50 subjects with center-involved diabetic macular edema (CI-DME) and scheduled for treatment with intravitreal injection of anti-VEGF agents will receive softgel placebo containing canola oil, 2 capsules per day during the study duration

50 subjects receiving two DiVFuSS softgels per day

50 subjects receiving 4 DiVFuss softgels per day

Center-involved Diabetic Macular Edema (CI-DME)

The adjunctive nutritional supplement will be the multi-component formula used in the Diabetes Visual Function Supplement Study (Western IRB number 1129944 Olympia, WA), containing the macular carotenoids lutein and zeaxanthin, as well as antioxidants (vitamins B1, B12, C, D, E, lipoic acid, coenzyme Q10, resveratrol), omega3 fatty acids (EPA/DHA) and botanical extracts (Pycnogenol™ [patented extract of French maritime pine bark, Pinus pinaster], grape seed and green tea extracts, curcumin).

Diabetes Visual Function Study (DiVFuSS) softgels

Placebo containing canola oil, 2 softgels per day

canola oil placebo softgels, 2 per day

Sound Retina

Prospective Study of Adjunctive Carotenoids Plus Anti-oxidants in Anti-VEGF Treated Diabetic Macular Edema

Best-corrected visual acuity at entry and conclusion of study

Change in macular subfield thicknesses from baseline to study conclusion

The number of intravitreal anti-VEGDF injections required for treatment of center-involved diabetic macular edema

The number of subjects in each arm requiring adjunctive laser photocoagulation or intravitreal steroids for treatment of CI-DME

ZeaVision, LLC

This will be an investigator initiated, single-clinic/two location, double-blinded prospective study of 150 adult subjects with newly diagnosed CI-DME receiving anti-VEGF injections, with add-on laser and/or steroid as required on follow-up examination (Standard Treatment) versus standard treatment plus adjunctive DiVFuSS supplementation in one of two doses (2 softgels per day - Supplement Treatment Group 1; and 4 softgels per day - Supplement Treatment Group 2). Subjects will be identified and enrolled with informed consent from two retinal specialty practice sites in Washington State (Sound Retina; Tacoma, WA and Olympia, WA). Subjects will be randomized to Standard Treatment; Supplement Treatment Group 1, or Supplement Treatment Group 2.

After enrollment by the study Primary Investigator, a single retinal specialist from each site, masked to subjects' supplement status, will deliver all treatments per his/her usual protocol for treatment of CI-DME based on individual examination findings. Supplements and identically-appearing placebo will be provided by ZeaVision, LLC of Chesterfield, MO.

Intervention group will receive French maritime pine bark extract supplement (OLIGOPIN) in the form oral capsules containing 50 mg French maritime pine bark extract plus 130 mg Microcrystalline Cellulose. OLIGOPIN powder of each capsule are dissolved in 10 ml deionized water and given to patients via gavage (3 capsule per day) for 10 days

Control group will receive oral capsules containing 130 mg Microcrystalline Cellulose with 10 ml of deionized water via gavage (3 capsule per day) for 10 days.

Traumatic Brain Injury

investigators obtained ethical approval from the Research Ethics Committees of the Mashhad University of medical sciences. investigators enroll 60 patients who are admitted to ICU at hospitals of university. All eligible patients or their first degree relatives give informed consent before participating. Participants are randomly (block stratification) divided in two groups. At the first visit, baseline data are gathered and intervention group (n=30) will receive Oligopin supplement. In order to control the confounding effect of food intake, both the control and the intervention group receive the standard formulas based on their daily required energy via enteral root feeding.

Dietary Supplement (OLIGOPIN)

investigators obtained ethical approval from the Research Ethics Committees of the Mashhad University of medical sciences. investigators enroll 60 patients who are admitted to ICU at hospitals of university. All eligible patients or their first degree relatives give informed consent before participating. Participants are randomly (block stratification) divided in two groups. At the first visit, baseline data are gathered and control group (n=30) will receive oral capsules containing 130 mg Microcrystalline Cellulose. In order to control the confounding effect of food intake, both the control and the intervention group receive the standard formulas based on their daily required energy via enteral root feeding.

Placebo

Mahsa Malekahmadi

Evaluation the Effects of French Maritime Pine Bark Extract on the Clinical Status in Traumatic Brain Injury Patients

Evaluation the Effects of French Maritime Pine Bark Extract Supplementation on the Inflammatory Biomarkers, Nutritional and Clinical Status in Traumatic Brain Injury Patients, in Intensive Care Unit; A Randomized Clinical Trial

measurement is done via Bio impedance device "Inbody"

The Acute Physiology and Chronic Health Evaluation (APACHE II) is a severity score and mortality estimation tool developed from a large sample of ICU patients in the United States.
Interpretation: Score: 0-4: Death Rate (%):4, Score: 5-9:Death Rate (%):8, Score: 10-14:Death Rate (%):15, Score: 15-19:Death Rate (%):25, Score: 20-24:Death Rate (%):40, Score: 25-29:Death Rate (%):55, Score: 30-34:Death Rate (%):75. Score: ˃ 34 :Death Rate (%):85.

The Sequential Organ Failure Assessment (SOFA) is a morbidity severity score and mortality estimation tool developed from a large sample of ICU patients throughout the world. The SOFA was designed to focus on organ dysfunction and morbidity, with less of an emphasis on mortality prediction.
Interpretation: Score: 0-6: Death Rate (%):< 10%, Score: 7-9:Death Rate (%):15 - 20%, Score: 10-12:Death Rate (%):40 - 50%, Score: 13-14:Death Rate (%):50 - 60%, Score: 15:Death Rate (%):> 80%, Score: 15-24:Death Rate (%):> 90%.

The NUTRIC score (Nutrition assessment in critically ill) is a rapid assessment of nutritional state based on illness severity, age and co-morbidities.
Sum of points: 6-10: CATEGORY: High Score. Sum of points: 0-5: CATEGORY: LOW Score High score associated with worse clinical outcomes (mortality, ventilation).These patients are the most likely to benefit from the aggressive nutrition therapy.
LOW Score: These patients have a low malnutrition risk

principal investigator

Mashhad University of Medical Sciences

On enrolment, study nutritionist or clinicians take a consecutive sealed opaque envelope containing the unique patient identifier but not the study group, to which they remain masked. A paired set of sealed envelopes are kept in a locked cabinet in the study laboratory, label with the unique patient identifier and containing the study group allocation. These are opened by the nutritionist. Investigators, all study staff hospital attending clinical teams, and patients were masked to the study group allocation.

pinus pinaster/antioksidant

Prospective Study of Adjunctive Carotenoids Plus Anti-oxidants in Anti-VEGF Treated Diabetic Macular Edema

Evaluation the Effects of French Maritime Pine Bark Extract on the Clinical Status in Traumatic Brain Injury Patients

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