ejaculate the next day for sperm analysis. The objective is to see if increasing ingestion levels of celastrol will affect the sperm counts and motility of the participants.
Detailed description
Experimental Design This will be an escalating dose study to determine the effects of different enteral dosages on sperm motility. Five healthy participants, of any ethnicity, between 18 and 40 years of age will be candidates for the study. Baseline Days 1- 3 The five participants arrive at the clinic on Baseline Day 1, and will sign Consent Forms after being qualified by the inclusion and exclusion criteria. The participants will provide the first of three qualifying sperm samples (a sperm count of \ 20 million sperm per milliliter of ejaculate, and sperm motility of ≥ 40% one hour after ejaculate). If the participants initial sample is normal, then the participants will return to the clinic after three or more days to provide a second sperm sample. Again, if this second sample also meets the sperm count of \ 20 million sperm per milliliter of ejaculate, and sperm motility of ≥ 40% one hour after ejaculate, then the participants will return to the clinic for a third time and provide a third and final qualifying sperm sample. The average of the qualifying sperm counts obtained during the three-day qualifying period will be used for the Baseline data, and will be used to compare sperm counts of the participants who ingest Celastrol during the remaining Experimental Days. Experimental Day 1 All participants that provide three sperm samples that meet the qualifying criteria, will then return to the clinic after three or more days and have the participant medical histories taken; receive a physical examination; and have a blood sample taken. The five participants will be instructed to ingest the first dose of Celastrol (6.7 mg). Three hours after ingestion of this dose, the participants will provide a sperm sample. Experimental Day 2 The participants will return to the clinic three days (or more) after Experimental Day 1. The five participants will be instructed to ingest the second dose of Celastrol (20.1 mg). Three hours after ingestion of this dose, the participants will provide another sperm sample. Experimental Day 3 The participants will return to the clinic three days (or more) after Experimental Day 2. The five participants will be instructed to ingest the third dose of Celastrol (40.2 mg). Three hours after ingestion of this dose, the participants will provide another sperm sample. Experimental Day 4 The participants will return to the clinic three days (or more) after Experimental Day 3. The five participants will be instructed to ingest the fourth dose of Celastrol (67.0 mg). Three hours after ingestion of this dose, the participants will provide another sperm sample. The doses will be: 6.7 mg Commercial Dosage 20.1 mg 3x the Commercial Dose 40.2 mg 6x the Commercial Dose 67.0 mg 10x the Commercial Dose
Interventions
DIETARY_SUPPLEMENTCelastrol
Four increasing doses of Celastrol to each of five men.
Sponsors
Legend Labz, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
The participants will be masked to the dose
Intervention model description
Healthy males from 18 to 40 years old
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Individuals who are between 18 and 40 years of age and who are found to be healthy without any underlying medical conditions that could affect sperm motility, and are not taking any daily medications. This does not exclude patients who take drugs prn. 2. Individuals who have not be involved in other clinical trials during the last 90 days. -
Exclusion criteria
1. Individuals who have been involved in any other clinical trial during the last 90 days. 2. Individuals who have sperm counts lower than that considered normal. i.e. a sperm count of \ 20 million sperm per milliliter of ejaculate, and (b) sperm motility of ≥ 40% one hour after ejaculate. 3. Clinically significant cardiac disease including uncontrolled congestive heart failure and unstable angina 4. Individuals on medications that the clinician feels may affect sperm motility and/or otherwise interfere with the results 5. Medications that might interfere with blood chemistry, or CBCs 6. Subjects who are taking daily medications. The use of therapies prn is allowed. 7. Subjects Less than 18 years of age or over 40 years of age 8. Prisoners 9. Subjects who have taken anabolic steroid or testosterone during the last six months. 10. Subjects with a current history of addictive alcohol or illegal drug abuse (e.g. cocaine, heroin, etc.). The use of marijuana is allowed, but not preferred. 11. Subjects who are taking 5-alpha-reductase inhibitors (finasteride (Propecia®) and dutasteride (Avodart®), or Chemotherapy: - 12. Smokers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motility of Sperm in 1 mL of Ejaculate after Celastrol Ingestion | One Month | Sperm samples will be analyzed independently for sperm motility |
| Amount of Sperm in 1 mL of Ejaculate after Celastrol Ingestion | One Month | Sperm samples will be analyzed independently for number of sperm |
Countries
United States
Contacts
Primary ContactRubin Patel, MD
Backup ContactSarah C Cabellero
Outcome results
None listed