This study aims to investigate the effects of MaquiBright ® , also known as BrightSight ® , a standardized maqui berry extract, on improving eye dryness and fatigue in Japanese subjects (aged 30–60 years) experiencing eye dryness, eye fatigue, and ≥4 h of visual display terminal (VDT) work daily. Seventy-four participants were equally but randomly assigned to either a MaquiBright ® (MB) or a placebo (P) group, wherein each participant consumed one capsule daily for 4 weeks of the appropriate treatment (MaquiBright ® 60 or 0 mg). Eye dryness and fatigue were measured using the Schirmer's test, tear break-up time (BUT) test, pupillary response, and flicker test before intake and 4 weeks after intake. Furthermore, subjective symptoms were assessed using the Visual Analogue Scale (VAS) method and the Dry Eye–related Quality of Life Score (DEQS) questionnaire. The MB group demonstrated a significantly higher lacrimal fluid production in both eyes (increased 6.4 ± 8.1 mm, P = 0.005) in Schirmer's test compared to the P group before VDT load (playing a video game) at 4 weeks after intake. In the VAS method after VDT load, the reduction of subjective symptoms in eye fatigue ( P = 0.047) and stiff shoulders ( P = 0.035) were significantly higher in the MB group than in the P group as well as bothersome ocular symptoms ( P = 0.037) by the DEQS. No adverse events were reported. Thus, the consumption of 60 mg of MaquiBright ® per day for 4 weeks reduced eye dryness and seemed to alleviate eye fatigue.

Background and objective: The ingestion of plant-derived glucosylceramides (GlcCer) has been reported to contribute to skin barrier function and hydration of the epidermis. b-sitosterol glucoside (BSG) colocalized with GlcCer in the rice hydrophobic fraction has been shown to increase ceramides in the stratum corneum in vitro. Although clinical studies demonstrated that GlcCer reduced transepidermal water loss (TEWL), the contribution of BSG to epidermal dehydration when applied with GlcCer remains unknown. Therefore, we herein conducted a clinical trial on the effects of a rice-derived mixed fraction of GlcCer and BSG (Oryza Ceramide®) on TEWL and other skin parameters. Methods: A randomized, double-blind, placebo-controlled study design was used. Oryza Ceramide® (type PCD, 40 mg daily) containing 1.2 mg of GlcCer and 40 mg of BSG was used as the active sample. We enrolled 44 healthy Japanese women with epidermal dehydration. All subjects were randomly allocated to an active group (n=22) or placebo group (n=22) using a computerized random number generator. Capsules containing the active sample or placebo were administered for 12 weeks between August and December 2020. Cheek TEWL after 12 weeks was assessed as the primary outcome, and TEWL on a different part of the skin and various skin parameters, including epidermal moisture, pigmentation, pores, and elasticity, were measured before and after 4, 8, and 12 weeks of the intervention. Blood, urine, and body parameters were also examined to evaluate safety.Results: Forty-four subjects completed the trial, and the per protocol set comprised 22 each in the active and placebo groups. Cheek TEWL significantly reduced after the Oryza Ceramide® intervention for 4 and 12 weeks. Among the secondary outcomes examined, lip moisture (12 weeks) and visible pore number (4 weeks) were improved by Oryza Ceramide®. Laboratory tests revealed no abnormalities to suggest any adverse effects of Oryza Ceramide®.Conclusions: Oryza Ceramide® (40 mg/day) consisting of GlcCer and BSG improved facial TEWL, lip moisture, and visible pores, and these effects may be attributed to increases in epidermal ceramides. The combination of rice GlcCer and BSG appears to be beneficial for improving facial skin conditions.Trial Registration: UMIN-CTR: UMIN000041295Foundation: The study was funded by Oryza Oil & Fat Chemical Co., Ltd. and Aichi Prefectural Subsidies for Research and Development of Creative Products in 2020.Keywords: rice; glucosylceramide; β-sitosterol glucoside; trans epidermal water loss; pore

This study investigated the effects of proanthocyanidins derived from Acacia (Acacia mearnsii) bark extract in healthy Japanese adult subjects experiencing uncomfortable skin symptoms. All subjects were randomly allocated into two groups (n = 33 each) using a computerized random-number generator. The subjects received either Acacia bark extract tablets or placebo for 8 weeks. Evaluations included water content in the stratum corneum, transepidermal water loss (TEWL), Skindex-16, dermatology life quality index (DLQI), visual analog scale for desire to scratch, and blood tests. At 4 weeks, the symptom/feeling score of DLQI, subjective symptoms related to uncomfortable skin, and the desire to scratch were significantly reduced in the intervention group than in the placebo group. At 8 weeks, the intervention group exhibited significantly lower TEWL on facial skin than that in the placebo group. In conclusion, the intake of Acacia bark extract tablets reduced TEWL and improved dry and uncomfortable skin.

Background and Objective: Tomato seeds are edible seeds unconsciously ingested with the fruit. However, there are few reports regarding the constituents and biological activities of tomato seed extract (TSE). Recently, we found that saponins are major constituents of TSE including lycoperoside H. Previous reports have described that several plant-derived saponins improve skin diseases such as wounds and microangiopathy. Therefore, to discover the effect of TSE on the skin condition, we conducted a clinical trial of TSE (Tomato Seed Extract-P) standardized with lycoperoside H when orally ingested. Methods: The study was performed as a randomized, double-blind, placebo-controlled study. TSE (200 mg daily) containing 1 mg of lycoperoside H was used as the active sample. We enrolled 44 Japanese women who have concerns about facial elasticity and relatively low facial skin elasticity. All subjects were randomly allocated into either the active group (n = 22) or the placebo group (n = 22) using a computerized random-number generator. Capsules containing either the active sample or a placebo were administered for 8 weeks between October 12, 2020, and January 16, 2021. Facial elasticity, specifically the R7 value, was evaluated as the primary outcome. The remaining facial R parameters, upper arm R parameters, and other skin parameters including epidermal moisture, trans epidermal water loss, dermal parameters, and advanced glycation end products (AGEs) parameters were measured at 0, 4, and 8 weeks of ingestion. Blood, urine, and body parameters were also evaluated for safety. Results: Forty-three subjects completed the trial,

Background and objective: The fruit of Mauritia flexuosa (moriche palm), which is known as “Aguaje,” has been used for beverages and processed foods. Recently, we found that several methoxyflavans are contained in the fruit and they exhibit estrogenic activities. Therefore, moriche palm extract (MPE) may function as a phytoestrogen and improve the symptoms induced by estrogen deficiency. However, the clinical effects of MPE on females has not yet been reported. We conducted a clinical trial of MPE on undefined complaints related to premenstrual syndrome (PMS) in healthy Japanese females.Methods: This randomized, double-blind, placebo-controlled study examined the effects of MPE (100 mg daily) containing 12.6  g of 5,4'-dihydroxy-7-methoxy-6-methylflavan. Forty-four Japanese women with indefinite complaints in premenstrual and menstrual periods were enrolled in the study. All subjects were randomly allocated into either the MPE (100 mg) group (n=22) or the placebo group (n=22) using a computerized random-number generator. Capsules containing either MPE (100 mg) or placebo were administered for 8 weeks between October and December in 2018. The severity of uncertain complaints and emotional status were evaluated using the Japanese version of the menstrual distress questionnaire (MDQ) as a primary outcome, and Medical Outcomes Study Short-Form 36-Item Health (SF-36) questionnaire at 4 and 8 weeks of ingestion. Blood, urine, and body parameters were also evaluated.Results: Forty-three subjects completed the trial, and the per protocol set comprised 21 subjects in the MPE (100 mg) group and 22 subjects in the placebo group. After ingesting MPE for 4 weeks, arousal in the premenstrual period significantly improved in the MPE (100 mg) group. After 8 weeks, the summary score, water retention, impaired concentration and control during menstrual period significantly improved in the MPE (100 mg) group. Contrarily, among SF-36 domain scores, significant ameliorating effects of MPE were not observed compared with those of the placebo group. Laboratory tests revealed no abnormalities suggesting adverse effects of MPE.Conclusions: MPE (100 mg/day for 8 weeks) improved several indefinite complaint parameters related to mensuration. MPE was suggested to be useful for improving anxiety related to PMS.Keywords: Menstrual distress questionnaire; SF-36 questionnaire; moriche palm; methoxyflavan; indefinite complaint

Background: Some natural substances may affect the expression of microRNAs (miRNAs) in humans. However, it is unclear whether this effect can be induced by the ingestion of whole foods containing these natural substances. Objective: We investigated whether ingestion of the whole food FFC ® Pairogen affects the expression of miRNAs in humans. Design: This was a pilot study and part of a randomized controlled trial. Four subjects ingested the test material daily for 8 weeks (three times 180 ml bottles a day, morning, noon and evening; a total of 540 ml per day). The study did not include control subjects. Results: Several miRNAs showed differential expression. The expression of two miRNAs, hsa-let-7c and hsa-miR-92a-2-5p, changed in three of the four subjects, who had lower concentration of serum total antioxidant status. The expression of hsa-let-7c increased and that of hsa-miR-92a-2-5p decreased. Conclusions: The expression of hsa-let-7c and hsa-miR-92a-2-5p has been linked with lung cancer manifestation. The increased expression of hsa-let-7c and the decreased expression of hsa-miR-92a-2-5p suggest possible oncogene suppressive functions of these miRNAs. The ingestion of FFC ® Pairogen may have a positive effect on cancer prevention.

Background and objective: Chrysanthemum flowers are consumed as fresh condiments, herbal teas, and processed foods in Japan and Taiwan. They contain luteolin as a major polyphenol and are traditionally used for eye care. We previously demonstrated that the ingestion of Chrysanthemum flower extract (CFE) for 1 month reduced serum uric acid levels. However, the findings obtained were considered to be biased because the study was performed by a CFE manufacturer. Therefore, we herein conducted a clinical trial on CFE on a larger scale and examined its effects on purine base absorption from the intestines, which represents an effective approach for reducing serum uric acid levels. Methods: Both studies were performed as randomized, double-blind, placebo-controlled trials and CFE (100 mg) containing 1 mg of luteolin was used as the active sample. We enrolled 44 healthy Japanese men and women with 6.0 to 7.9 mg/dL serum uric acid. All subjects were randomly allocated to an active group (n=22) or placebo group (n=22) using a computerized random number generator. In the purine base absorption study, CFE was ingested with a purine base-rich diet and serum uric acid levels were measured chronologically. In the 12-week consecutive ingestion study, CFE or placebo was administered between January and April 2021. Serum uric acid levels after 12 weeks were assessed as the primary outcome, and uric acid were measured before and after 4 weeks of the intervention as secondary outcomes. Blood, urine and body parameters were examined to evaluate the safety of CFE. Results: Thirty-nine subjects completed the trial, and the per protocol set comprised 18 and 21 subjects in the active and placebo groups, respectively. In the single dosing study of CFE on subjects loaded by the purine base-rich diet, no significant changes were observed between the CFE and placebo groups. On the other hand, in the 12-week ingestion study, serum uric acid levels were significantly lower in the CFE group than in the placebo group. Laboratory tests revealed no abnormalities to suggest any side effects of CFE.Conclusions: CFE (100 mg/day) containing 1 mg of luteolin reduced serum uric acid levels. CFE may be beneficial for improving hyperurichemia. Trial Registration: UMIN-CTR: UMIN000042327Foundation: The present study was funded by Oryza Oil & Fat Chemical Co., Ltd. Keywords: Chrysanthemum, luteolin, uric acid, purine base