2023 年 10 巻 3 号 p. 110-123
Purpose: A double-blind randomized controlled clinical trial with parallel-group comparison was conducted to confirm the alternations in subjective and objective symptoms, and the safety of ingestion of a test food product (CRISTA®), which contains a high concentration of rooster comb enzymatic degradation product. The primary components are low molecular weight hyaluronic acid (HA) and collagen peptide. Effectiveness on ocular moisturizing effects and safety were assessed. Methods: Thirty healthy subjects who were experienced dry or eye fatigue on a daily basis due to viewing an electronic display for work, were randomly classified into two groups, the test food product group and the control (placebo) group. Among them, excluding one participant (the test food product group), who met exclusion criteria, twenty-nine subjects were subject of analysis for validity verification assessment items: fourteen food product group participants (male: seven, female: seven, age: 38.2 ± 3.2 years) and control food group participants (male: eight, female: seven, age: 38.4 ± 2.7 years). Results: After four-week ingestion of test product, significant increase of lacrimation was confirmed with Schirmer's test. Significant differences were shown in both the test product group and the control group. The effectiveness of the test product was verified to keep the eyes moisturized. There were no differences between two groups regarding Dry Eye Quality of Life (QOL) Questionnaire, Visual Analog Scale for subjective symptoms, Anti-aging QOL Common Questionnaire, tear break-up time, visual acuity, and intra-ocular pressure. The safety of the continuous oral ingestion for as long as four weeks was verified. Conclusion: This test food product is promising as an effective and safe oral ingestion functional food to prevent eye dryness.
