Mechanism for the Increase in Human Growth Hormone with Administration of a Novel Test Supplement and Results Indicating Improved Physical Fitness and Sleep Efficiency

H uman growth hormone (hGH) is produced and secreted by the pituitary gland in a pulsatile manner; the majority of hGH is released at night.1–3 hGH promotes longitudinal growth in children and influences many other homeostatic functions throughout life, including puberty, body composition, metabolism, physical fitness, and sleep.1,4,5 hGH deficiency (GHD) is a rare disorder characterized by inadequate hGH secretion that occurs in children and adults.6,7 In children, the primary symptoms of GHD are severe short stature and delayed puberty. In adults and children, GHD is associated with low muscle mass, increased adiposity (especially visceral adiposity), decreased bone density, impaired exercise capacity, sleep disturbance, fatigue, impaired lipid metabolism, insulin resistance, infertility, anxiety and depression, and decreased quality of life.6–8 Recombinant hGH replacement is used to increase stature in children with GHD or growth disorders.1,9 In adults with GHD, recombinant hGH replacement improves body composition, exercise performance, bone density, and quality of life.1,6,7,10–15 Recombinant hGH treatment is also used to treat other disorders associated with short stature and HIV wasting syndrome.1 In healthy individuals, hGH levels decrease throughout the lifespan.16 Low levels of hGH have been observed in nonGHD adults, including elderly adults16 and postmenopausal women.17 Low hGH has also been observed in conditions including obesity,18 fibromyalgia,19,20 post-traumatic stress disorder,21 female and male infertility,22,23 impaired sleep,24,25 and low muscle mass (e.g., sarcopenia).26 Treatment with recombinant hGH is not indicated in non-GHD individuals, thus, there is a need for safe therapies that improve endogenous hGH secretion and symptoms associated with low hGH. We recently reported results of a placebo-controlled crossover clinical trial in which a single oral administration of *Current affiliation: Centre for Translational Data Science and Northern Clinical School, University of Sydney, Sydney, Australia. Manuscript received 18 May 2020. Revision accepted 6 September 2020. Address correspondence to: Frank L. Greenway, MD, Pennington Biomedical Research Center, 6400 Perkins Road, Baton Rouge, LA 70808, USA, E-mail: way@ JOURNAL OF MEDICINAL FOOD J Med Food 24 (6) 2021, 653–659 # Mary Ann Liebert, Inc., and Korean Society of Food Science and Nutrition DOI: 10.1089/jmf.2020.0109 65