A 12-Week-Long Intake of Bilberry Extract (Vaccinium myrtillus L.) Improved Objective Findings of Ciliary Muscle Contraction of the Eye: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparison Trial
Abstract
:1. Introduction
2. Methods and Subjects
2.1. Trial Design and Subjects
- Serious diseases of the digestive system, liver, pancreas, heart, or kidney, or a history of such a disease
- currently under treatment with pharmaceuticals
- ocular diseases other than ametropia (hyperopia, myopia, or astigmatism)
- existing drug and food allergies
- history of, or under treatment for, drug dependence and substance abuse
- nightshift or irregular work hours
- history of refractive surgeries; LASIK (laser-assisted in situ keratomileusis) or others
- users of reading glasses
- current consumption of BE, pharmaceuticals, or supplements that may improve ocular fatigue
- participated in another clinical trial within the last 1 month
- pregnant, breastfeeding, or planning for pregnancy during the trial period
- blood sampling of ≥ 200 mL within the last 1 month, and
- deemed illegible by the trial supervisor or trial attending physician
2.2. Test Foods
2.3. Consumption Methods and Schedule
2.4. Test Items
2.4.1. Ocular Fatigue Test
2.4.2. Safety Evaluation
2.5. Statistical Processing
3. Results
3.1. Subject Background
3.2. Impact on Ocular Fatigue Based on HFC-1 Values
3.3. Safety
4. Discussion
Supplementary Materials
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
Abbreviations
HFC | high-frequency component |
SBE | standardized bilberry extract |
VDT | visual display terminals |
VMA | Vaccinium myrtillus anthocyanin |
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SBE Food | Placebo Food | |
---|---|---|
SBE * | 240.0 | 0 |
Dextrin | 27.2 | 51.0 |
Starch | 45.6 | 193.8 |
Calcium stearate | 22.1 | 22.1 |
Silicon dioxide (fine) | 5.1 | 5.1 |
Caramel color | 0 | 68 |
Examination period | Screening | 0 week | 4 weeks | 8 weeks | 12 weeks |
---|---|---|---|---|---|
Ophthalmic examination (HFC) | ● | ● | ● | ● | ● |
Anthropometric | ● | ● | |||
Doctor’s questions | ● | ● | |||
Blood test/Urinary test | ● | ● | |||
Diary | |
Variables | Placebo | SBE |
---|---|---|
Gender (male/female) (n) | 54 (16/38) | 55 (18/37) |
Age (years) | 35.46 ± 6.96 | 36.18 ± 7.14 |
Height (cm) | 163.72 ± 8.03 | 163.11 ± 8.71 |
Body weight (kg) | 56.78 ± 8.71 | 57.77 ± 10.65 |
Body mass index (kg/m2) | 21.06 ± 2.3 | 21.58 ± 3.13 |
Placebo (n = 48) | SBE (n = 49) | p Value | ||||||
---|---|---|---|---|---|---|---|---|
Mean | ± | SD | Mean | ± | SD | |||
0w | Before VDT load | 50.60 | ± | 4.13 | 51.08 | ± | 3.84 | |
Post VDT load | 50.72 | ± | 4.28 | 52.21 | ± | 4.16 | ||
4w | Before VDT load | 49.51 | ± | 4.13 | 50.90 | ± | 5.04 | |
Post VDT load | 50.81 | ± | 4.92 | 51.37 | ± | 4.29 | 0.225 | |
8w | Before VDT load | 50.94 | ± | 4.93 | 50.08 | ± | 4.68 | |
Post VDT load | 51.13 | ± | 5.19 | 50.64 | ± | 4.70 | * 0.014 | |
12w | Before VDT load | 50.32 | ± | 4.33 | 50.59 | ± | 4.20 | |
Post VDT load | 50.67 | ± | 5.13 | 50.65 | ± | 4.03 | * 0.017 |
Adverse Events | Placebo (n = 54) | SBE (n = 55) |
---|---|---|
Common cold | 12 | 10 |
Headaches | 11 | 18 |
Digestive symptoms (stomachache or diarrhea) | 6 | 6 |
Menstrual pain | 3 | 4 |
Other | 17 | 24 |
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Kosehira, M.; Machida, N.; Kitaichi, N. A 12-Week-Long Intake of Bilberry Extract (Vaccinium myrtillus L.) Improved Objective Findings of Ciliary Muscle Contraction of the Eye: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparison Trial. Nutrients 2020, 12, 600. https://doi.org/10.3390/nu12030600
Kosehira M, Machida N, Kitaichi N. A 12-Week-Long Intake of Bilberry Extract (Vaccinium myrtillus L.) Improved Objective Findings of Ciliary Muscle Contraction of the Eye: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparison Trial. Nutrients. 2020; 12(3):600. https://doi.org/10.3390/nu12030600
Chicago/Turabian StyleKosehira, Marie, Naomichi Machida, and Nobuyoshi Kitaichi. 2020. "A 12-Week-Long Intake of Bilberry Extract (Vaccinium myrtillus L.) Improved Objective Findings of Ciliary Muscle Contraction of the Eye: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparison Trial" Nutrients 12, no. 3: 600. https://doi.org/10.3390/nu12030600