A 90-day, Double-blind, Placebo-controlled, Randomized, Parallel-Group Efficacy and Safety Study of an Amino Acid Supplement in Adults
Overview
- Phase
- Phase 2
- Intervention
- Amino Acid Supplement
- Conditions
- Insulin-Like Growth Factor I
- Sponsor
- ZandA Technologies, llc
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- The difference in serum IGF-1 concentrations from baseline up to 60 days of supplementation between Amino Acid Supplement (AAS) compared to placebo.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females between 35-75 years of age at baseline
- •Weigh at least 52 kg for males and 45 kg for females
- •BMI between 18.5-35.0 kg/m2, inclusive at screening
- •Serum IGF-1 concentrations within ≤ 2 SDs of age-adjusted reference range as defined by the clinical laboratory
- •Individual is not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
- •Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- •Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- •Double-barrier method
- •Intrauterine devices
- •Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
Exclusion Criteria
- •Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- •Allergy, sensitivity, or intolerance to investigational product (IP) and/or placebo active or inactive ingredients
- •Has a condition known to directly involve and/or affect IGF-1, including acromegaly, dwarfism, malnutrition, pituitary disorders, and Laron Syndrome
- •Current or history of any significant diseases involving dementia (e.g., Alzheimer's disease, vascular dementia, etc.)
- •Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable.
- •Current diagnosis or history of chronic kidney disease (creatinine levels \> 1.1 mg/dl for women; \> 1.2 mg/dl for men)
- •Current diagnosis or history of a thyroid-related disorder and/or disease
- •Current diagnosis of liver diseases
- •Current diagnosis of primary hypercholesterolemia (LDL-C 160-189 mg/dl \[4.1-4.8 mmol/l\]; non-HDL-C 190-219 mg/dl \[4.9-5.6 mmol/l\])
- •Current diagnosis of primary hypertriglyceridemia (triglycerides \>150 mg/dl, fasting)
Arms & Interventions
Amino Acid Supplement
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.
Intervention: Amino Acid Supplement
Placebo
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.
Intervention: Placebo
Outcomes
Primary Outcomes
The difference in serum IGF-1 concentrations from baseline up to 60 days of supplementation between Amino Acid Supplement (AAS) compared to placebo.
Time Frame: baseline (day 1) and 61 days
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
The difference in serum IGF-1 concentrations from baseline up to 30 days of supplementation between Amino Acid Supplement (AAS) compared to placebo.
Time Frame: baseline (day 1) and 31 days
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
The difference in serum IGF-1 concentrations from baseline up to 90 days of supplementation between Amino Acid Supplement (AAS) compared to placebo.
Time Frame: baseline (day 1) and 91 days
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
Secondary Outcomes
- Incidence of pre-emergent adverse events following 90 days of supplementation with Amino Acid Supplement (AAS) compared to placebo(105 days)
- Incidence of post-emergent adverse events following 90 days of supplementation with Amino Acid Supplement (AAS) compared to placebo(105 days)