Effect of Different Ingestion Doses of Celastrol on Human Sperm Motility

NCT ID: NCT05413226

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2022-07-15

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

Conditions

Safety Issues

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Amount of Celastrol Administered

Increasing doses of Celastrol to each of five male subjects

Group Type: EXPERIMENTAL

Celastrol

Intervention Type: DIETARY_SUPPLEMENT

Four increasing doses of Celastrol to each of five men.

Interventions

Celastrol

Four increasing doses of Celastrol to each of five men.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

24,25,26-trinoroleana-1(10),3,5,7- tetraen-29-oic acid

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Legend Labz, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rubin Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Legend Labz, Inc.

Locations

Patient Urgent Care Clinic

Baton Rouge, Louisiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rubin Patel, MD

Role: CONTACT

rubin@patientplusuc.com

225-224-8690

Sarah C Cabellero

Role: CONTACT

scabal4@lsu.edu

225-224-8690

Facility Contacts

Rubin Patel, MD

Role: primary

rubin@patientplusuc.com

225-831-1241

Other Identifiers

AMT-001-2021

Identifier Type: -

Identifier Source: org_study_id