Trial Outcomes & Findings for The Effects of an Antioxidant Formulation on Ocular Blood Flow (NCT NCT01930487)

NCT ID: NCT01930487

Last Updated: 2016-12-05

Results Overview

change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 47 participants
• Primary outcome timeframe: baseline and 30 days
• Results posted on: 2016-12-05

Participant Flow

47 patients were recruited for the study

1 subject started but did not complete the baseline examination and was not randomized to either treatment arm.

Participant milestones

Measure	Supplement With Antioxidants, Then Placebo dietary supplement with antioxidants in the first intervention period, followed by placebo supplement in the second intervention period	Placebo, Then Supplement With Antioxidants placebo supplement in the second intervention period, followed by dietary supplement with antioxidants in the second intervention period
First Intervention (30 Days) STARTED	21	25
First Intervention (30 Days) COMPLETED	19	23
First Intervention (30 Days) NOT COMPLETED	2	2
Washout Period (3 Weeks) STARTED	19	23
Washout Period (3 Weeks) COMPLETED	19	23
Washout Period (3 Weeks) NOT COMPLETED	0	0
Second Intervention (30 Days) STARTED	19	23
Second Intervention (30 Days) COMPLETED	19	23
Second Intervention (30 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of an Antioxidant Formulation on Ocular Blood Flow

Baseline characteristics by cohort

Measure	Participants Completing Study n=42 Participants Participants who completed both arms of the crossover study
Age, Continuous	67 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants
Diabetes (Type 2) yes	21 participants n=5 Participants
Diabetes (Type 2) no	21 participants n=5 Participants
Hypertension yes	16 participants n=5 Participants
Hypertension no	26 participants n=5 Participants
Study Eye right	24 participants n=5 Participants
Study Eye left	18 participants n=5 Participants
Duration of OAG	15 years STANDARD_DEVIATION 8 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)

Outcome measures

Measure	Dietary Supplement With Antioxidants n=42 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=42 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Superior Retinal Capillary Blood Flow (% Zero Pixels)	-0.026 % zero pixels Standard Error 0.008	0.011 % zero pixels Standard Error 0.007

PRIMARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)

Outcome measures

Measure	Dietary Supplement With Antioxidants n=42 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=42 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels)	-0.016 % zero pixels Standard Error 0.007	0.009 % zero pixels Standard Error 0.007

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in ocular perfusion pressure (2/3 Mean arterial pressure - intraocular pressure)

Outcome measures

Measure	Dietary Supplement With Antioxidants n=42 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=42 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Ocular Perfusion Pressure	1.5 mm Hg Standard Error 0.9	1.4 mm Hg Standard Error 1.2

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

Outcome measures

Measure	Dietary Supplement With Antioxidants n=42 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=42 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s)	0.74 cm/s Standard Error 0.41	-0.94 cm/s Standard Error 0.38

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

Outcome measures

Measure	Dietary Supplement With Antioxidants n=42 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=42 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s)	0.54 cm/s Standard Error 0.15	-0.43 cm/s Standard Error 0.15

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

Outcome measures

Measure	Dietary Supplement With Antioxidants n=42 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=42 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)	0.30 cm/s Standard Error 0.14	-0.16 cm/s Standard Error 0.16

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

Outcome measures

Measure	Dietary Supplement With Antioxidants n=42 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=42 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)	0.31 cm/s Standard Error 0.16	-0.14 cm/s Standard Error 0.15

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

Outcome measures

Measure	Dietary Supplement With Antioxidants n=42 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=42 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s)	0.35 cm/s Standard Error 0.13	-0.17 cm/s Standard Error 0.17

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

Outcome measures

Measure	Dietary Supplement With Antioxidants n=42 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=42 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s)	0.27 cm/s Standard Error 0.05	-0.11 cm/s Standard Error 0.06

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

Outcome measures

Measure	Dietary Supplement With Antioxidants n=42 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=42 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)	0.17 cm/s Standard Error 0.05	-0.07 cm/s Standard Error 0.05

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

Outcome measures

Measure	Dietary Supplement With Antioxidants n=42 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=42 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)	0.15 cm/s Standard Error 0.05	-0.06 cm/s Standard Error 0.05

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)

Outcome measures

Measure	Dietary Supplement With Antioxidants n=42 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=42 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio)	-0.007 ratio Standard Error 0.004	-0.005 ratio Standard Error 0.006

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)

Outcome measures

Measure	Dietary Supplement With Antioxidants n=42 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=42 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio)	-0.018 ratio Standard Error 0.006	0.000 ratio Standard Error 0.006

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in nasal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)

Outcome measures

Measure	Dietary Supplement With Antioxidants n=42 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=42 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Nasal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)	-0.013 ratio Standard Error 0.006	0.005 ratio Standard Error 0.005

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in temporal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)

Outcome measures

Measure	Dietary Supplement With Antioxidants n=42 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=42 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)	-0.009 ratio Standard Error 0.006	0.004 ratio Standard Error 0.005

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM	1.71 cm/s Standard Error 0.56	-0.84 cm/s Standard Error 0.48

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM	-0.24 cm/s Standard Error 0.53	-1.03 cm/s Standard Error 0.60

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM	0.58 cm/s Standard Error 0.20	-0.44 cm/s Standard Error 0.24

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM	0.51 cm/s Standard Error 0.23	-0.41 cm/s Standard Error 0.20

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM	0.56 cm/s Standard Error 0.22	-0.46 cm/s Standard Error 0.23

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM	0.03 cm/s Standard Error 0.16	0.13 cm/s Standard Error 0.22

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM	0.24 cm/s Standard Error 0.19	-0.32 cm/s Standard Error 0.21

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM	0.38 cm/s Standard Error 0.27	0.03 cm/s Standard Error 0.21

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM	0.60 cm/s Standard Error 0.19	-0.18 cm/s Standard Error 0.24

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM	0.09 cm/s Standard Error 0.18	-0.16 cm/s Standard Error 0.24

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - DM	0.29 cm/s Standard Error 0.06	-0.08 cm/s Standard Error 0.11

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM	0.26 cm/s Standard Error 0.07	-0.14 cm/s Standard Error 0.07

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM	0.16 cm/s Standard Error 0.07	-0.16 cm/s Standard Error 0.08

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM	0.18 cm/s Standard Error 0.07	0.01 cm/s Standard Error 0.07

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM	0.10 cm/s Standard Error 0.07	-0.13 cm/s Standard Error 0.07

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM	0.20 cm/s Standard Error 0.08	0.01 cm/s Standard Error 0.08

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM	-0.008 ratio Standard Error 0.007	-0.005 ratio Standard Error 0.009

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - No DM	-0.005 ratio Standard Error 0.006	-0.004 ratio Standard Error 0.009

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM	-0.019 ratio Standard Error 0.010	-0.004 ratio Standard Error 0.011

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - No DM	-0.017 ratio Standard Error 0.007	0.004 ratio Standard Error 0.007

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in nasal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM	-0.005 ratio Standard Error 0.007	0.005 ratio Standard Error 0.007

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in nasal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM	-0.022 ratio Standard Error 0.010	0.005 ratio Standard Error 0.007

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in temporal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM	-0.006 ratio Standard Error 0.009	0.010 ratio Standard Error 0.007

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in temporal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM	-0.012 ratio Standard Error 0.009	-0.001 ratio Standard Error 0.007

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients with type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Ocular Perfusion Pressure - DM	0.2 mm Hg Standard Error 1.2	-1.1 mm Hg Standard Error 1.4

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients without type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Ocular Perfusion Pressure - No DM	2.8 mm Hg Standard Error 1.4	3.8 mm Hg Standard Error 1.7

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients with type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - DM	-0.031 % zero pixels Standard Error 0.009	0.012 % zero pixels Standard Error 0.010

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients without type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - No DM	-0.021 % zero pixels Standard Error 0.014	0.010 % zero pixels Standard Error 0.009

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients with type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - DM	-0.005 % zero pixels Standard Error 0.009	0.000 % zero pixels Standard Error 0.008

SECONDARY outcome

Timeframe: baseline and 30 days

Population: patients completing both study periods

change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients without type 2 diabetes

Outcome measures

Measure	Dietary Supplement With Antioxidants n=21 Participants Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids	Placebo n=21 Participants Placebo identical in appearance to active Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - No DM	-0.028 % zero pixels Standard Error 0.009	0.018 % zero pixels Standard Error 0.010

Adverse Events

Supplement w/ Antioxidants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brent Siesky, PhD, Assistant Director

Ocular Vascular Research Center, Indiana University School of Medicine

Phone: 317-278-0177

Email: bsiesky@indiana.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place