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DHA TRIGLYCERIDE IN OCULAR SURFACE
Throughout the period 2012 to 2014, we have sponsored several clinical studies in groups of patients suffering dry eye for various reasons that have allowed us to demonstrate the beneficial effects of DHA triglyceride in this disease. In all cases, supplementation has been carried out with dosages of between 700 and 1000 mg/day for 90 days.
- 1. Patients with moderate dry eye in which clinical variables and oscillations in the expression of cytokines in reflex tears are analyzed. There is significant improvement of all studied variables.– Pinazo-Durán MD, et al; Effects of a nutraceutical formulation based on the combination of antioxidants and ω-3 essential fatty acids in the expression of inflammation and immune response mediators in tears from patients with dry eye disorders; Clinical Int Aging 2013; 8:139-148.
- 2. Non-comparative intervention study, carried out on 905 patients suffering from moderate dry eye, in which the evolution of the clinical variables is analyzed. There is significant improvement of all studied variables.– Oleñik A, et al; Effectiveness and tolerability of dietary supplementation with a combination of omega-3 polyunsaturated fatty acids and antioxidants in the treatment of dry eye symptoms: results of a prospective study; Clinical Ophthalmology 2014:8 169–176.
- 3. Non-comparative intervention study, carried out on 1,419 patients suffering from moderate dry eye, in which the evolution of the clinical variables is analyzed. There is significant improvement of all studied variables.– Gatell-Tortajada J, et al; Oral supplementation with a nutraceutical formulation containing omega-3 fatty acids, vitamins, minerals, and antioxidants in a large series of patients with dry eye symptoms: results of a prospective study; Clin Int Aging 2016; 11:571-578.
- 4. Randomized, comparative, and interventional study in patients with glaucoma suffering dry eye symptoms derived from the chronic use of topical antiglaucomatous drugs. The evolution of the clinical variables and the expression of cytokines in reflex tears are analyzed. There is significant improvement of all studied variables.– Galbis-Estrada C, et al; Patients undergoing long-term treatment with antihypertensive eye drops responded positively with respect to their ocular surface disorder to oral supplement with antioxidants and essential fatty acids; Clin Int Aging 2013; 8:711-9.
- 5. An open, non-comparative, intervention study conducted on 1,255 patients suffering from glaucoma and dry eye symptoms resulting from the chronic use of topical antiglaucomatous medications. The evolution of the clinical variables is analyzed. There is significant improvement of all studied variables.– Tellez-Vazquez J, et al; Omega-3 fatty acid supplementation improves dry eye symptoms in patients with glaucoma: results of a prospective multicenter study; Clin Ophthalmol 2016; 10:617-626.
- 6. Comparative and intervention study carried out on intensive users of computer screens in which the evolution of clinical variables and the expression of cytokines present in reflex tears are analyzed. There is significant improvement of all studied variables.– Ribelles A, et al; Ocular Surface and Tear Film Changes in Older Women Working with Computers; BioMed Research International 2015; Article ID 467039.
- 7. Randomized, double-blind, placebo-controlled study of patients suffering from posterior blepharitis with meibomian gland dysfunction. The evolution of the clinical variables and the quality of life of the patients is analyzed. There is significant improvement of all studied variables.- Oleñik A, et al; A randomized, double-masked study to evaluate the effect of omega-3 fatty acids supplementation in meibomian gland dysfunction; Clinical Interventions in Aging 2013; 8:1133–38.– Oleñik A, et al; Benefits of Omega-3 fatty acid dietary supplementation on health-related quality of life in patients with Meibomian Gland Disfunction; Clinical Ophthalmol 2014; 8:831-836.
- 8. Comparative, randomized, intervention study to investigate the influence of DHA supplementation on the tear metabolomics in patients suffering dry eye. Dry eye is inducing changes in the tear metabolic profile that can be modified with ap¬propriate oral supplementation with antioxidants and essential polyunsaturated fatty acids.– Carmen Galbis-Estrada, et al; A metabolomic approach to dry eye disorders. The role of oral supplements with antioxidants and omega 3 fatty acids; Molecular Vision 2015; 21:555-567.READ ORIGINAL STUDIES El papel de la suplementación con antioxidantes y ácidos grasos Omega-3.)
Read original studies - 9. Controlled, randomized, and intervention study to investigate the antioxidant and anti-inflammatory influence of DHA triglyceride supplementation in patients with Keratoconus.– Cristina Peris, et al; Antioxidant and Anti-Inflammatory Effects of Oral Supplementation with a Highly-Concentrated Docosahexaenoic Acid (DHA) Triglyceride in Patients with Keratoconus: A Randomized Controlled Preliminary Study; Nutrients 2023, 15, 1300.
In studies 1, 4 and 6, after 90 days of supplementation, statistically and clinically significant beneficial effects were obtained: with improvement in tear stability (BUT Tear Breakup Time), improvement in the degree of hydration of the ocular surface (Schrimer’s test), an evident and significant reduction in the bothersome symptoms of dry eyes (OSDI validated questionnaire), a reduction in the expression of inflammatory markers (cytokines) present in the reflex tear, an improvement in the redness of the eyelid margin and in the quality of meibomian lipid expression in patients with meibomian dysfunction, and an improvement in quality of life (Study 7). In the clinical intervention study done with 905 patients diagnosed of suffering dry eye users of artificial tears, but who did not reach full satisfaction, after 90 days of supplementation, a significant improvement was again obtained in all clinical parameters (BUT and T. Schirmer) and symptomatological (OSDI), as well as a reduction in the frequency of instillation of the artificial tears. The level of satisfaction assessed by the patients and the ophthalmologist exceeds 80% satisfied or very satisfied (Study 2). Other studies carried out by other researchers with omega-3 fatty acid supplementation, including the one carried out in patients undergoing PRK refractive surgery (study 9), confirm our results. It is quite clear that the diet enriched with DHA Triglyceride provides clear benefits for this group of patients in whom artificial tears are not enough to relieve their discomfort.
Ojo seco inflamado
DHA TRIGLYCERIDE IN GLAUCOMA
In the area of glaucoma, we have participated in three clinical studies, and there is currently a fourth study underway whose preliminary results will be presented at the ARVO congress in 2022.
- 1- This is an other non-comparative open prospective interventional clinical study, in which have been recruited 1255 patients diagnosed of suffering primary glaucoma, but also ocular dryness derived from the use of topical hypotensives. After the administration of 1g/day of DHA Triglyceride (3 capsules of BRUDYPIO) for 90 days, we have been able to observe a highly significant improvement (P<<001) in all the subjective symptoms of dryness: itching, stinging, sensation of grittiness, pain , hyperemia, blurred vision, sensation of friction and palpebral heaviness, as well as a significant improvement of all the objective signs analyzed: Oxford, BUT and Schirmer; there is even a slight, but significant reduction in the IOP level (P<<0.01), possibly related to an improvement in compliance with hypotensive treatment (probably due to a better topical tolerance to it). 82% of patients report being satisfied (60%) or very satisfied (21.9%), compared to 18% dissatisfied. 88% of the ophthalmologists report an improvement (56.4%) or a great improvement (31.3%), compared to 12% who do not appreciate any improvement.- Tellez-Vazquez J, et al; Omega-3 fatty acid supplementation improves dry eye symptoms in patients with glaucoma: results of a prospective multicenter study; Clin Ophthalmol 2016; 10:617-626.
- 2- In a previous comparative interventional clinical study that has included a smaller sample of patients diagnosed with primary glaucoma, we were able to verify equivalent results, as well as a significant reduction in the levels of cytokines present in the tear comparing the levels prior to supplementation and those obtained after a period of 90 days of supplementation with 1g/day of DHA (3 capsules of BRUDYSEC)..- Galbis-Estrada C, et al; Patients undergoing long-term treatment with antihypertensive eye drops responded positively with respect to their ocular surface disorder to oral supplement with antioxidants and essential fatty acids; Clin International Aging 2013; 8:711-9.
- 3- In another clinical study recruiting 47 patients affected by secondary Pseudoexfoliative Glaucoma, randomized 1:1 to receive and not receive 1g/day of DHA Triglyceride (BRUDYPIO 3 capsules) for 6 months, we have not seen significant differences in the clinical variables studied, such as visual acuity and the thickness of the peripapillary layer of nerve fibers analyzed by OCT. But we have seen significant improvements in IOP levels in both eyes (despite having a well-controlled IOP), as well as significant improvements in the oxidative protection of these patients, with an increase in the Total Antioxidant Capacity, a reduction in the peroxidation of plasmatic lipids, an increase in the erythrocyte membrane concentration of DHA, and a reduction in the Omega-6/Omega-3 index, as well as a significant reduction in the plasmatic expression levels of IL-6. – Stéphanie Romeo, et al; Effects of oral supplementation with Docosahexaenoic acid (DHA) plus antioxidants in Pseudoexfoliative glaucoma: a 6-month open-label randomized trial; Journal of Ophthalmology 2018; Article ID 8259371.
- 4- Study on the evolution of visual fields in patients with primary glaucoma treated with antiglaucoma agents to which dietary supplementation is added. Patients are randomized into 4 arms that are supplemented for 3 months: Vitamin C (500mg/day), DHA Triglyceride (1000mg/day), Citicoline (500mg/day) and DHA Triglyceride + citicoline at the same individual daily doses. Significant improvements in visual fields are seen only in the group supplemented with DHA triglyceride + Citicoline together.– Autores: Dr. Alfonso Antón; The Effect of Oral Citicoline and Docosahexaenoic Acid on the Visual Field of Patients with Glaucoma: A Randomized Trial; Life 2022, 12, 1481.
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All this indicates a clear contribution of supplementation to reduce either oxidative stress and the intraocular pressure, which can be associated to the hypotensive effect of obtained with the administered antiglaucomadrugs.
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Ojo seco inflamado
DHA TRIGLYCERIDE IN DIABETIC RETINOPATHY
In the area of diabetic retinopathy, we have carried out three controlled intervention studies with follow-ups of 3 months and up to 2 and 3 years.
- 1- We have carried out a randomized and controlled single-blind study, with a three-year follow-up, to verify the effectiveness of intravitreal Ranibizumab combined with a dietary supplement rich in triglyceride Docosahexaenoic Acid (DHA) plus antioxidants in 62 patients suffering Diabetic Macular Edema. Both groups are administered Ranibizumab IV, a monoclonal antibody directed at destroying Vascular Endothelial Growth Factor (VEGF). Only one of the two randomization groups (50%) received 1g/day of DHA triglyceride (3 capsules of BRUDYRETINA daily), throughout the 3 years of follow-up. It can be seen that the difference between groups in the reduction of Central Macular Thickness (measured with OCT) has been significant in favor of the group supplemented with DHA, already from the first month and up to the total period of 36 months (95% Confidence Interval difference 7.20 – 97.656; P=0.024) despite the fact that the improvement in best-corrected visual acuity measured with the ETDRS optotype does not reach statistical significance 95% -0.22 – 7.09, P<0.066), But it has been seen that the gains of >5 and >10 reading letters were a percentage higher in the group supplemented with DHA. It is concluded that the combination of intravitreal Ranibizumab with DHA Triglyceride supplementation further reduces central macular thickness after 3 years with significant differences of at least 50 microns in thickness in the central macula, compared to Ranibizumab administered without DHA supplementation. This anatomical improvement is accompanied by a trend toward an improved vision. A significant improvement in Total Antioxidant Capacity, a reduction in the percentage of plasma glycosylated hemoglobin, an increase in membrane DHA, and a reduction in plasma IL-6 levels are also observed.- María Lafuente, et al; Intravitreal Ranibizumab combined with docosahexaenoic acid (DHA) dietetic supplementation in diabetic macular edema: 36 months randomized single-blind controlled trial; Retina 2019; 39: 1083-1090.
- We also wanted to analyze the effects of supplementation using the macular sensitivity analysis technique with macular microperimetry, in a study with 24 patients with non-proliferative diabetic retinopathy, randomized 1:1 to receive or not 1g/day of DHA Triglyceride (BRUDYRETINA 3 capsules/day) for 3 months. We have seen significant differences between both groups in favor of the supplemented group in the improvement of macular sensitivity and in the macular integrity index. It has been also observed an improvement in plasma Total Antioxidant Capacity, an increase in DHA in the erythrocyte membrane, an improvement in the SF-36 vision quality test, and a significant reduction of the expression levels of IL-6 in plasma.-María Elena Rodríguez, et al; Supplementation with a highly concentrated Docosahexaenoic Acid plus xanthophyll carotenoid multivitamin in nonproliferative Diabetic Retinopathy: Prospective controlled Study of macular function by fundus microperimetry; Clinical Ophthalmology 2018; 12: 1011-1020.
- 3- Another recent study has been carried out recruiting 170 patients affected by non-proliferative diabetic retinopathy in early stages of the disease. They were randomized 1:1 to receive supplementation with DHA triglyceride 1g/day (3 caps of BRUDYRETINA) or placebo (olive oil capsules), with a 2-year follow-up. No significant differences were detected between the two groups, but there was a slightly higher percentage of mild stage detection in the group supplemented with DHA (14%) versus the placebo group (11.2%). The moderate degree stage also shows a higher percentage reduction in the group supplemented with DHA (16.4%) versus in the placebo group (10.8%). These differences may indicate a trend towards a greater effect of DHA in slowing progression in the early stages of RDNP.- Rodriguez, et al; Supplementation with a Highly Concentrated Docosahexaenoic
Acid (DHA) in Non-Proliferative Diabetic Retinopathy: A 2-Year Randomized Double-Blind Placebo-Controlled Study; Antioxidants 2022, 11, 116
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Uveitis anterior
DHA TRIGLYCERIDE IN NON-INFECTIOUS ANTERIOR UVEITIS
A study around non-infectious Anterior Uveitis (NIAU) in the remission phase.
- The aim of this study was to evaluate whether DHA triglyceride supplementation in patients with non-infectious anterior uveitis (NIAU) manages to reduce the expression of circulating cytokines in the blood (IL-1, IL-6, IL-2, IL-10, GM-CSF, INF-, TNF- VEGF). For this, 70 subjects have been recruited, of which 35 were patients affected by NIAU in a remission phase, and another 35 were healthy controls. Each of the two groups have been randomized 1:1 to be supplemented with DHA triglyceride, 500mg/day (1 BRUDYITIS capsule) for 3 months, or not supplemented. Variations in the expression of proinflammatory biomarkers in basal and final blood samples have been analyzed by multiplex immunoparticle assay. When comparing the group of patients with NIAU and healthy controls at baseline, the former show significantly higher levels of cytokines and interleukins than the latter. Both in healthy controls and in patients with NIAU who have been supplemented, significantly lower circulating levels of cytokines and interleukins are observed when comparing with the non-supplemented groups. It is shown that DHA triglyceride supplementation is reducing the expression levels of circulating cytokines and interleukins in patients affected by NIAU when comparing the final and basal situation. This results indicate that their dietary intake can be associated with pharmacological anti-inflammatory drugs (NSAIDs, corticosteroids, immunosuppressants, and monoclonal antibodies) which are used in this disease trying to reduce the inflammatory state in this inflammatory eye condition.-MD Pinazo y Manuel Díaz-Llopis; Signature of Circulating Biomarkers in Recurrent Non-Infectious Anterior Uveitis. Immunomodulatory Effects of DHA-Triglyceride. A Pilot Study; Journal of Diagnostics 2021; 11, 724.
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Pigmento macular
DHA TRIGLYCERIDE AND LUTEIN
Effects of co-administration of lutein and DHA triglyceride on the luteinemia and macular pigment optical density.
- The influence of DHA triglyceride supplementation (TG-DHA) in the joint administration with lutein on the optical density of the macular pigment is analyzed. A total of 100 healthy volunteers are randomized 1:1 to receive a supplement containing 6mg/day of lutein plus vitamins and minerals, or another supplement containing 6mg/day of lutein plus vitamins and minerals, but also 700mg/day of DHA-TG, for 90 days. It is shown that the associated supply of lutein with TG-DHA achieves significantly higher levels of lutein in the blood and a significantly higher macular pigment optical density than in the control group supplemented with lutein with no TG-DHA. It is concluded that the contribution of TG-DHA is favorably influencing both the digestive absorption of lutein and its deposit at the level of the macula.-Vicente Zanón-Moreno, et al; Feasibility study of a docosahexaenoic acid optimized nutraceutical formulation on the macular levels of lutein in a healthy Mediterranean population; Ophthalmic Research 2020; 2021;64:1068–1076.
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