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The Efficacy and Safety of an Amino Acid Supplement in Adults

NCT05599282 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-04-04

No results posted yet for this study

Summary

The primary objective of this clinical trial is to determine the efficacy of once daily oral AAS use, as compared to placebo, in increasing serum IGF-1 concentrations within adults aged 35-75 years for up to 90 days. Additionally, the safety and tolerability of the AAS, as compared to placebo, will be measured by the occurrence of and/or changes in treatment-emergent adverse events (AEs).

For the study population, the eligibility criteria limit the presence of confounding variables that could influence study outcomes. Participants will be men and women between 35 and 75 years of age to account for the age range in which humans experience a decline in HGH/IGF-1. Each participant will be deemed eligible to participate by the Qualified Investigator (QI) by means of an extensive review of medical history, laboratory results, and physical examination. Participants will be required to have body mass index (BMI) measurements between 18.5 and 35.0 kg/m2 to ensure that their body weight/composition will not have a confounding effect on their HGH levels (18, 19) and to facilitate generalizability. Participants will be required to maintain current medication and supplements use and sleep throughout the study. They must also abstain from any over-the counter (OTC) medications and/or supplements that may affect the efficacy or safety of the AAS.

Conditions

  • Insulin-Like Growth Factor I
  • Healthy

Interventions

DRUG

Amino Acid Supplement

Four capsules of Amino Acid Supplement will be taken once a day for 90 days.

OTHER

Placebo

Four capsules of Placebo will be taken once a day for 90 days.

Sponsors & Collaborators

  • KGK Science Inc.

    collaborator INDUSTRY

  • ZandA Technologies, llc

    lead OTHER

Principal Investigators

  • David Crowley, MD · KGK Science Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-26
Primary Completion
2024-01-08
Completion
2024-01-22

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05599282 on ClinicalTrials.gov