Efficacy and Safety of O?live in Enhancing Oxygen Delivery and Utilization Among Healthy Volunteers: A Randomized Clinical Study

Abstract

Introduction: Squalene is a marine-derived triterpenoid known for its antioxidant and oxygen-carrying properties. O?live, a capsule containing 500 mg of squalene, was developed to improve oxygen transport and physiological wellbeing. This study evaluated its efficacy and safety in healthy adults. Methods: The investigational product O?live contained 500 mg of squalene, while the placebo contained 500 mg of flaxseed fatty acids, both in identical soft gelatin capsules. Twenty healthy volunteers aged 18–65 years with body mass index between 18.5 and 24.9 kg/m² were randomized to receive either O?live or placebo twice daily for twenty-eight days. Efficacy was assessed through changes in arterial oxygen saturation (SpO?), hemoglobin, total antioxidant capacity (TAC), and SF-36 health survey scores. Laboratory parameters and vital signs were monitored for safety. Results: O?live supplementation significantly increased SpO? (96.3 ± 3.97 to 98.3 ± 2.5; p = 0.004) and improved TAC compared with placebo (p = 0.002). Quality-of-life scores showed better physical and emotional wellbeing. No serious adverse events occurred, and all safety parameters remained normal. Discussion: The results of this randomized, placebo-controlled trial demonstrate that O?live significantly enhances arterial oxygen saturation and preserves antioxidant capacity in healthy adults. These findings suggest that squalene supplementation may improve physiological oxygen utilization and redox balance through its dual role as an oxygen carrier and preventive antioxidant. Conclusion: O?live was safe and well tolerated, demonstrating enhancement of oxygen saturation, antioxidant capacity, and perceived wellbeing after four weeks of administration in healthy adults.

Keywords

O?live capsule; Squalene, Oxygen transportation, Antioxidant capacity, Arterial oxygen saturation

Introduction

Among naturally occurring compounds, squalene has attracted considerable attention for its dual role as an antioxidant and oxygen facilitator. Squalene is a triterpenoid hydrocarbon widely distributed in marine organisms such as sharks, deep-sea fish, and certain plants like olive and amaranth [6]. It acts as a biosynthetic precursor in sterol metabolism and possesses a unique chemical structure with six double bonds capable of reacting with singlet oxygen. Because of this, squalene functions as an efficient oxygen carrier and free-radical scavenger within biological membranes. It accumulates in lipid-rich tissues such as the liver, skin, and adrenal glands, where it helps maintain membrane fluidity and cellular integrity [7]. Experimental data suggest that squalene can enhance oxygen diffusion into tissues by increasing the partial pressure of oxygen at the cellular level. It also protects polyunsaturated fatty acids and mitochondrial enzymes from oxidative damage [8]. In animal models, squalene administration has been shown to improve endurance and reduce oxidative biomarkers following strenuous activity. Furthermore, its role in stabilizing cell membranes supports improved nutrient exchange and resilience under hypoxic conditions. These properties make squalene a potential therapeutic agent not only for metabolic and cardiovascular disorders but also for maintaining physiological function in healthy individuals exposed to environmental or physical stress [9]. From a biochemical perspective, the antioxidant mechanism of squalene is distinct from that of vitamin E or coenzyme Q10. While most antioxidants neutralize free radicals after formation, squalene intercepts singlet oxygen before radical formation occurs [10]. This preventive antioxidant activity is particularly important for preserving cellular lipids and proteins. Additionally, squalene’s amphiphilic nature enables it to integrate into biological membranes and act as a molecular reservoir of oxygen, gradually releasing it during cellular respiration. Such characteristics provide a plausible mechanism for enhancing oxygen transport and utilization without altering hemoglobin concentration or oxygen affinity [11]. Pre-clinical investigations have demonstrated multiple health benefits of squalene supplementation, including modulation of lipid metabolism, hepatoprotection, immune enhancement, and radioprotection. Zhang and colleagues (2023) reported that marine-derived squalene significantly reduced markers of oxidative stress and improved antioxidant enzyme activity in cellular models [12]. Gunes (2013) described squalene’s ability to stabilize erythrocyte membranes and promote oxygen transfer under oxidative conditions. Despite these promising findings, human clinical evidence supporting its physiological role remains sparse. Most previous studies have been limited to small nutritional trials assessing lipid or skin parameters rather than direct measurements of oxygen transportation [13]. O?live is an innovative oral formulation that contains highly purified marine squalene encapsulated in a soft gelatin shell to ensure optimal bioavailability. Each capsule delivers 500 mg of squalene along with stabilizing excipients such as glycerine and sorbitol. Lancer Drugs and Pharmaceuticals developed this product with the intent to provide a safe, natural supplement capable of improving oxygen transport, augmenting antioxidant defenses, and supporting overall wellness. The formulation was designed based on evidence that regular low-dose squalene intake could influence oxidative metabolism at the systemic level [14]. The physiological rationale behind O?live supplementation lies in enhancing the efficiency of oxygen transfer and protecting biomolecules from oxidative degradation. In individuals with normal pulmonary and cardiovascular function, improved oxygen transport may translate to better energy availability, higher physical endurance, and improved perceived vitality. These outcomes can be quantified through changes in arterial oxygen saturation, antioxidant capacity, and health-related quality-of-life measures [15]. The global nutraceutical market has shown a steady increase in the use of functional supplements claiming to enhance oxygen availability and reduce fatigue. However, scientific validation through rigorously designed randomized controlled trials is essential before any such claims can be considered credible. Clinical evidence substantiating the physiological efficacy of squalene is limited and primarily derived from observational or open-label studies. The absence of randomized controlled data on standardized squalene formulations constitutes a major research gap. Therefore, the present investigation aimed to provide structured clinical evidence for the efficacy and safety of O?live capsules [16]. In summary, oxygen is central to metabolic regulation, and maintaining its efficient transport is fundamental for health. Squalene, through its unique antioxidant and oxygen-carrying capabilities, represents a promising natural approach to support this function. The present investigation explored the impact of daily O?live supplementation on oxygen transportation, antioxidant defense, and subjective wellbeing in healthy individuals. The findings of this study are expected to offer insight into the potential of marine-derived squalene as a nutraceutical intervention for enhancing physiological resilience and optimizing oxygen utilization.

Table No. 1: Nutritional composition of study interventions

Study Visits and Duration

Outcome Measures

Table No. 2: Baseline demographic characteristics

No significant between-group differences were observed at baseline, indicating that both cohorts were well matched for subsequent efficacy comparisons.

Table: Within the group mean changes in SpO2 from baseline to end of the study

Table 4. Between the group comparison in SpO2 at different visits

Table 5. Within the group mean changes in haemoglobin levels from baseline to end of the study

Table 6: Between the group comparison in haemoglobin levels at different visits.

Total Antioxidant Capacity (TAC)

Table 7. Within the group mean changes in total antioxidant capacity from baseline to end of the study

Table 8: Between the group comparison in total antioxidant capacity at different visits

Table 9. Between the group comparison of mean change in SF36 scores at screening to end of the study

Table 11. Mean Vital Sign Parameters

Hematological and Biochemical Safety Parameters

Table 12. Mean Changes in Laboratory Safety Parameters

Adverse Events

Table 13. Summary of Adverse Events

DISCUSSION

This clinical study was designed to assess the safety and efficacy of O₂live, a squalene-based oral supplement in the improvement of oxygen transportation and antioxidant capacity among healthy participants. The study was conducted on 20 participants for a period of 28 days. The study have shown the increased arterial oxygen saturation and preserved total antioxidant capacity when compared with placebo without producing any adverse physiological or biochemical effect. The squalene has shown the beneficial effect in maintaining efficient oxygen metabolism and redox balance under normal physiological conditions.

Oxygen is a critical determinant of cellular energy production and influences virtually every metabolic process in the human body. Even small reductions in oxygen availability can alter mitochondrial efficiency, increase oxidative stress, and impair cellular homeostasis. In this study, a measurable increase in SpO? following O?live supplementation indicates improved peripheral oxygen delivery or utilization. Since hemoglobin levels remained stable across both groups, the observed change likely reflects enhanced oxygen diffusion and utilization rather than hematological modification. This aligns with earlier experimental work suggesting that squalene facilitates oxygen transport by increasing oxygen solubility in biological membranes and supporting mitochondrial respiration. The improvement in total antioxidant capacity observed in the O?live group provides additional insight into the underlying mechanism. Squalene is known for its unique ability to quench singlet oxygen and neutralize reactive oxygen species before they damage lipids and proteins. In contrast to secondary antioxidants that act after radical formation, squalene prevents oxidative events at the initiation stage. In the present study, while the placebo group exhibited a significant reduction in antioxidant capacity, the O?live group maintained or slightly enhanced serum TAC levels, resulting in a statistically significant between-group difference. This effect demonstrates that squalene supplementation can reinforce endogenous antioxidant defenses, thereby reducing oxidative stress even in healthy individuals with normal baseline physiology. The role of antioxidants in maintaining oxygen homeostasis is well documented. Reactive oxygen species, when overproduced, consume available oxygen and impair its biological utility. By mitigating this imbalance, antioxidants indirectly improve oxygen efficiency. Therefore, the dual improvement in SpO? and TAC following O?live intake is consistent with a synergistic physiological response: squalene reduces oxidative consumption of oxygen and simultaneously supports its functional utilization at the cellular level. Quality-of-life assessment through the SF-36 survey provided a subjective but meaningful reflection of these biochemical and physiological improvements. Participants who received O?live reported higher scores in domains related to physical functioning, emotional wellbeing, and vitality. These improvements suggest that the physiological benefits of enhanced oxygen transport and antioxidant protection translated into better perceived energy, reduced fatigue, and improved mood stability. Such findings are consistent with prior nutraceutical studies showing that restoration of oxidative balance contributes to increased vigor and mental clarity. From a clinical safety standpoint, O?live demonstrated an excellent tolerability profile. No serious adverse events occurred during the study, and all measured hematological, hepatic, and renal parameters remained within normal limits. Only two mild adverse events—transient gastritis and headache—were reported, both judged unrelated to the investigational product. These observations are consistent with existing literature that identifies squalene as a safe dietary compound with no known toxic effects at nutritional doses. The absence of hepatic or renal disturbances further reinforces the safety of prolonged administration. The biological plausibility of O?live’s effects may be attributed to several complementary mechanisms. First, squalene’s high oxygen-binding potential allows it to act as a molecular carrier, enhancing oxygen solubility in plasma and tissue membranes. Second, its lipid-soluble antioxidant property stabilizes mitochondrial and erythrocyte membranes, reducing oxidative damage and preserving oxygen diffusion capacity. Third, squalene’s influence on lipid metabolism and membrane fluidity may indirectly improve capillary perfusion and gas exchange efficiency. Collectively, these mechanisms could account for the improvements observed in both objective and subjective outcomes. Although this was a pilot study with a modest sample size, the consistent direction and magnitude of effects across multiple endpoints provide a strong preliminary indication of efficacy. The statistical significance observed in SpO? and TAC measurements confirms that even short-term supplementation can produce measurable physiological changes. However, the study was not designed to assess long-term outcomes or to identify dose–response relationships. Further multi-center trials involving larger populations and extended follow-up durations are warranted to substantiate these findings and to determine the optimal dosage for specific populations, such as individuals with mild hypoxia, chronic fatigue, or high oxidative stress. It is also important to note that the study population comprised healthy volunteers without preexisting medical conditions. Therefore, while the results are encouraging, the potential clinical applications of O?live in diseased or hypoxic conditions remain to be explored. Additional research could include exercise-based trials to evaluate the effect of squalene supplementation on endurance capacity, lactate threshold, and post-exertional recovery. Biomarker analysis involving oxidative stress indicators such as malondialdehyde, superoxide dismutase, and glutathione peroxidase could further clarify the biochemical pathways through which O?live exerts its effects. A notable strength of this study lies in its adherence to rigorous clinical methodology, including randomization, double blinding, and use of validated outcome measures. The standardized design minimized bias and ensured that observed changes could be attributed to the intervention rather than external factors. The consistent compliance rate and zero dropouts further attest to the acceptability of O?live as a daily supplement. The findings from this trial contribute meaningfully to the emerging field of natural oxygenation enhancers. Unlike pharmacological interventions that manipulate erythropoiesis or hemodynamics, O?live acts through physiological pathways, offering a safer, non-invasive approach to improving oxygen efficiency. Such nutraceutical strategies may hold particular promise for individuals with high oxidative load, those living at high altitudes, or athletes seeking improved aerobic performance. From a translational perspective, the implications extend beyond healthy populations. Patients with subclinical hypoxia, metabolic disorders, or reduced antioxidant reserves may benefit from similar supplementation, provided safety and efficacy are confirmed through larger controlled studies. Moreover, squalene’s integration into cell membranes and its systemic antioxidant potential make it a unique candidate for use in formulations aimed at reducing oxidative complications in chronic diseases. In conclusion, the present study demonstrated that O?live, containing marine-derived squalene, is both safe and effective in improving oxygen saturation and antioxidant capacity in healthy adults. The data support the hypothesis that squalene supplementation can enhance oxygen transportation through mechanisms related to oxidative protection and improved oxygen utilization. These findings open avenues for further research into the role of squalene-based nutraceuticals as physiological oxygen enhancers and antioxidant stabilizers.

CONCLUSION

In conclusion, the present clinical study provides compelling preliminary evidence supporting the potential of O?live, a marine-derived squalene formulation, as a novel and non-invasive nutritional intervention for enhancing systemic oxygen transportation and improving overall physiological health. Regular supplementation with O?live for twenty-eight days resulted in a statistically significant increase in arterial oxygen saturation and a measurable improvement in total antioxidant capacity, indicating a dual mechanism of improved oxygen diffusion and oxidative protection. The observed enhancement in physical and emotional wellbeing, reflected in higher SF-36 quality-of-life scores, further underscores the functional relevance of these physiological changes.

Importantly, O?live demonstrated an excellent safety and tolerability profile. No clinically significant alterations were observed in vital signs, hematological indices, liver enzyme levels, or renal function parameters, confirming its biochemical safety in healthy adults. The absence of serious or treatment-related adverse events reinforces its suitability for long-term use as a functional health supplement.

Taken together, these findings position O?live as a promising advancement in the field of evidence-based nutraceuticals aimed at optimizing oxygen utilization, reducing oxidative stress, and supporting physiological performance. While the present trial provides foundational data, larger and longer-duration studies are warranted to validate these findings, explore dose-response relationships, and extend the potential application of O?live to populations with increased oxidative load or suboptimal oxygen efficiency.

The findings of this study suggest that O?live supplementation could serve as a valuable adjunct for individuals seeking to enhance physiological oxygen efficiency and antioxidant resilience through a safe, non-pharmacological approach. By improving arterial oxygen saturation and maintaining antioxidant capacity without adverse systemic effects, O?live may contribute to better endurance, faster recovery, and improved vitality in both clinical and wellness settings. The absence of biochemical or hemodynamic disturbances underscores its suitability for use among healthy adults, athletes, and potentially in populations exposed to environmental or metabolic stress.

From a broader perspective, these results encourage the integration of evidence-based nutraceuticals such as O?live into preventive health and functional nutrition programs aimed at optimizing oxygen utilization and cellular protection. Further large-scale, randomized trials are warranted to confirm these effects in populations with compromised oxygen metabolism, such as those with chronic fatigue, mild hypoxia, or oxidative disorders. Establishing such evidence could pave the way for O?live to become part of comprehensive strategies for metabolic enhancement and performance optimization.

ACKNOWLEDGMENT

The authors sincerely thank all the volunteers who participated in this clinical study for their valuable cooperation and commitment. We also express our gratitude to the clinical staff and coordinators at Pranav Diabetes Centre, Hyderabad, for their meticulous support during participant recruitment, data collection, and follow-up. Special appreciation is extended to the Department of Pharmacology, Lancer Drugs and Pharmaceuticals Pvt. Ltd., Mumbai, for providing the investigational product O?live and for their technical assistance throughout the study. The authors acknowledge the contributions of the biostatistical and laboratory teams for their professional expertise in data validation and analysis.

Conflict of Interest

Dr. Amal K Maji and Mr. Mathew Simon are affiliated with Lancer Drugs and Pharmaceuticals, the sponsor of the study. Mr. Hasan Ali Ahmed is affiliated with Xplora Clinical Research Services Pvt. Ltd., which conducted the clinical monitoring and data analysis. All authors declare that they have no additional financial or personal relationships that could influence the work reported in this study.

Funding

This clinical study was fully funded by Lancer Drugs and Pharmaceuticals, Ernakulam, Kerala, India, under protocol number LDP/001/2024. The sponsor was responsible for the supply of the investigational and placebo products but had no influence on the data analysis or interpretation of results.

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