Effects of a mixed herbal and fruit dietary supplement shot on antioxidant status, oxidative stress parameters, skin parameters, and safety profiles in middle-aged women: A randomized, double-blind, placebo-controlled trial

BACKGROUND: Middle-aged women experience hormonal fluctuations and reproductive transitions that accelerate menopausal symptoms, tissue degeneration, and skin aging due to an imbalance between antioxidant defenses and reactive oxygen species. Enhancing antioxidant defenses may mitigate oxidative stress and maintain skin health. OBJECTIVE: This study aims to investigate the effects of a mixed herbal and fruit dietary supplement shot (HERB) on antioxidant status, oxidative stress, skin assessments, and safety profiles in middle-aged women over 12 weeks. METHODS: In this 12-week randomized, double-blind, placebo-controlled trial, 30 participants received either HERB or placebo (PLA). Primary outcomes were antioxidant status and oxidative stress parameters. Skin parameters and safety profiles were also assessed. Data were analyzed using intention-to-treat and per-protocol approaches. Between-group comparisons were conducted using ANCOVA adjusted for baseline or Student's t-tests. RESULTS: At Week 12, the HERB intervention significantly increased superoxide dismutase (SOD) activity (mean difference = 7.99 U/L; 95% CI: 1.29 to 14.70; p-value = 0.0212) and reduced porphyrin intensity (mean difference = -44.56; 95% CI: -76.06 to -13.60; p-value = 0.0073) compared to PLA. Other antioxidant, oxidative stress, and skin parameters showed no significant changes. Safety profiles remained within reference ranges. Gastrointestinal disturbance occurred more frequently in the PLA group (8 participants in the PLA group vs. 1 participant in the HERB group, p-value = 0.0142). Menstrual disturbances occurred equally (3 participants per group). All adverse events were mild and self-resolved without any medical treatment. CONCLUSION: Intervention with HERB for 12 weeks resulted in higher SOD activity and lower facial porphyrin intensity when compared to PLA, while the other measured antioxidant and skin parameters did not differ between groups. The intervention was well tolerated. These findings should be interpreted with caution due to the small sample size and the limited extent of observed effects. Larger and longer trials are required to confirm these results. This clinical trial was registered with the Thai Clinical Trials Registry (TCTR20241103003).