SUN-439 Improvement in Insulin-Like Growth Factor-1 and Clinical Symptoms: Results of an Open-Label, Single-Arm Study of a Human Growth Hormone-Enhancing Amino Acid Supplement

SeroVital is an orally-administered amino acid supplement that promotes hGH secretion via suppression of somatostatin. We investigated if daily administration of the supplement would increase levels of endogenous insulin-like growth factor 1 (IGF-1), a primary mediator of the effects of hGH, and improve symptoms related to low-normal hGH production in a cohort of individuals being treated for fibromyalgia, a complicated condition associated with endocrine features including low or low-normal hGH. This open-label, single-arm study investigated the effects of 24 weeks of daily oral administration of the supplement in individuals with low-normal hGH production (between the 15th and 50th percentile for age-appropriate levels of IGF-1). The primary endpoint was the change from baseline to endpoint (Week 24) in serum IGF-1. Additional endpoints included the change in body weight, clinical symptoms (assessed with the Revised Fibromyalgia Impact Questionnaire [FIQR], range 0-100, and Perceived Stress Scale [PSS], range 0-40), fasting cardiometabolic markers, tolerability, and safety. Participants continued to receive standard care. The study enrolled 45 adults with mean baseline age (mean±SD) 67±11 years, 67% female, BMI 31±7 kg/m2, and IGF-1 107±28 ng/mL. High mean±SD baseline FIQR and PSS scores of 82±14 and 35±3, respectively, indicated poor to moderate control of fibromyalgia with standard care. All individuals completed 24 weeks of treatment. There was an increase in serum IGF-1 levels at Week 12 that was sustained to endpoint, resulting in a mean±SE Week 24 change of 32.1±2.8 ng/mL (paired t-test p<0.001). IGF binding protein-3 (IGFBP-3) levels were unchanged from baseline (p=ns), indicating no change in IGF-1 sensitivity. There was a steady reduction in body weight that resulted in Week 24 mean±SE change of -6.4±0.4 kg (p<0.001). The change from baseline in FIQR and PSS scores were -25.6±1.6 and -21.5±0.5, respectively (both p<0.001), indicating a substantial improvement. Statistically significant improvements from baseline were also observed for systolic and diastolic blood pressure, HbA1c, LDL and HDL cholesterol, and triglycerides (all p<0.001). The supplement was well tolerated; no adverse events were reported. In patients being treated for fibromyalgia with low-normal hGH production, daily addition of the hGH-enhancing supplement for 24 weeks produced an increase in IGF-1 with associated weight loss and improvements in cardiometabolic markers and clinical symptoms. Sustained augmentation of IGF-1 with the supplement may represent a unique method of improving clinical symptoms in individuals with low-normal hGH, including otherwise healthy adults exhibiting low-normal hGH production.This was an independent investigator-initiated study. Sierra Research Group provided some samples of the supplement.