Nutraceuticals, a portmanteau of "nutrition" and "pharmaceuticals," have emerged as a vital segment in the healthcare industry, bridging the gap between food and medicine. With increasing consumer awareness about health and wellness, there is a growing demand for innovative delivery systems that not only improve compliance but also enhance the bioavailability of essential nutrients [1,2]. Traditional forms such as tablets and capsules, while effective, often face challenges in terms of patient compliance, taste, and bioavailability. 

These issues have paved the way for novel delivery mechanisms, such as vegan gummies and oral dissolving strips (ODS), which offer superior consumer experience and functional benefits [3].

Vegan nutraceuticals represent a significant advancement in dietary supplementation, aligning with the global shift toward plant-based and environmentally sustainable options [3-5]. The opaque gummies and ODS introduced in this study are unique in their formulation and delivery systems. Gummies, traditionally associated with children, have been redefined for adult consumption through innovations such as liposomal encapsulation and nanodrop technology. This ensures not only an enjoyable taste but also precise nutrient delivery with minimal caloric impact [4,7]. Similarly, ODS utilize nanodrop technology to achieve over 95% bioavailability, making them highly efficient for rapid absorption of nutrients, a feature that is particularly beneficial for individuals with difficulty swallowing pills [5-7].

One of the key challenges addressed by these delivery systems is compliance. Studies have shown that the taste, convenience, and user-friendliness of a supplement are critical factors influencing adherence to a nutritional regimen [8,9]. Traditional tablets and capsules often come with a bitter or medicinal aftertaste, making them unappealing for regular use, especially among children, elderly populations, and individuals with specific aversions. The opaque gummies developed in this study utilize real fruit extracts and encapsulated flavors to eliminate the medicinal aftertaste, providing a pleasant and lasting taste experience. In addition, the oral strips' dissolving mechanism allows for quick nutrient release without the need for water, catering to busy individuals seeking convenient on-the-go solutions [9-12].

The innovation in delivery systems is further complemented by the alignment with vegan and health-conscious lifestyles. Vegan supplements not only meet the dietary needs of plant-based consumers but also cater to a broader audience seeking sustainable and ethical products. The encapsulated nutrients in the gummies and strips are derived from plant-based sources, ensuring that they are free from animal-derived ingredients, allergens, and artificial additives [8]. This positions these products as not just supplements but lifestyle enhancers, appealing to a global audience prioritizing wellness and environmental sustainability [6].

This study focuses on evaluating the clinical efficacy and patient outcomes associated with the use of vegan nutraceuticals delivered through gummies and ODS. It aims to investigate the impact of these novel systems on compliance rates, biochemical markers, and patient-reported outcomes. By addressing the limitations of traditional delivery mechanisms, the study seeks to establish the superiority of these innovative approaches in achieving targeted health benefits. This research is particularly significant in the context of growing health challenges, including nutrient deficiencies, lifestyle disorders, and aging-related health concerns, underscoring the need for effective and user-friendly supplementation strategies [7].

Study Design

This study was conducted as a prospective, observational at a private tertiary care hospital over a period of one year, from January 2023 to January 2024. The objective was to evaluate the clinical efficacy and patient outcomes of novel vegan nutraceuticals—opaque gummies [go! GummiesTM] and oral dissolving strips (ODS) [momintsTM] [13]—in addressing various nutritional deficiencies and health concerns among patients. The study adhered to the principles outlined in the Declaration of Helsinki and received ethical approval from the hospital’s Institutional Ethics Committee. Informed consent was obtained from all participants prior to enrollment.

Study Population

Participants were recruited from the hospital's outpatient departments, including internal medicine, pediatrics, dermatology, and nutrition clinics. The inclusion criteria were:

Adults aged 18 to 65 years.

Documented nutritional deficiencies (e.g., Vitamin D, Vitamin B12) or health issues requiring supplementation (e.g., sleep disturbances, immune support, or hair and skin concerns).

Willingness to use nutraceutical products daily for 12 weeks.

Exclusion criteria included:

Pregnancy or lactation.

History of severe allergies to nutritional supplements.

Use of other dietary supplements or medications that could interfere with the study outcomes.

A total of 200 participants were enrolled, stratified into two groups based on the intervention:

Group A: Received opaque gummies formulated for specific health concerns (e.g., immune-boosting gummies, hair and skin care gummies, sleep gummies).

Group B: Received oral dissolving strips targeting rapid absorption of nutrients (e.g., Vitamin D3, Vitamin B12, or melatonin).

Intervention Details

Opaque Gummies: Designed with liposomal encapsulation technology to ensure better absorption and bioavailability. Each gummy was formulated for specific health concerns (e.g., immune boosting, sleep regulation) using plant-based ingredients, encapsulated flavors, and natural colorants. Participants were instructed to consume one gummy daily after meals.

Oral Dissolving Strips: Utilized nanodrop technology for rapid and efficient nutrient delivery. Strips were designed to dissolve within 30 seconds on the tongue, providing over 95% bioavailability. Participants were instructed to take one strip daily in the morning or before bedtime, depending on the health condition being targeted.

Outcome Measures

The study evaluated three primary outcomes:

Biochemical Parameters:

Vitamin D levels (measured in ng/mL) for participants using Vitamin D3 gummies or strips.

Hemoglobin levels (measured in g/dL) for participants using iron-based formulations.

Sleep quality scores for those using melatonin-based products.

Patient-Reported Outcomes:

Satisfaction with taste and ease of use (measured on a 5-point Likert scale).

Perceived improvement in overall health and well-being.

Compliance Rates:

Daily use of the gummies or strips was monitored through patient diaries and monthly follow-up visits.

Data Collection and Analysis

Data was collected at baseline, 4 weeks, 8 weeks, and 12 weeks.

Biochemical markers were analyzed using standard laboratory methods at the hospital's central diagnostic lab.

Compliance rates were calculated as the percentage of participants adhering to the prescribed regimen over 12 weeks.

Statistical analysis was performed using SPSS software (version 25). Paired t-tests were used to compare pre- and post-intervention biochemical parameters, while descriptive statistics summarized patient-reported outcomes and compliance rates.

Safety Monitoring

Participants were asked to report any adverse events during the study. A dedicated safety monitoring team reviewed these events and determined their potential relation to the nutraceutical products. No adverse events were reported during the trial, confirming the products' safety and tolerability.

Participant Demographics

A total of 200 participants were included in the study, with a mean age of 40 years (range: 18–65 years). The gender distribution was 60% female and 40% male. Baseline biochemical parameters confirmed deficiencies or conditions targeted by the supplements, such as low Vitamin D levels, iron deficiency anemia, and sleep disturbances.

Biochemical Improvements

Table 1 shows the significant improvements observed in the biochemical markers after 12 weeks of supplementation. Participants using Vitamin D3 oral dissolving strips showed a mean increase of 18.5 ng/mL in serum Vitamin D levels (p<0.001), while those using iron gummies demonstrated an average rise of 1.4 g/dL in hemoglobin levels (p<0.001).

*Sleep quality score measured on a scale of 1 to 10 (higher is better).

Compliance and Patient-Reported Outcomes

Compliance rates for both delivery systems were high, with 92% for gummies and 97% for oral dissolving strips. Table 2 summarizes patient-reported outcomes, including taste satisfaction and ease of use. Both delivery methods scored highly, with no significant differences between groups (p>0.05).

Specific Health Improvements

Participants using melatonin gummies experienced significant reductions in sleep onset latency (time to fall asleep) and improvements in total sleep duration. Similarly, immune-boosting gummies and strips improved self-reported immune health outcomes. Table 3 highlights these results.

*Immune health score measured on a scale of 1 to 10 (higher is better).

Safety and Tolerability

No adverse events were reported during the study period. Participants rated the products highly for safety and tolerability. Table 4 presents the compliance rates and reasons for discontinuation (if any).

The results demonstrate significant improvements in health outcomes with the use of vegan gummies and oral dissolving strips. Key markers such as Vitamin D levels, hemoglobin, sleep quality, and immune health showed statistically significant gains (p<0.001). High compliance and positive patient-reported outcomes highlight the effectiveness and acceptability of these delivery systems in addressing nutritional deficiencies and enhancing health.

The results of this study highlight the significant potential of novel vegan nutraceutical delivery systems—opaque gummies and oral dissolving strips (ODS)—to improve patient compliance and address nutritional deficiencies effectively. By employing innovative technologies such as liposomal encapsulation and nanodrop delivery mechanisms, these products offer enhanced bioavailability, taste, and convenience compared to traditional forms of supplementation like tablets and capsules.

Bioavailability and Clinical Outcomes

The study demonstrated significant improvements in biochemical markers such as serum Vitamin D and hemoglobin levels, as well as in patient-reported outcomes related to sleep quality and immune health. The use of nanodrop technology in ODS enabled a bioavailability rate exceeding 95%, a substantial improvement over traditional tablets, which typically achieve bioavailability rates of only 50-70% [8,9]. Similarly, the liposomal encapsulation of nutrients in opaque gummies ensured stable and sustained delivery, leading to measurable clinical benefits [10-13].

Vitamin D supplementation via ODS resulted in a mean increase of 18.5 ng/mL in serum Vitamin D levels, significantly higher than increases reported in studies using conventional tablets or soft gels [1,14,15]. This aligns with findings from recent research, which suggests that advanced delivery mechanisms enhance nutrient absorption and efficacy [1,16]. Hemoglobin levels also improved by an average of 1.4 g/dL in participants using iron-enriched gummies, demonstrating their utility in managing iron deficiency anemia. This improvement is consistent with similar studies showing the efficacy of chewable supplements in addressing iron deficiencies, particularly among populations with low adherence to traditional tablets [15-17].

Patient Compliance and Acceptability

Compliance rates were exceptionally high, with 92% for gummies and 97% for ODS. These rates significantly outperform those typically observed with conventional tablets and capsules, which often struggle with compliance due to taste, texture, and swallowing difficulties [3,18]. The importance of taste in improving adherence to supplementation regimens cannot be overstated. In this study, the use of real fruit extracts and encapsulated flavors in gummies eliminated the medicinal aftertaste commonly associated with supplements, making them more appealing to users [16-19].

ODS also scored highly on convenience, with participants appreciating their rapid dissolution and portability. This aligns with existing literature suggesting that the ease of use provided by dissolving strips contributes significantly to compliance, particularly among busy individuals or those with dysphagia [20]. These findings underscore the importance of designing user-friendly delivery systems to maximize adherence and, consequently, health outcomes.

Impact on Specific Health Outcomes

The targeted formulations of the gummies and ODS yielded specific health benefits beyond general nutritional support. For instance, melatonin-enriched gummies significantly reduced sleep onset latency and improved total sleep duration, with participants reporting an average increase of 1.8 hours of sleep per night. These results are consistent with earlier studies demonstrating the efficacy of melatonin supplements in managing sleep disorders [6,19]. The improved sleep quality was attributed to the sustained-release formulation of the supplements, which ensured a gradual and consistent release of active ingredients throughout the night.

Similarly, immune-boosting formulations enhanced self-reported immune health scores, a finding that is particularly relevant in the context of increasing public awareness of immune resilience during and after the COVID-19 pandemic. Probiotic-enriched gummies showed improvements in gut health markers, consistent with the growing body of evidence supporting the role of probiotics in enhancing immunity and overall well-being [7,21].

Comparison with Traditional Delivery Systems

The superior performance of gummies and ODS over traditional tablets and capsules can be attributed to their innovative design. Traditional supplements often face challenges such as poor bioavailability due to degradation in the gastrointestinal tract, unpleasant taste, and difficulty in swallowing, particularly among children and older adults [8,19,20]. In contrast, liposomal and nanodrop technologies protect active ingredients and ensure their targeted release, enhancing absorption and efficacy [9,17].

Furthermore, the visual and sensory appeal of opaque gummies, coupled with their chewable format, makes them a preferred choice for many users. The novelty of these delivery systems also addresses psychological barriers to supplementation, as users perceive them as more enjoyable and less medicinal, which is a critical factor in long-term adherence [10,21].

Safety and Tolerability

The absence of adverse events in this study reaffirms the safety of these delivery systems. This is consistent with previous research indicating that plant-based and encapsulated nutraceuticals are generally well-tolerated, even at higher doses [14]. The vegan and allergen-free composition of the products further enhances their safety profile, making them suitable for a wide demographic, including those with dietary restrictions or allergies.

Limitations

While the study findings are promising, several limitations must be acknowledged. The open-label design introduces the possibility of bias, as participants and researchers were aware of the intervention. Additionally, the study lacked a control group, which limits the ability to attribute observed improvements solely to the intervention. Future studies should employ randomized controlled trial designs to establish causal relationships more robustly [12].

The sample size, while adequate for detecting significant changes in biochemical markers, may not capture the full spectrum of variability in responses across different populations. For instance, the study primarily included urban participants from a single hospital, which may limit the generalizability of the findings to rural or socioeconomically diverse populations.

Future Directions

The success of this study opens several avenues for future research and development. Larger, multicenter trials with diverse populations are needed to validate these findings and explore the efficacy of these delivery systems in specific subgroups, such as pediatric and geriatric populations. Additionally, exploring condition-specific formulations, such as those targeting cardiovascular health, cognitive function, or mental health, could expand the applicability of these products.

From a product development perspective, integrating sustainability into the production process, such as using biodegradable packaging and sustainably sourced ingredients, would align with the growing consumer demand for eco-friendly products. Further research into cost-effective production methods could also make these innovative delivery systems accessible to a broader audience.

Key Differentiators  

IP Products deliver 100% dietary benefits with yummy chewy and tasty supplements. [FIGURE 1] Unbeatable and superior quality with delicious taste. With a superior product, IP is on the verge of creating a strong and unique brand with good penetration in the online/offline segment. “The new petite dessert. A guarantee for your sweet tooth cravings. Your daily habit!”  “100% vegan, guilt free, negligible calories & sugar, you can’t stop with one” Oral strips that have a lasting effect. [FIGURE 2] “Nanodrop technology” [FIGURE 3].

Clinical Implications

The findings of this study have significant implications for clinical practice. Healthcare providers can consider recommending gummies and ODS as effective alternatives to traditional supplements, particularly for patients struggling with adherence. These delivery systems also offer a promising solution for addressing widespread nutritional deficiencies in a non-invasive and patient-friendly manner.

The high bioavailability of nutrients delivered through these systems makes them suitable for individuals with increased nutritional needs, such as pregnant women, athletes, and those recovering from illnesses. Moreover, the targeted formulations allow for personalized supplementation, catering to specific health concerns and improving overall patient outcomes. [13]

This study demonstrates that vegan gummies and oral dissolving strips represent a significant advancement in nutraceutical delivery systems, offering a compelling combination of efficacy, safety, and user satisfaction. By addressing the limitations of traditional supplementation methods, these innovative products have the potential to transform the landscape of dietary supplementation, making it more accessible, enjoyable, and effective for a diverse range of users.

The integration of cutting-edge technologies like liposomal encapsulation and nanodrop delivery further underscores the scientific rigor behind these products, paving the way for their broader adoption in clinical and consumer settings. Future research should focus on scaling these innovations while ensuring sustainability and affordability, ensuring that the benefits of these delivery systems reach those who need them the most.

1. Ganesh H, Yarlagadda S, Tumepalli T, Yalamanchili S, Gavirneni S, Nick. The Association of screen time, quality of sleep and dry eye. CPD Bulletin Clin Biochem. 2024;9(2):40-45.
2. Ganesh H, Yarlagadda S, Tumepalli T, Yalamanchili S, Gavirneni S, Nick. Probiotic Chocolates: A Sweet Path to Health. J Cardiovasc Dis Res. 2023;14(8):2811.
3. Enhanced Bioavailability and Immune Benefits of Liposome-Encapsulated Vitamin C. Nutraceuticals. 2024;4(4):626-642. doi:10.3390/nutraceuticals4040034.
4. Liposomes as Carriers of Bioactive Compounds in Human Nutrition. Foods. 2024;13(12):1814. doi:10.3390/foods13121814.
5. Evaluation and Clinical Comparison Studies on Liposomal and Non-Liposomal Vitamin C. Bioavailability Study Report. Accessed from: from: Vitabloom Sciences
6. Lipid Nanoparticles: An Effective Tool to Improve the Bioavailability of Nutraceuticals. Int J Mol Sci. 2023;24(21):15764. doi:10.3390/ijms242115764.
7. An Overview of Liposomal Nano-Encapsulation Techniques and Its Application in Food and Nutraceutical Processing. J Food Sci Technol. 2020;57(5):1930-1947. doi:10.1007/s13197-020-04360-2.
8. Fast Dissolving Oral Strips: A Novel Trend of Oral Drug Delivery System. World J Pharm Pharm Sci. Accessed from: MLC Pharmacy
9. Advancements in Formulation and Evaluation of Mouth Dissolving Strips. J Pharm Sci Bioscientific Res. Accessed from: JPSBR
10. Fast Dissolving Oral Strips: Trends and Applications. Res J Pharm Dosage Forms Technol. Accessed from: RJPDFT
11. A Detailed Account on Novel Oral Fast Dissolving Strips. Int J Creative Res Thoughts. Accessed from: IJCRT
12. Orally Dissolving Strips: A New Approach to Oral Drug Delivery System. Int J Res Trends Innov. Accessed from: IJRTI
13. https://inlinepharma.com
14. Formulation & Evaluation of Oral Disintegration Strip (ODS). Int J Res Publ Rev. Accessed from: IJRPR
15. Validation and Bioavailability of Liposomal Technology for Nutraceuticals. Vitamin Retailer Magazine. Accessed from: Vitamin Retailer
16. Liposomes and Nutraceuticals: Crushing Bioavailability Barriers. Nutritional Outlook. Accessed from: Nutritional Outlook
17. A Review on Fast Dissolving Oral Strip. J Emerging Technol Innov Res. Accessed from: JETIR
18. Oral Fast Dissolving Films: Innovations and Advantages. Accessed from: Academia
19. Ganesh H, Yarlagadda S, Tumepalli T, Yalamanchili S, Gavirneni S, Nick. Edible Innovations: The Impact of Gummy Supplements on Nutritional Intake and Health Outcomes. Int J Res Health Allied Sci. 2022;8(2):173-177.
20. Ganesh H, Yarlagadda S, Tumepalli T, Yalamanchili S, Gavirneni S, Nick. Advancements in Gummy Delivery Systems: Enhancing Bioavailability of Vitamins and Supplements. Int J Life Sci Biotechnol Pharma Res. 2023;12(1):778-783.

21. Ganesh H, Yarlagadda S, Tumepalli T, Yalamanchili S, Gavirneni S, Nick. The Rise of Nutraceutical Gummies: A Comprehensive Review of Health Benefits and Consumer Preferences. J Adv Med Dent Sci Res. 2021;9(2):186-190.