Effects of a Natural Carotenoid Complex (CaroRite) on Psychological Well-Being and Oxidative Stress: A Randomized, Double-Blind, Placebo-Controlled Trial

Shalini Srivastava,1 Pravin Kamble,2 Praphulla Kisanrao Awate,3 Ketan Ravindra Kshirsagar,4 Rajesh Mohan Kewalramani,5 Syona Neeraj1 1Research & Development Department, BioAxion Innovations, Mumbai, MH, India; 2Administration, Saikrupa Hospital, Pune, MH, India; 3Administration, Dr. Praphulla Awate’s Clinic, Mumbai, MH, India; 4Administration, Sangvi Hospital, Pune, MH, India; 5Administration, The Kewalramani Clinic, Mumbai, MH, IndiaCorrespondence: Shalini Srivastava, Head of Research & Development, BioAxion Innovations, Mumbai, Maharashtra, India, Tel +91 9619477885, Email dr.shalini@bioaxion.comBackground: Stress significantly influences mental and physical well-being with crucial markers implying the correlation. Carotenoids have been associated with immunomodulatory and protective functions against oxidative stress. Their ability to interact with nuclear factors helps enhance the expression of antioxidative enzymes, leading to the attenuation of these markers. They also curb inflammatory effects of neurodegeneration through microglial activation.Purpose: The study explored the effects of CaroRite (Research Code – CAR), a mixed carotene compound on the levels of oxidative stress markers, mental and physical well-being and quality of life.Patients and Methods: In this randomized trial, 77 males and females, aged 18 to 60 years, were allocated to the investigational product (IP) or the placebo arm. The participants received one capsule of IP (28 mg)/placebo daily for 90 days. The impact on psychological well-being was measured through the Psychological General Well-Being Index, whereas the effects on oxidative stress and immunity were measured through the 8-Isoprostane and Immunoglobulin-A (IgA). Data have been analysed using ANCOVA and paired/unpaired t test.Results: Both the groups, namely the IP and the placebo, were statistically similar in the age, body mass index (BMI) and PGWBI score at baseline (p> 0.05). At Day 90, a significant increase in total PGWBI scores of 3.09 and 2.73 from baseline (p < 0.05) was observed in the CAR and placebo group subsequently, although the change between the groups was not significant. Post-hoc age stratified analysis revealed a statistically significant increase in the scores among older CAR recipients (p = 0.045) as compared to placebo with a moderate effect size (Cohen’s D = 0.7886). In the younger population, a higher non-significant reduction was observed in serum 8-isoprostane in the CAR group compared to the placebo group (p > 0.05) with the small to moderate intervention effect size (Cohen’s d = 0.3444). A non-significant increase was observed in sIgA levels in the CAR group as compared to placebo (p > 0.05) suggesting potential immunomodulatory benefits. CAR was well tolerated, with no adverse effects reported.Conclusion: The results indicate that CAR could be helpful in enhancing psychological health in older individuals. The decline in the levels of oxidative stress in the younger population suggests that CAR may render antioxidative effects, consequently managing psychological well-being.Keywords: carotenoids, oxidative stress, psychological wellbeing, immunoglobulin A, 8-isoprostane, Bio-gen