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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Four capsules of Amino Acid Supplement will be taken once a day for 90 days.
Four capsules of Placebo will be taken once a day for 90 days.
KGK Science Inc.
London, Ontario, Canada
The difference in serum IGF-1 concentrations from baseline up to 30 days of supplementation between Amino Acid Supplement (AAS) compared to placebo.
The difference in serum IGF-1 concentrations (ng/ml) from baseline (day 1) to 30 days (day 31) of supplementation between AAS will be compared to placebo
Time frame: baseline (day 1) and 31 days
The difference in serum IGF-1 concentrations from baseline up to 60 days of supplementation between Amino Acid Supplement (AAS) compared to placebo.
The difference in serum IGF-1 concentrations (ng/ml) from baseline (day 1) up to 60 days (day 61) of supplementation between AAS will be compared to placebo
Time frame: baseline (day 1) and 61 days
The difference in serum IGF-1 concentrations from baseline up to 90 days of supplementation between Amino Acid Supplement (AAS) compared to placebo.
The difference in serum IGF-1 concentrations (ng/ml) from baseline (day 1) up to 90 days (day 91) of supplementation between AAS will be compared to placebo
Time frame: baseline (day 1) and 91 days
Incidence of pre-emergent adverse events following 90 days of supplementation with Amino Acid Supplement (AAS) compared to placebo
Incidence of pre-emergent adverse events following 90 days of supplementation with Amino Acid Supplement (AAS) will be compared to placebo. A follow-up safety call will also be conducted 2 weeks after the 90 day treatment (day 105) with Amino Acid Supplement.
Time frame: 105 days
Incidence of post-emergent adverse events following 90 days of supplementation with Amino Acid Supplement (AAS) compared to placebo
Incidence of post-emergent adverse events following 90 days of supplementation with Amino Acid Supplement (AAS) will be compared to placebo. A follow-up safety call will also be conducted 2 weeks after the 90 day treatment (day 105) with Amino Acid Supplement.
Time frame: 105 days
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