Effects of Somato® TOMATO Fruit Extract on Key Physiological and Psychological Domains Associated with Sleep Quality, Autonomic Function, and Health-Related Quality of Life: A Pilot Study.

Objective: This 28-day pilot study aimed to evaluate the effects of plant-based melatonin (phytomelatonin) derived from Somato® tomato fruit extract (Nutraland USA) on key physiological and psychological domains associated with sleep quality, autonomic function, and health-related quality of life (HRQoL). Methods: Thirty-five healthy men and women (mean age: 42 years) were enrolled in a decentralized, open-label, real-world evidence study. Participants consumed 2 mg of phytomelatonin daily from Somato® oral strips for 28 days. Objective biometric data were collected using Oura Ring wearable devices. Validated participant-reported outcomes (e.g., Pittsburgh Sleep Quality Index (PSQI) and Short Form 36 Health Survey (SF-36)) helped to explore perceived tolerability, early efficacy signals, and mechanistic trends in a healthy adult population. Results: Twenty-two participants completed the study and were included in the final analysis. Compared to baseline, supplementation with Somato® tomato fruit extract significantly improved percentage change of sleep latency (-33%, PSQI, P = .005; -11.55%, Oura ring, P = .016), time awake (Oura ring, -10.08%, P = .002), sleep efficiency (Oura ring, -1.21%, P = .011), and global PSQI score (-14.22%, P = .025). A significant improvement was also noted in emotional well-being (8.22%, P = .02) based on the SF-36 health-related quality of life questionnaire. Other SF-36 variables also showed improvements that did not reach statistical significance, including general health (3.22%), energy & fatigue (15.12%), limitations due to emotional problems (15.22%), pain (5.83%), social functioning (6.11%), and physical function (2.81%). Conclusion: Supplementation with 2 mg/day of phytomelatonin from Somato® tomato fruit extract improved both physiological and psychological measures associated with sleep quality, autonomic function, and health-related quality of life. These findings support the feasibility of phytomelatonin as a plant-based sleep aid and warrant further investigation in a larger, randomized controlled trial. Keywords: tomato, melatonin, phytomelatonin, sleep latency, sleep efficiency, Pittsburgh Sleep Quality Index, Short Form 36 Health Survey, Oura ring, emotional well-being, energy, fatigue, pain, social functioning, physical function.