Diabetes Visual Function Supplement Study

Effects of a Novel Dietary Supplement on Visual Function in Patients With Diabetes With and Without Early Diabetic Retinopathy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01646047

Acronym

DiVFuSS

Enrollment

Registered

2012-07-20

Start date

2012-05-31

Completion date

2014-09-30

Last updated

2015-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2, Non-proliferative Diabetic Retinopathy

Keywords

diabetes, diabetic retinopathy, nutritional supplements, visual function, macular pigment, macular threshold sensitivity, contrast sensitivity, color vision, optical coherence tomography

Brief summary

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

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTmulti-component nutritional supplement capsules

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)

DIETARY_SUPPLEMENTmulti-component dietary supplement

placebo capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* diabetes mellitus diagnosed at least 5 years * age greater than or equal to 18 years * English speaker

Exclusion criteria

* proliferative diabetic retinopathy or severe non-proliferative retinopathy * clinically significant macular edema * corrected visual acuity less than 20/30 in either eye * diagnosis of other serious eye disease (glaucoma, age-related maculopathy) * less than 18 years old * non-English speaker * no known allergy or sensitivity to any supplement ingredients

Design outcomes

Primary

Measure	Time frame	Description
Changes in visual function	At baseline and again at six months	Change in contrast sensitivity, color vision and macular perimetry thresholds

Secondary

Measure	Time frame	Description
Changes in serum markers	At baseline and again at six months	Changes in glycosylated hemoglobin, serum lipids, serum vitamin D (all subjects) and the serum inflammatory cytokine, tumor necrosis factor-alpha (subjects with retinopathy)
Changes in retinal structure	At baseline and again at 6 months	Changes in optical coherence tomography and macular pigment optical density

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026