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Kawasaki K.,House Wellness Foods Corporation | Fukuhara I.,Fukuhara Clinic | Muroyama K.,House Wellness Foods Corporation | Murosaki S.,House Wellness Foods Corporation
Japanese Pharmacology and Therapeutics | Year: 2017

Background: The aim of this study was to demonstrate the effects of this combination on serum liver enzymes, emotional states, and inflammatory markers to clarify the contribution of systemic inflammation to serum liver enzymes and emotional states. Methods: Eighty healthy participants with moderately high body mass index were assigned to a 12-week treatment with a combination of hot water extract of Curcuma longa (400 μg as bisacurone) and curcumin (30 mg) or placebo in a randomized, double-blind, placebocontrolled design. Results: For all participants, serum liver enzyme levels did not significantly differ between the combination and the placebo groups. However, for participants whose serum liver enzyme levels were in the borderline range, decreases in serum liver enzymes (alanine aminotransferase, aspartate aminotransferase, and γ-glutamyltransferase) were significantly greater in the combination group than in the placebo group (P=0.047, 0.035, and 0.0014, respectively). Although there were no significant differences in changes in inflammatory marker levels between the placebo and the combination groups, these levels showed a significant decrease in participants whose serum liver enzyme levels had improved. The combination group showed a significantly greater decrease in fatigue scores on the Profile of Mood States (POMS) than the placebo group (P=0.0007). Conclusions: This study showed that a combination of hot water extract of Curcuma longa and curcumin significantly decreased serum liver enzyme levels of participants with borderline serum liver enzyme levels, possibly through the suppression of systemic inflammation. Additionally, the combination significantly decreased POMS fatigue scores.


Fukuhama C.,MG Pharma Inc. | Tsuruta R.,MG Pharma Inc. | Fukuhara I.,Fukuhara Clinic
Japanese Pharmacology and Therapeutics | Year: 2016

Globin digest (GD), an oligopeptide mixture derived from edible globin proteins, used as Food for Specified Health Use (FOSHU) in Japan, Health Food in China and Functional Food in Korea. We have reported that the combination of magnesium hydroxide and GD has the antihypertensive effect in spontaneously hypertensive rats and protective effect against stroke in stroke-prone spontaneously hypertensive rats. The present clinical study attempted to evaluate the hypotensive effect and the safety of magnesium hydroxide and GD in a double blind, placebo-controlled, parallel group study. The study was conducted on 42 subjects with mild hypertension (male/female =16/26). These subjects were randomly divided into two groups. The test group ingested the supplements containing magnesium hydroxide 700 mg/day (as Mg 292 mg/day) and GD 1000 mg/day. Control group ingested this active placebo. Each group was given 6 tablets by orally twice a day for 8 weeks. After 8 weeks ingestion, the systolic blood pressure and the diastolic blood pressure of the test group were significantly suppressed 7.6 mmHg (P<0.01) and 3.1 mmHg (P<0.05) compared to 0 week values. Any abnormal changes in clinical findings such as blood test, urinalysis and physical examination were not observed. These results demonstrated that the supplements containing of magnesium hydroxide and globin digest are safety and useful for suppressing blood pressure in the subjects with mild hypertension. (Jpn Pharmacol Ther 2016 ; 44 : 101-11).


Fukuhara I.,Fukuhara Clinic | Ikenaga T.,Otsuka Pharmaceutical Factory Inc. | Noguchi H.,Otsuka Pharmaceutical Factory Inc. | Kohashi C.,Otsuka Pharmaceutical Factory Inc. | And 4 more authors.
Japanese Pharmacology and Therapeutics | Year: 2013

Objectives: The aim of the present study was to investigate the effect of cooked rice with β-glucan enriched barley on postprandial glucose response and its second-meal effect. Methods: The study was conducted in randomized crossover design with twenty healthy subjects whose fasting blood glucose was normal level. Subjects consumed test meals at breakfast and blood glucose, insulin and free fatty acid were measured for 120 min after the breakfast. For a subsequent lunch, they consumed standardizes meals and blood glucose was measured for 120 min after the lunch. Results: Cooked rice with β-glucan enriched barley lowered the blood glucose and insulin incremental areas under the curve (IAUC) (0-120 min) at breakfast and the blood glucose IAUC (0-120 min) at a subsequent lunch (P<0.05). The blood free fatty acid was not changed after ingestion of the test meals at breakfast. Conclusions: These findings suggested that cooked rice with β-glucan enriched barley contributed to postprandial glucose response and its second-meal effect. The present study suggested that cooked rice with β-glucan enriched barley has potential to an advantage for diabetes care.


Kato M.,Otsuka Pharmaceutical Factory Inc. | Inoue S.,Otsuka Pharmaceutical Factory Inc. | Sato I.,Otsuka Pharmaceutical Factory Inc. | Kohda N.,Otsuka Pharmaceutical Factory Inc. | And 3 more authors.
Japanese Pharmacology and Therapeutics | Year: 2016

Objectives The aim of the study was to investigate the effects of food containing asparagus extract (ONR-8) on sleep conditions in evening-type individuals. Methods We conducted a randomized, double-blind, placebo-controlled, crossover, exploratory study in 20 healthy male volunteers who had an evening-type chronotype. In Period 1, participants were randomly assigned to take either ONR-8 or placebo for 2 weeks. In Period 2, the treatments were reversed in a crossover manner. To assess performance, participants took the Psychomotor Vigilance Test (PVT) twice: once in the morning and once after lunch at 0, 1, and 2 weeks of treatment. They also completed the Athens Insomnia Scale (AIS), the Epworth Sleepiness Scale (ESS), a visual analogue scale (VAS) for morning appetite, the Morningness- Eveningness Questionnaire (MEQ), and SF-36. In addition, autonomic nerve function and expression of Heat Shock Protein (HSP) 70 mRNA in peripheral blood leukocytes were measured. Participants were asked to complete the OSA sleep inventory MA version during the study period and to record sleep parameters by actigraphy for 3 days prior to intake and continuously during the study period. Results The AIS score during the period of ONR-8 intake was significantly improved as compared with the placebo intake period. When we analyzed the PVT data excluding participants who fell asleep during the test, a significantly faster reaction time on the PVT after lunch was observed during the intake of ONR-8. There were no adverse clinical events throughout the study period. Conclusions These results suggest that ONR-8 improved sleep and daytime performance evening-type individuals.


Ukawa Y.,Central Research Institute ITO EN Ltd. | Sagesaka Y.,Central Research Institute ITO EN Ltd. | Hatakeyama Y.,New Drug Research Center Inc. | Noro A.,New Drug Research Center Inc. | Fukuhara I.,Fukuhara Clinic
Japanese Pharmacology and Therapeutics | Year: 2013

Objective: We examined the effect of catechins with a galloyl moiety to reduce dietary lipid absorption in humans. Methods: A randomized double-blind placebo-controlled crossover study was conducted. The beverage (340 mL/bottle) contained 190.9 mg of tea catechins with a galloyl moiety. Fifteen healthy adult subjects were randomly divided into two groups. Group A was requested to consume the drinks, containing catechins with a galloyl moiety, everyday for 10 days and then the placebo for 10 days, after an 11 day interval between these intake periods. On the contrary, Group B consumed the placebo first for 10 days and then the catechin drinks for 10 days, after an 11 day interval between the periods. Each subject in the catechin group was given 3 bottles of the test beverage/day and each subject in the placebo group was given 3 bottles of the placebo beverage/day. During the treatment period, subjects were given the same menu (Male : 2244±35.6 kcal, 84±0.6 g lipids, Female : 1944±35.6 kcal, 66±0.6 g lipids) at each meal. On the last 3 days of each treatment period, feces were collected in order to measure the excretion of lipids. Results: Lipid excretion into feces was found to be significantly higher in the test beverage consumption cases than in the placebo beverage ones on third day. Serum total cholesterol and LDL cholesterol were significantly lower in the test beverage consumption cases than in the placebo beverage ones. Conclusions: Our present observations suggest that consumption of catechins with a galloyl moiety could increase lipid excretion into feces.


Egawa K.,Suntory Wellness Ltd. | Yoshimura M.,Suntory Wellness Ltd. | Kanzaki N.,Suntory Wellness Ltd. | Nakamura J.,Suntory Wellness Ltd. | And 3 more authors.
Japanese Pharmacology and Therapeutics | Year: 2012

Objectives: The objective of this study was to evaluate the effect of long-term consumption of green tea containing quercetin glucoside on body fat accumulation and the safety in obese subjects. Methods: We performed a randomized double-blind, placebo-controlled trial on subjects (81 men and 119 women) aged from 20 to 65 years old with 25≦ body mass index (BMI) <30 kg/m 2. They were randomly assigned into two groups and consumed the beverages containing 0 mg or 110 mg of quercetin glucoside for 12 weeks. Results: Both total fat area and visceral fat area were significantly reduced in test group compared with placebo group. No adverse effect related to the test beverage containg quercetin glucoside was observed in this study. Conclusions: The results of this study suggest that the long-term consumption of green tea containing quercetin glucoside reduced body fat in safe, and could be useful for prevention and amelioration of obesity and metabolic syndrome.


Saito S.,Kao Corporation | Fukuhara I.,Fukuhara Clinic | Osaki N.,Kao Corporation | Nakamura H.,Mitsukoshi Health and Welfare Foundation | Katsuragi Y.,Kao Corporation
Journal of Oleo Science | Year: 2016

A randomized, double-blind controlled, parallel-group designed trial was performed to investigate the effect of alpha linolenic acid (ALA)-enriched diacylglycerol (DAG) on visceral fat area (VFA) in obese subjects. One hundred eighty-four obese subjects were recruited and randomly allocated to two groups consuming either 2.5 g/d control triacylglycerol (TAG) or ALA-DAG for 12 wk. A 4-wk observation period followed the 12-wk consumption period. One hundred seventy-seven subjects (N=89 in the TAG group, N=88 in the ALA-DAG group) completed the study. The change in VFA at 12-wk from baseline, as the primary outcome, was significantly lower in the ALA-DAG group than in the TAG group. The reduction in VFA was significantly correlated with the baseline VFA. Body weight and waist circumference, as the secondary measures, were also significantly lower in the ALA-DAG group than in the TAG group. The reduction in the VFA was significantly correlated with body weight reduction, suggesting that the VFA reduction was a contributing factor preventing weight gain. Safety parameters and the incidence of adverse events did not differ significantly between groups. In conclusion, ALA-DAG could be useful for reducing VFA and concomitantly suppressing weight gain with no side effects. © 2016 by Japan Oil Chemists’ Society.


Nagatomo A.,Morishita Jintan Co | Nishida N.,Morishita Jintan Co | Fukuhara I.,Fukuhara Clinic | Noro A.,New Drug Research Center Inc | And 3 more authors.
Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy | Year: 2015

Background: Obesity has become a great problem all over the world. We repeatedly screened to find an effective food to treat obesity and discovered that rosehip extract shows potent antiobesity effects. Investigations in mice have demonstrated that rosehip extract inhibits body weight gain and decreases visceral fat. Thus, the present study examined the effect of rosehip extract on human body fat in preobese subjects. Methods: We conducted a 12-week, single-center, double-blind, randomized, placebo-controlled study of 32 subjects who had a body mass index of ≥25 but <30. The subjects were assigned to two random groups, and they received one tablet of placebo or rosehip that contained 100 mg of rosehip extract once each day for 12 weeks with no dietary intervention. Abdominal fat area and body fat percent were measured as primary outcomes. The other outcomes were body weight and body mass index. Results: Abdominal total fat area, abdominal visceral fat area, body weight, and body mass index decreased significantly in the rosehip group at week 12 compared with their baseline levels (P<0.01) after receiving the rosehip tablet intake, and the decreases in these parameters were significantly higher when compared with those in the placebo group. Additionally, body fat percent tended to decrease compared with the placebo group and their baseline level. Moreover, the abdominal subcutaneous fat area was significantly lower in the rosehip group than in the placebo group at week 12 after the initiation of intake (P<0.05). In addition, there were no abnormalities, subjective symptoms, and findings that may indicate clinical problems during the study period. Conclusion: These results suggest that rosehip extract may be a good candidate food material for preventing obesity. © 2015 Nagatomo et al.


Ishida Y.,Calpis Co. | Shibata Y.,Calpis Co. | Fukuhara I.,Fukuhara Clinic | Yano Y.,New Drug Development Research Center Inc. | And 2 more authors.
Bioscience, Biotechnology and Biochemistry | Year: 2011

A double-blind, placebo-controlled, randomized clinical trial was conducted to evaluate the effects of ingesting an excess of tablets containing casein hydrolysate, incorporating angiotensin I-converting enzyme (ACE) inhibitory peptides such as Val-Pro-Pro (VPP) and Ile-Pro-Pro (IPP), in subjects with blood pressure ranging from normal to mild hypertension. A total of 48 subjects were given either 5 times more than the effective amount of casein hydrolysate or a placebo in tablet form for 4 weeks. In the active group, systolic blood pressure (SBP) decreased significantly as compared with the placebo group. In stratified analysis, however, this antihypertensive effect was not found in normotensive subjects. In addition, neither an acute or nor an excessive reduction in blood pressure nor clinically important adverse events were observed in this study. These findings suggest that intake of a 5-fold excess of tablets containing casein hydrolysate can lead to a mild improvement in hypertension without side effects.


PubMed | Morishita Jintan Co, Fukuhara Clinic and New Drug Research Center Inc.
Type: | Journal: Diabetes, metabolic syndrome and obesity : targets and therapy | Year: 2015

Obesity has become a great problem all over the world. We repeatedly screened to find an effective food to treat obesity and discovered that rosehip extract shows potent anti-obesity effects. Investigations in mice have demonstrated that rosehip extract inhibits body weight gain and decreases visceral fat. Thus, the present study examined the effect of rosehip extract on human body fat in preobese subjects.We conducted a 12-week, single-center, double-blind, randomized, placebo-controlled study of 32 subjects who had a body mass index of 25 but <30. The subjects were assigned to two random groups, and they received one tablet of placebo or rosehip that contained 100 mg of rosehip extract once each day for 12 weeks with no dietary intervention. Abdominal fat area and body fat percent were measured as primary outcomes. The other outcomes were body weight and body mass index.Abdominal total fat area, abdominal visceral fat area, body weight, and body mass index decreased significantly in the rosehip group at week 12 compared with their baseline levels (P<0.01) after receiving the rosehip tablet intake, and the decreases in these parameters were significantly higher when compared with those in the placebo group. Additionally, body fat percent tended to decrease compared with the placebo group and their baseline level. Moreover, the abdominal subcutaneous fat area was significantly lower in the rosehip group than in the placebo group at week 12 after the initiation of intake (P<0.05). In addition, there were no abnormalities, subjective symptoms, and findings that may indicate clinical problems during the study period.These results suggest that rosehip extract may be a good candidate food material for preventing obesity.

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