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This study will evaluate the effects of a novel multi-component dietary supplement on the visual function and retinal structure of patients with diabetes with both no diabetic retinopathy and mild to moderate diabetic retinopathy. This is a placebo-controlled trial and neither subjects nor examiners will know if any given subject is taking active supplement or placebo.
The hypothesis is that the supplement will improve visual function and retinal structure in subjects on active supplement
Adult patients with either type 1 or type 2 diabetes will be enrolled with baseline measurement of visual acuity, contrast sensitivity, color vision, threshold macular perimetry, macular pigment optical density, optical coherence tomography, glycosylated hemoglobin, blood lipids and serum vitamin D status. A multi-component dietary supplement containing ingredients currently available over the counter in the US will be taken for six months and repeat measurements of the above parameters obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| supplement - no retinopathy | Experimental | subjects receiving active supplement and with no retinopathy based on clinical examination |
|
| placebo - no retinopathy | Placebo Comparator | patients receiving placebo and who have no diabetic retinopathy based on clinical examination |
|
| supplement - retinopathy | Experimental | patients receiving the active supplement and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination |
|
| placebo - retinopathy | Placebo Comparator | patients receiving placebo and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multi-component nutritional supplement capsules | Dietary Supplement | two capsules containing nutritional supplements per day for 6 months (vitamin C, mixed tocopherols/tocotrienols, vitamin D, fish oil, lutein, zeaxanthin, pine bark extract, benfotiamine, green tea extract, curcumin) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in visual function | Change in contrast sensitivity, color vision and macular perimetry thresholds | At baseline and again at six months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum markers | Changes in glycosylated hemoglobin, serum lipids, serum vitamin D (all subjects) and the serum inflammatory cytokine, tumor necrosis factor-alpha (subjects with retinopathy) | At baseline and again at six months |
| Changes in retinal structure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan P. Chous, O.D. | Chous Eye Care Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chous Eye Care Associates | Tacoma | Washington | 98466 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32990945 | Derived | Robertson NU, Schoonees A, Brand A, Visser J. Pine bark (Pinus spp.) extract for treating chronic disorders. Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD008294. doi: 10.1002/14651858.CD008294.pub5. | |
| 26089210 | Derived | Chous AP, Richer SP, Gerson JD, Kowluru RA. The Diabetes Visual Function Supplement Study (DiVFuSS). Br J Ophthalmol. 2016 Feb;100(2):227-34. doi: 10.1136/bjophthalmol-2014-306534. Epub 2015 Jun 18. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| multi-component dietary supplement | Dietary Supplement | placebo capsules |
|
|
Changes in optical coherence tomography and macular pigment optical density |
| At baseline and again at 6 months |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |