This 28-day study was conducted as an interventional, open label, pilot trial to examine the effects of plant-based melatonin (phytomelatonin) from Somato® tomato extract (Nutraland USA) on key physiological and psychological domains associated with sleep quality, autonomic function, and health-related quality of life (HRQoL). Twenty-two healthy men and women (mean age: 42 years) received 2 mg of phytomelatonin daily from Somato® (a tomato extract). Using a decentralized, real-world evidence (RWE) design, the study integrated objective biometric data from Oura ring wearable devices with validated participant-reported outcomes (e.g., Pittsburgh Sleep Quality Index (PSQI) and HRQoL using Short Form 36 Health Survey (SF-36)) to explore tolerability, early efficacy signals, and mechanistic trends. Results were that supplementation with Somato® phytomelatonin resulted in significant improvement in: sleep latency (33%, PSQI, p=0.005; 11.55%, Oura ring, p-0.016), time awake (Oura ring, 10.08%, p=0.002), sleep efficiency (Oura ring, 1.21%, p=0.011), and the global PSQI score (14.22%, p=0.025). Significant improvement was also demonstrated in HRQoL using SF-36 for emotional well-being (8.22%, p=0.02). Other SF-36 variables showing improvements included: general health (3.22%), energy & fatigue (15.12%), limitations due to emotional problems (15.22%), pain (5.83%), social functioning (6.11%), physical function (2.81%), and limitations due to physical functioning (-9.33%). In conclusion, this pilot study found that 2 mg/day of phytomelatonin from Somato® tomato extract improved physiological and psychological domains associated with sleep quality, autonomic function, and HRQoL. Consequently, conducting a randomized controlled trial with a larger sample size is warranted to confirm beneficial findings demonstrated in the current pilot study.
