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Amino Acid Supplement
Amino Acid Supplement for Insulin-Like Growth Factor I (IGF-I)
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
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
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
Find a Location
Who is running the clinical trial?
KGK Science Inc.Industry Sponsor
78 Previous Clinical Trials
6,040 Total Patients Enrolled
ZandA Technologies, llcLead Sponsor
David Crowley, MDPrincipal InvestigatorKGK Science Inc.
35 Previous Clinical Trials
2,633 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have cancer, except for a certain type of skin cancer that has been completely removed without needing chemotherapy or radiation. If you have been in remission from cancer for more than five years, you can still participate.I'm sorry, but you didn't provide a specific criterion after "Or." Could you please provide more information or another criterion for me to summarize?You are using two forms of birth control.You have an intrauterine device (IUD) inserted in your uterus.You are allergic or sensitive to any of the ingredients in the experimental medication.You have or have had a serious brain disease that affects memory and thinking, like Alzheimer's disease or vascular dementia.You have had a problem with alcohol or drugs in the past two years or are currently seeking treatment for alcohol or substance abuse.You have a history of stomach, liver, or kidney problems, or any other condition that could affect how medications are processed in your body, according to the doctor's opinion.
Research Study Groups:
This trial has the following groups:- Group 1: Amino Acid Supplement
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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