There was no improvement in efficacy with talactoferrin alfa in patients with advanced NSCLC whose disease had failed two or more previous regimens.

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: 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

Objective: Acacia bark-derived proanthocyanidins exhibit antioxidant, anti-inflammatory, anti-diabetic, hypotensive effects, and improving skin condition, in addition to beneficial effects on blood glucose. Herein, we evaluated the effects of acacia bark-derived proanthocyanidins on fasting and postprandial blood glucose levels in healthy Japanese adults with fasting blood glucose (FBG) levels between 110–125 mg/dL.Methods: Subjects were randomly allocated into 2 groups (n = 33 per group) and consumed 6 tablets/day of either tablets of acacia bark extract containing proanthocyanidins (Acacia group) or placebo for 12 weeks. Evaluation points were at the screening, and after 4-week (4w), 8-week (8w), and 12-week intervention (12w). The primary outcome was FBG level at 12 w, whereas the secondary outcomes were FBG level at 4w and 8w, the FBG changes from Scr to each-week intervention, the percentage of subjects with FBG levels below 110 mg/dL after 12 w, the measured value and the change value from Scr to each-week intervention of HbA1c, the measured value and the change value from Scr to each-week intervention of postprandial blood glucose levels.Results: A total of 33 subjects (18 men, 15 women) from each group were analyzed. The Acacia group had significantly lower FBG levels at 8 and 12 w than the placebo group (P = 0.030 and P = 0.014, respectively). The percentage of subjects with FBG <110 mg/dL at 12 w was marginally higher in the Acacia group than in the placebo group (P = 0.079). HbA1c at 12 w was significantly lowered in the Acacia group compared to the placebo group (P = 0.015).Conclusions: Acacia bark-derived proanthocyanidins were confirmed to have FBG-lowering effects.Trial registration: UMIN000039414Foundation: Acacia-No-Ki Co.,Ltd.Keywords: Acacia bark extract, Proanthocyanidins, Fasting blood glucose level, HbA1c

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,