Clinical Effects of Dietary Supplementation of Lutein with High Bio-Accessibility on Macular Pigment Optical Density and Contrast Sensitivity: A Randomized Double-Blind Placebo-Controlled Parallel-Group Comparison Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Target Population
- Individuals who were currently receiving some form of drug treatment or outpatient treatment;
- Individuals who were currently undergoing exercise or diet therapy under the supervision of a physician;
- Individuals who have a prior history of, are currently experiencing, or present with concomitant hepatic or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic diseases;
- Individuals who have a prior history of chronic diseases, such as arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, and other chronic diseases or who were being treated for these diseases;
- Individuals who have a prior history of gastrointestinal surgery (appendicitis allowed);
- Individuals who have eye diseases other than a refractive error (hyperopia, myopia, and astigmatism);
- Individuals who have a prior history of drug or food allergies;
- Pregnant or breastfeeding women and women wishing to become pregnant or breastfeed during the study;
- Individuals who have received blood transfusions or immunizations within the past 3 months or who plan to receive them during the study period;
- Individuals who consume health foods, supplements, and pharmaceutical products that may affect visual function on a regular basis;
- Individuals who have been or are currently being regularly monitored as outpatients at a psychiatric department for psychiatric (e.g., depression) or sleep disorders;
- Individuals who have a prior history of or are currently being treated for alcohol dependence, drug dependence, or substance abuse;
- Shift workers such as those who work night shifts;
- Individuals with extremely irregular lifestyles, such as those with irregular eating and sleeping patterns;
- Current smokers;
- Individuals who are currently participating or have participated in other clinical trials within 3 months prior to the date of providing informed consent;
- Individuals who have difficulties in adhering to entering records for each questionnaire;
- Other individuals considered inappropriate for inclusion in the trial by the principal investigator.
2.2. Study Diet
2.3. Administration Method and Schedule
2.4. Test Parameters
2.4.1. Serum Lutein Levels
2.4.2. Macular Pigment Optical Density Test
2.4.3. Contrast and Glare Sensitivity Tests
2.4.4. Safety Evaluation
2.5. Statistical Analysis
3. Results
3.1. Subject Characteristics
3.2. Serum Lutein Levels
3.3. MPOD
3.4. Contrast Sensitivity and Glare Sensitivity
3.5. Safety
4. Discussion
5. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Components | Placebo Capsule | Lutein Capsule |
---|---|---|
Marigold dye preparation (lutein-free form) | 0 mg | 30 mg (6 mg) |
Vegetable oil | 180 mg | 150 mg |
Variables | Placebo Group | Lutein Group |
---|---|---|
Sex (male/female) (n) | 31 (10/21) | 28 (9/19) |
Age (years) | 41.10 ± 12.77 | 42.61±14.62 |
Height (cm) | 164.26 ± 8.15 | 162.23±8.35 |
Body weight (kg) | 58.00 ± 10.01 | 55.10±7.00 |
Body mass index (kg/m2) | 21.34 ± 2.05 | 20.90±1.87 |
Test Parameter | Group | Week 0 | Week 8 | Week 16 |
---|---|---|---|---|
Serum lutein concentration (µmol/L) | Placebo (n = 31) | 0.381 ± 0.194 | 0.407 ± 0.187 | 0.391 ± 0.175 |
Lutein (n = 28) | 0.417 ± 0.193 | 0.836 ± 0.446 *** | 0.751 ± 0.473 *** | |
MPOD | Placebo (n = 62) | 0.522 ± 0.145 | 0.521 ± 0.148 | 0.523 ± 0.159 |
Lutein (n = 54) | 0.498 ± 0.185 | 0.521 ± 0.180 | 0.545 ± 0.173 † |
0 w | 8 w | 16 w | ||||
---|---|---|---|---|---|---|
Placebo Group (n = 62) | Lutein Group (n = 54) | Placebo Group (n = 62) | Lutein Group (n = 54) | Placebo Group (n = 62) | Lutein Group (n = 54) | |
Contrast sensitivity | ||||||
6.3° (log) | 1.914 ± 0.176 | 1.910 ± 0.161 | 1.893 ± 0.177 | 1.890 ± 0.190 | 1.908 ± 0.172 | 1.987 ± 0.062 ** |
4.0° (log) | 1.820 ± 0.235 | 1.825 ± 0.217 | 1.781 ± 0.212 | 1.808 ± 0.198 | 1.839 ± 0.237 | 1.913 ± 0.155 * |
2.5° (log) | 1.619 ± 0.308 | 1.650 ± 0.264 | 1.596 ± 0.255 | 1.645 ± 0.268 | 1.630 ± 0.320 | 1.671 ± 0.226 |
1.6° (log) | 1.259 ± 0.350 | 1.299 ± 0.290 | 1.292 ± 0.327 | 1.293 ± 0.267 | 1.291 ± 0.354 | 1.335 ± 0.267 |
1.0° (log) | 0.985 ± 0.336 | 1.016 ± 0.287 | 1.009 ± 0.300 | 0.986 ± 0.274 | 0.999 ± 0.368 | 1.033 ± 0.259 |
0.64° (log) | 0.676 ± 0.330 | 0.703 ± 0.282 | 0.702 ± 0.332 | 0.684 ± 0.327 | 0.698 ± 0.344 | 0.703 ± 0.270 |
Glare Sensitivity | ||||||
6.3° (log) | 1.521 ± 0.286 | 1.579 ± 0.202 | 1.540 ± 0.251 | 1.523 ± 0.243 | 1.523 ± 0.292 | 1.585 ± 0.192 |
4.0° (log) | 1.489 ± 0.288 | 1.560 ± 0.228 | 1.504 ± 0.256 | 1.524 ± 0.247 | 1.453 ± 0.299 | 1.571 ± 0.202 * |
2.5° (log) | 1.356 ± 0.306 | 1.428 ± 0.208 | 1.363 ± 0.255 | 1.398 ± 0.240 | 1.339 ± 0.322 | 1.460 ± 0.220 * |
1.6° (log) | 1.113 ± 0.367 | 1.177 ± 0.261 | 1.141 ± 0.328 | 1.154 ± 0.267 | 1.091 ± 0.369 | 1.146 ± 0.246 |
1.0° (log) | 0.808 ± 0.377 | 0.824 ± 0.278 | 0.825 ± 0.384 | 0.805 ± 0.322 | 0.788 ± 0.419 | 0.810 ± 0.272 |
0.64° (log) | 0.561 ± 0.336 | 0.569 ± 0.263 | 0.563 ± 0.332 | 0.524 ± 0.303 | 0.510 ± 0.371 | 0.536 ± 0.261 |
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Machida, N.; Kosehira, M.; Kitaichi, N. Clinical Effects of Dietary Supplementation of Lutein with High Bio-Accessibility on Macular Pigment Optical Density and Contrast Sensitivity: A Randomized Double-Blind Placebo-Controlled Parallel-Group Comparison Trial. Nutrients 2020, 12, 2966. https://doi.org/10.3390/nu12102966
Machida N, Kosehira M, Kitaichi N. Clinical Effects of Dietary Supplementation of Lutein with High Bio-Accessibility on Macular Pigment Optical Density and Contrast Sensitivity: A Randomized Double-Blind Placebo-Controlled Parallel-Group Comparison Trial. Nutrients. 2020; 12(10):2966. https://doi.org/10.3390/nu12102966
Chicago/Turabian StyleMachida, Naomichi, Marie Kosehira, and Nobuyoshi Kitaichi. 2020. "Clinical Effects of Dietary Supplementation of Lutein with High Bio-Accessibility on Macular Pigment Optical Density and Contrast Sensitivity: A Randomized Double-Blind Placebo-Controlled Parallel-Group Comparison Trial" Nutrients 12, no. 10: 2966. https://doi.org/10.3390/nu12102966
APA StyleMachida, N., Kosehira, M., & Kitaichi, N. (2020). Clinical Effects of Dietary Supplementation of Lutein with High Bio-Accessibility on Macular Pigment Optical Density and Contrast Sensitivity: A Randomized Double-Blind Placebo-Controlled Parallel-Group Comparison Trial. Nutrients, 12(10), 2966. https://doi.org/10.3390/nu12102966