Search

Background: Excessive ingestion of fructose can lead to obesity and related diseases. Eucalyptus leaf extract (ELE) contains oenothein B, which inhibits intestinal fructose absorption.Objective: The antiobesity effects of ELE containing oenothein B were evaluated in healthy Japanese whose body mass index (BMI) was ≥ 23 and < 30 kg/m2.Methods: A randomized, placebo-controlled, double-blind, parallel-group study was performed to evaluate the effect of ELE consumption, for 12 weeks at a 3.38 mg/day dose of oenothein B, on the abdominal visceral fat area (VFA) as the primary outcome. Results were compared to those of a placebo group.Results: Of the 721 individuals who underwent screening, 198 were randomly allocated into two groups. A total of 95 subjects in the placebo group and 94 in the intervention group were established as the per-protocol set. VFA in the intervention group significantly decreased compared to that in the placebo group 12 weeks after initiating intervention. This reduction in VFA was considered to have clinical significance. Among the secondary outcomes, VFA, waist circumference, and muscle mass after 8 weeks, as well as body weight and BMI after 12 weeks, were significantly lower in the intervention group compared to the placebo group.Conclusion: ELE containing oenothein B may be effective against obesity and related diseases by reducing VFA levels. Keywords: human trial; Eucalyptus globulus; oenothein B; polyphenol; hydrolyzable tannin; ellagitannin; dietary fructose consumption; dietary survey; Calorie and Nutrition Diary; glucose transporter 5

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 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

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: UMIN000041295 Foundation : 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

Background: The seaberry is a yellow berry cultivated in China, Northern Europe, and West Asian countries. Numerous biological activities of seaberries have been reported, and we recently found that ursolic acid and a flavonoid in seaberry extract (SBE) suppressed the contraction of bladder muscle specimens and collagen gel containing bladder smooth muscle cells. However, the influence of SBE on urinary problems of Japanese adults has not been investigated. Therefore, we conducted a clinical trial of SBE supplementation in Japanese subjects with mild urinary dysfunction. Methods: We examined the effect of SBE (200 or 400 mg daily) containing ursolic acid (0.18 or 0.36 mg) in a randomized double-blind placebo-controlled study. Capsules containing SBE or placebo were administered for 8 weeks to Japanese men and women with mild urinary dysfunction. After 4 and 8 weeks of treatment, urinary symptoms were evaluated by using the King’s Health Questionnaire (KHQ) and the overactive bladder syndrome score (OABSS). Results: There was significant improvement of the KHQ emotion domain score after intake of 400 mg/day of SBE for 8 weeks compared with placebo. The answers to “Does your bladder problem make you depressed?” and “Does your bladder problem make you feel bad about yourself?” were significantly improved by SBE (400 mg/day) at 8 weeks. In the OABSS, the item “How often do you have a sudden desire to urinate, which is difficult to defer?” was significantly improved by SBE compared with placebo. Laboratory tests did not reveal any abnormalities suggesting adverse effects SBE. Conclusions: Intake of SBE (400 mg/day for 8 weeks) improved several emotional parameters related to urinary dysfunction. SBE may be useful for reducing moderate urinary symptoms. Keywords : King’s health questionnaire; overactive bladder syndrome score; seaberry; ursolic acid; overactive bladder; urination; micturition