Safety IssuesNCT05413226
Effect of Different Ingestion Doses of Celastrol on Human Sperm Motility
A study testing Celastrol in people with Safety Issues, run by Legend Labz, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- Celastrol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2021to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Individuals who have not be involved in other clinical trials during the last 90 days. -
Who cannot join
- Individuals who have been involved in any other clinical trial during the last 90 days.
- 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.
- Clinically significant cardiac disease including uncontrolled congestive heart failure and unstable angina
- Individuals on medications that the clinician feels may affect sperm motility and/or otherwise interfere with the results
- Medications that might interfere with blood chemistry, or CBCs
- Subjects who are taking daily medications. The use of therapies prn is allowed.
Show all 13Show fewer
- Subjects Less than 18 years of age or over 40 years of age
- Prisoners
- Subjects who have taken anabolic steroid or testosterone during the last six months.
- 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.
- Subjects who are taking 5-alpha-reductase inhibitors (finasteride (Propecia®) and dutasteride (Avodart®), or Chemotherapy: -
- Smokers
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Patient Urgent Care Clinic
Baton Rouge, Louisiana, 70808
Rubin Patel, MD, 225-831-1241, rubin@patientplusuc.com
About this study
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.
Read the 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
- Being tested
- Celastrol
- Keywords
- sperm motility, sperm count, celastrol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelastrolDietary supplement
Also called 24,25,26-trinoroleana-1(10),3,5,7- tetraen-29-oic acid
Four increasing doses of Celastrol to each of five men.
| Study group | Role | What they receive |
|---|---|---|
| Amount of Celastrol Administered | Experimental | Increasing doses of Celastrol to each of five male subjects Receives: Dietary Supplement: Celastrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motility of Sperm in 1 mL of Ejaculate after Celastrol Ingestion
Sperm samples will be analyzed independently for sperm motility
Measured: One Month
Amount of Sperm in 1 mL of Ejaculate after Celastrol Ingestion
Sperm samples will be analyzed independently for number of sperm
Measured: One Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start28 Sep 2021
- Primary completion15 Jul 2022 (estimated)
- Study completion15 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Healthy males from 18 to 40 years old
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Legend Labz, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rubin Patel, MD, Principal investigator, Legend Labz, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413226
- Sponsor's protocol ID
- AMT-001-2021
- Status last verified
- Jun 2022
- First submitted
- 24 Jul 2021
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Ingestion Doses of Celastrol on Human Sperm Motility
- ClinicalTrials.gov ID
- NCT05413226
- Acronym / sponsor ID
- AMT-001-2021
- Conditions
- Safety Issues
- Keywords
- sperm motility, sperm count, celastrol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Legend Labz, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Healthy males from 18 to 40 years old
| Arm | Type | Receives |
|---|---|---|
| Amount of Celastrol Administered | Experimental | Dietary Supplement: CelastrolIncreasing doses of Celastrol to each of five male subjects |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
- Individuals who have not be involved in other clinical trials during the last 90 days. -
Key exclusion criteria (13 listed)
- Individuals who have been involved in any other clinical trial during the last 90 days.
- 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.
- Clinically significant cardiac disease including uncontrolled congestive heart failure and unstable angina
- Individuals on medications that the clinician feels may affect sperm motility and/or otherwise interfere with the results
- Medications that might interfere with blood chemistry, or CBCs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelastrolAlso: 24,25,26-trinoroleana-1(10),3,5,7- tetraen-29-oic acidFour increasing doses of Celastrol to each of five men. | Dietary supplement | Amount of Celastrol Administered |
Primary outcome
Motility of Sperm in 1 mL of Ejaculate after Celastrol Ingestion
Time frame: One Month
Sperm samples will be analyzed independently for sperm motility
Amount of Sperm in 1 mL of Ejaculate after Celastrol Ingestion
Time frame: One Month
Sperm samples will be analyzed independently for number of sperm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubin Patel, MD principal investigator
Legend Labz, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celastrol in people with Safety Issues, run by Legend Labz, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rubin Patel, MD (225-224-8690, rubin@patientplusuc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motility of Sperm in 1 mL of Ejaculate after Celastrol Ingestion (time frame: One Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.