Effect of Different Ingestion Doses of Celastrol on Human Sperm Motility

Safety Issues Clinical Trial

Official title:

Effect of Different Ingestion Doses of Celastrol on Human Sperm Motility

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05413226
• Other study ID #: AMT-001-2021
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: June 2022
• Source: Legend Labz, Inc.
• Contact: Rubin Patel, MD
• Phone: 225-224-8690
• Email: rubin[@]patientplusuc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Safety Issues

Intervention

Dietary Supplement:
• Celastrol
Four increasing doses of Celastrol to each of five men.

Locations

Country	Name	City	State
United States	Patient Urgent Care Clinic	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Legend Labz, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motility of Sperm in 1 mL of Ejaculate after Celastrol Ingestion	Sperm samples will be analyzed independently for sperm motility	One Month
Primary	Amount of Sperm in 1 mL of Ejaculate after Celastrol Ingestion	Sperm samples will be analyzed independently for number of sperm	One Month