The Efficacy and Safety of an Amino Acid Supplement in Adults

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

Or,

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)
• Vasectomy of partner at least 6 months prior to screening
• Provided voluntary, written, informed consent to participate in the study.
• Agrees to maintain current lifestyle habits throughout the study, including medications, supplements, and sleep.
• Agrees to avoid taking new supplements.
• Willingness to complete study assessments, journals, and all clinic visits
• Deemed eligible to participate as determined by medical history, laboratory results, and physical exam as assessed by QI

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)
• Current diagnosis of stage 2 hypertension (> 140/90 mmHg)
• Current diagnosis of type 1 or type 2 diabetes mellitus (HbA1c > 6.5%)
• History or presence of gastrointestinal (including prior bariatric bypass surgery), hepatic or renal disease, or any other condition that may interfere with the absorption, distribution, metabolism, or excretion of IPs, based on the opinion of the QI
• History of cardiovascular disease and/or significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
• History (within past two years at screening) or presence of diagnosis of alcohol abuse, a substance abuse disorder, known drug dependence, or seeking treatment for alcohol or substance abuse related disorder.
• Current use of prescribed medications, over-the-counter (OTC) medications, or supplements which may affect the efficacy and/or safety of the IP
• Individuals who work or plan to work night shifts
• Individuals who have travelled to other time zones within two weeks prior to baseline or plan to travel to other time zones during the study
• Alcohol intake average of > 2 standard drinks per day as assessed by the QI
• Clinically significant abnormal laboratory results at screening as assessed by the QI
• Participation in other clinical research studies 30 days prior to enrollment will be assessed on a case-by-case basis by the QI
• Individuals who are unable to give informed consent
• Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant