The Efficacy and Safety of an Amino Acid Supplement in Adults

Phase 2

Waitlist Available

Led By David Crowley, MD

Research Sponsored by ZandA Technologies, llc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 1) and 91 days

Summary

This trial is testing a steroid pill to see if it can increase levels of a growth factor in the blood. The study focuses on adults aged 35-75 because they often have lower levels of this growth factor. Researchers will also check if the pill is safe and well-tolerated.

Eligible Conditions

Insulin-Like Growth Factor I (IGF-I)
Healthy Subjects

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1) and 91 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1) and 91 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and 91 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Somatomedins

The difference in serum IGF-1 concentrations from baseline up to 60 days of supplementation between Amino Acid Supplement (AAS) compared to placebo.

Somatomedins

Secondary study objectives

Amino Acids

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Amino Acid SupplementExperimental Treatment1 Intervention

Participants will be instructed to take four (4) capsules of Amino Acid Supplement with a full glass of water daily for up to 90 days, starting on day 1. No substance other than water (i.e., food, drink other than water, and/or medication, supplement, vitamin, and/or mineral) can be consumed two hours before or after taking the Investigational Product (IP). The IP must be consistently consumed immediately before nighttime sleep throughout the study. If a dose is missed participants are instructed to record the missed dose in their study journal. Missed doses will not be taken at a later time or date. If any substance other than water is consumed two hours before or after taking the IP, that IP use will be counted as a missed dose. Participants will be advised not to exceed four (4) capsules daily.

Group II: PlaceboPlacebo Group1 Intervention

Participants will be instructed to take four (4) capsules of Placebo with a full glass of water daily for up to 90 days, starting on day 1. No substance other than water (i.e., food, drink other than water, and/or medication, supplement, vitamin, and/or mineral) can be consumed two hours before or after taking the placebo. The placebo must be consistently consumed immediately before nighttime sleep throughout the study. If a dose is missed participants are instructed to record the missed dose in their study journal. Missed doses will not be taken at a later time or date. If any substance other than water is consumed two hours before or after taking the placebo, that placebo use will be counted as a missed dose. Participants will be advised not to exceed four (4) capsules daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Amino Acid Supplement

2022

Completed Phase 2

~120

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