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The goal of the clinical study is to evaluate the impact of daily use of a dietary supplement TF Vista containing AREDS2 formula ingredients, astaxanthin (Haematococcus pluvialis) microalgae, bilberry (Vaccinium myrtillus) fruit powder and black currant (Ribes nigrum) fruit powder organic on skin carotenoid levels over an 8-week period for a Cohort 1(n= 20 participants) and 12 weeks for a Cohort 2 (n= 4 participants). Results will be compared using two devices - the Veggie Meter and the Samsung Watch - both of which utilize reflection spectroscopy technology. For Cohort 2 (n = 4 participants), in addition to assessing skin carotenoid levels, the study will also evaluate changes in macular pigment optical density (MPOD) before and after supplementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4lLife TF Vista | Experimental | Participants were supplied with two bottles of the study product (for Cohort-1) and three bottles (for Cohort-2) labeled with the participant number during the study. They were required to take the product consisting of 4 capsules per day, taken with 8 oz. of fluid and preferably with a meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplement | Other | Study product 4Life TF Vista contains Tri Factor (bovine colostrum and egg yolk), bilberry (Vaccinium myrtillus) fruit powder, black currant (Ribes Nigrum) powder, lutein, zeaxanthin (Tagetes erecta), vitamin C, vitamin A, vitamin E, zinc, and copper. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Carotenoid Levels | Skin carotenoid levels measured via a portable Veggie Meter, Longevity Link Corp. device using reflection spectroscopy on a participant's fingerprint. | From enrollment to the end of treatment at 8 weeks for Cohort-1 and 12 weeks for Cohort-2 |
| Measure | Description | Time Frame |
|---|---|---|
| Antioxidant Levels | Antioxidant levels assessed by a Samsung Watch device via skin absorption spectra. The bioactive sensor measures reflected light after emitting LED light. The test requires the participant to press the thumb on the sensor for a few seconds to get a reading. | From enrollment to the end of treatment at 8 weeks for Cohort-1 and 12 weeks for Cohort-2. |
| Measure | Description | Time Frame |
|---|---|---|
| Macular Pigment Optical Density (MPOD) | Macular Pigment Optical Density (MPOD) testing measurement of the density of the light-absorbing pigments in the center of the retina. This tests is performed only for participants in Cohort-2. | At enrollment and at the end of the treatment (week-12) |
| Visual Acuity Test |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Vollmer | 4Life Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 4Life Research | Sandy City | Utah | 84070 | United States |
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Visual Acuity Test to measure sharpest vision using a Snellen eye chart, to determine the smallest detail a participant can see from 20 feet distance. Test will be performed only for participants included in Cohort-1 |
| From enrollment to the end of treatment at 8 weeks. |
| Amsler Grid Chart Test | Amsler Grid Chart Test to monitor central vision for changes like way, blurry, or missing lines. Test performed only on participants included in Cohort-1. | From enrollment to the end of treatment at 8 weeks. |
| Visual Functioning Questionnaire-25 (VFQ-25) | Visual Functioning Questionnaire-25 (VFQ-25) to assess participants self-reported vision- related quality of life. For participants included in Cohort-1. | From enrollment to the end of treatment at 8 weeks. |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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