Effect of Different Ingestion Doses of Celastrol on Human Sperm Motility

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.

Study Overview

• Status: Recruiting
• Conditions: Safety Issues
• Intervention / Treatment: Dietary supplement: Celastrol

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

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rubin Patel, MD; Phone Number: 225-224-8690; Email: rubin@patientplusuc.com
• Study Contact Backup: Name: Sarah C Cabellero; Phone Number: 225-224-8690; Email: scabal4@lsu.edu

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Recruiting
      • Patient Urgent Care Clinic
      • Contact: Rubin Patel, MD; Phone Number: 225-831-1241; Email: rubin@patientplusuc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amount of Celastrol Administered; Increasing doses of Celastrol to each of five male subjects	Dietary supplement: Celastrol; Four increasing doses of Celastrol to each of five men.; Other Names: 24,25,26-trinoroleana-1(10),3,5,7- tetraen-29-oic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motility of Sperm in 1 mL of Ejaculate after Celastrol Ingestion	Sperm samples will be analyzed independently for sperm motility	One Month
Amount of Sperm in 1 mL of Ejaculate after Celastrol Ingestion	Sperm samples will be analyzed independently for number of sperm	One Month

Collaborators and Investigators

• Sponsor: Legend Labz, Inc.
• Investigators: Principal Investigator: Rubin Patel, MD, Legend Labz, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Anticipated): July 15, 2022
• Study Completion (Anticipated): July 15, 2022

Study Registration Dates

• First Submitted: July 24, 2021
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: sperm motility; sperm count; celastrol
• Other Study ID Numbers: AMT-001-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No