Total Technological Consultant Co.

Tokyo, Japan

Total Technological Consultant Co.

Tokyo, Japan
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Kataoka T.,Mimozax Co. | Ogawa S.,Mimozax Co. | Matsumae T.,Mimozax Co. | Yazaki Y.,Monash University | Yamaguchi H.,Total Technological Consultant Co.
Pharmacometrics | Year: 2011

Safety of a dietary supplement containing an Acacia polyphenol preparation (AP) that mainly consists of flavan-3-ols was evaluated in a total of 73 healthy male adult subjects. With the use of a 300 mg-tablet form dietary supplement containing 150 mg of AP as the study diet, 2 each single-dose safety studies (Studies I and II) and 4-week repeatedly dosing safety studies (Studies III and IV) were sequentially performed. Five subjects each were orally administered with a single dose of 250, 500, 750 and 1,000 mg of AP (Study I) and that of 1,500 mg of AP (Study II). Thereafter, 11 subjects each received 250 and 500 mg of AP/day for 4 weeks (Study III) and, finally, 11 and 14 subjects received 750 and 1,000 mg of AP/day, respectively, for 4 weeks (Study IV). The follow-up period for Studies I and II was 1 week after dosing and that for Studies III and IV extended to 2 weeks after the end of 4-week intervention. Throughout these 4 safety studies, all doses of AP were well tolerated. There was no subject who discontinued the study diet nor who had any study diet-related laboratory abnormalities. While most of self-reported adverse events were unrelated to the study diet, a possible relationship of a total of 4 mild and transient diarrhea events experienced by 2 subjects each in 250 and 500 mg of AP/day groups with the study diet was unable to be ruled out. The results of study group-based analyses showed that there were no clinically significant changes from baseline of any physical and laboratory test parameters throughout the 4 studies. It is, therefore, concluded that 4-week intake of an AP dietary supplement in daily doses up to 1,000 mg of AP was safe in healthy male adults.

Morita M.,Kyowa Hakko Bio Co. | Iizuka M.,Total Technological Consultant Co. | Morishita K.,Kyowa Hakko Bio Co. | Ochiai M.,Kyowa Hakko Bio Co. | And 3 more authors.
Japanese Pharmacology and Therapeutics | Year: 2013

Background: Orally-administered L-ornithine (Orn) is metabolized by ornithine-δ-amino-transferase (OAT). In humans, a deficiency in OAT results in gyrate atrophy of the choroid and retina, an autosomal recessive trait characterized by hyperornithinemia. However it is unknown whether long-term supplementation of L-ornithine hydrochloride (ORN•HCl) affects blood Orn kinetics and retinal function. The aim of the current study was to determine the influence of orally-administered ORN•HCl on metabolic changes and clinical health status in healthy subjects. Methods: In an open-label trial, 16 healthy subjects received 3.0 g/d of ORN•HCl for 3 months. Plasma Orn, clinical and biological indices were measured. Pharmacokinetic parameters including AUC0-6h, Cmax, Cmin, and T max following 1.0 g oral ORN•HCl loading, and changes in retinal function by using flash electroretinography (ERG) were also evaluated before and after the study period. Results: When compared with the baseline value, slight but significant decreases in basal levels of plasma Orn were observed after ORN•HCl intake. The ORN•HCl loading test increased plasma Orn concentrations, indicating a significant reduction in Cmax after the 3-month study period compared with the baseline result. The other pharmacokinetic parameters and ERG results had not changed. None of the subjects experienced clinically relevant or any side effects. Conclusions: These observations indicated that ORN•HCl supplementation increased plasma Orn levels transiently but did not cause Orn accumulation or affect retinal function in healthy people.

Ogawa S.,Mimozax Co. | Matsumae T.,Mimozax Co. | Kataoka T.,Mimozax Co. | Yazaki Y.,Monash University | Yamaguchi H.,Total Technological Consultant Co.
Experimental and Therapeutic Medicine | Year: 2013

Numerous in vitro and animal studies, as well as clinical trials have indicated that plant-derived polyphenols exert beneficial effects on glucose intolerance or type 2 diabetes. This clinical study aimed to investigate the effects of acacia polyphenol (AP) on glucose and insulin responses to an oral glucose tolerance test (OGTT) in non-diabetic subjects with impaired glucose tolerance (IGT). A randomized, double-blind, placebo-controlled trial was conducted in a total of 34 enrolled subjects. The subjects were randomly assigned to the AP-containing dietary supplement (AP supplement; in a daily dose of 250 mg as AP; n=17) or placebo (n=17) and the intervention was continued for 8 weeks. Prior to the start of the intervention (baseline) and after 4 and 8 weeks of intervention, plasma glucose and insulin were measured during a two-hour OGTT. Compared with the baseline, plasma glucose and insulin levels at 90 and/or 120 min, as well as the total area under the curve values during the OGTT (AUC0→2h) for glucose and insulin, were significantly reduced in the AP group, but not in the placebo group after intervention for 8 weeks. The decline from baseline in plasma glucose and insulin at 90 or 120 min of the OGTT for the AP group was significantly greater compared with that of the placebo group after 8 weeks of intervention. No AP supplement-related adverse side-effects nor any abnormal changes in routine laboratory tests and anthropometric parameters were observed throughout the study period. The AP supplement may have the potential to improve glucose homeostasis in subjects with IGT.

Nagaoka I,Juntendo University | Nabeshima K.,Everlife Co. | Murakami S.,Everlife Co. | Yamamoto T.,Total Technological Consultant Co. | And 3 more authors.
Experimental and Therapeutic Medicine | Year: 2010

We aimed to investigate whether a supplementary diet containing chicken comb extract (CCE) rich in hyaluronic acid (HA) has an effect on pain and other symptoms, as well as cartilage type IIcollagen (CII) metabolism in patients with knee osteoarthritis (OA). Arandomized double-blind placebo-controlled study was conducted in 43 subjects with knee OA(Kellgren/Lawrence grade, mainly 1-2) comprising 22 patients receiving concurrent exercise therapy (ET) and 21 without ET(referred as ET-receivers and ET-unreceivers, respectively). Subjects were randomized to a CCE-containing diet (active diet) group administered a dose of 1,800 mg/day (containing 630mg of CCE and approximately 60 mg of HA) and a placebo group, and the intervention was continued for 16 weeks. Symptomatic efficacy was evaluated based on the Japanese Orthopaedic Association clinical trials response criteria (JOAresponse criteria) and visual analog scales (VAS) before (baseline) and during the intervention. To further examine its effect on CIImetabolism, the levels of two degradation biomarkers (CTX-IIand C2C) and one synthesis biomarker (CPII) were measured using urine or serum samples. Nineteen subjects (10 ET-receivers and 9 ET-unreceivers) in the active diet group and 21 subjects (10 ET-receivers and 11ET-unreceivers) in the placebo group were finally included in the study. Compared to the baseline, subscale scores of the JOAresponse criteria, i.e., 'pain/walking function', 'pain/step-up and -down function' and 'aggregate total symptoms' were more intensely improved in the active diet group than in the placebo group. Moreover, subgroup analyses of ET-receivers and ET-unreceivers indicated that significant improvements were restricted to ET-receivers of the active diet group. Furthermore, VAS assessment indicated that the 'pain on pressing' subscale was significantly improved in ET-receivers of the active diet group. In addition, analysis of CIIbiomarkers revealed that serum C2Cand CPIIlevels, but not the urinary CTX-IIlevel, were increased in the active diet group. Notably, both urinary CTX-II/serum CPIIand serum C2C/serum CPIIratios were reduced in the active diet group (particularly ET-unreceivers), suggesting that CIIsynthesis was relatively increased compared to CIIdegradation in the active diet group. Finally, no diet-related side effects were observed. The CCE-containing diet is likely to be effective in relieving symptoms in patients with knee OA. In addition, it has the potential to improve the balance of CIIdegradation/synthesis in knee OA.

Ishijima M.,Juntendo University | Watari T.,Juntendo University | Naito K.,Juntendo University | Kaneko H.,Juntendo University | And 9 more authors.
Arthritis Research and Therapy | Year: 2010

Introduction: We tested the hypothesis that there exist relationships between the onset of early stage radiographically defined knee osteoarthritis (OA), pain and changes in biomarkers of joint metabolism.Methods: Using Kellgren-Lawrence (K/L) grading early radiographic knee OA (K/L 2) was detected in 16 of 46 patients. These grades (K/L 1 is no OA and K/L 2 is early OA) were divided into two groups according to the presence or absence of persistent knee pain. Sera (s) and urines (u) were analysed with biomarkers for cartilage collagen cleavage (sC2C and uCTX-II) and synthesis (sCPII), bone resorption (uNTx) and synovitis (hyaluronic acid: sHA).Results: sCPII decreased and sC2C/sCPII, uCTX-II/sCPII and sHA increased with onset of OA (K/L 2 versus K/L 1) irrespective of joint pain. In contrast, sC2C and uCTX-II remained unchanged in early OA patients. Of the patients with K/L grades 1 and 2 sC2C, sCPII, sHA, uNTX and uCTX-II were all significantly increased in patients with knee pain independent of grade. Among the K/L grade 2 subjects, only uCTX-II and uCTX-II/sCPII were increased in those with knee pain. In grade 1 patients both sC2C and sCPII were increased in those with knee pain. No such grade specific changes were seen for the other biomarkers including sHA.Conclusions: These results suggest that changes in cartilage matrix turnover detected by molecular biomarkers may reflect early changes in cartilage structure that account directly or indirectly for knee pain. Also K/L grade 1 patients with knee pain exhibit biomarker features of early OA. © 2011 Ishijima et al.; licensee BioMed Central Ltd.

Nakasone Y.,Kenkoukazoku Inc | Nakamura Y.,Medical Corporation Keiaikai Nakamura Hospital | Yamamoto T.,Total Technological Consultant Co. | Yamaguchi H.,Total Technological Consultant Co.
Experimental and Therapeutic Medicine | Year: 2013

Numerous clinical studies have used differing garlic preparations leading to controversial results with regard to the hypotensive effect of garlic. This randomized, double-blind, placebo-controlled study was designed to determine the effect of a traditional Japanese garlic homogenate-based supplementary diet (GH diet) product on blood pressure (BP) in subjects with prehypertension and in those with mild hypertension. In total, 34 eligible subjects with prehypertension and 47 with mild hypertension were treated with a daily dose of GH diet (300 mg as dried garlic homogenate; n=16 and 23, respectively) or placebo (n=18 and 24, respectively) for 12 weeks. Of these, 32 prehypertensive subjects (15 on the GH diet and 17 on the placebo) and 40 mildly hypertensive subjects (19 on the GH diet and 21 on the placebo) completed the study and were subjected to efficacy analyses. Systolic and diastolic BPs were monitored at weeks 4, 8 and 12 during the treatment and at post-week 4 following the termination of the treatment. The GH diet induced significant reductions of systolic BP (of between 6.6 and 7.5 mmHg) and diastolic BP (of between 4.6 and 5.2 mmHg) compared with the placebo subsequent to 8 and 12 weeks of treatment. A 12-week intake of the GH diet did not cause any clinically problematic side-effects. We conclude that the GH diet was well tolerated, and had a clinically relevant hypotensive effect in adults with mild hypertension, but not in those with prehypertension.

Yoshimura M.,Juntendo University | Aoba Y.,Juntendo University | Naito K.,Juntendo University | Watari T.,Juntendo University | And 6 more authors.
Experimental and Therapeutic Medicine | Year: 2012

Much of our focus of attention has been on sub clinical or subtle joint pain experienced by healthy soccer players. The present study aimed to determine at which joint such subclinical pains are the most prominent, and to examine the pain-relieving effect of a chicken comb extract (CCE)-containing supplement product (test product) on these athletes. A total of 46 collegiate soccer players, consisting of 24 leading and 22 substitute players, belonging to a university soccer team were enrolled for measuring the pains at 4 different joints (ankle, knee, hip and shoulder) using 3 pain subscales of a 100-mm visual analog scale (VAS) ('pain at rest', 'pain on pressing' and 'pain on moving'), and participated in a prospective, double-blind, controlled study. A total of 23 subjects each received the test product (4,800 mg/day) (test group) and placebo (placebo group) for 12 weeks. VAS pain scores of individual joints were evaluated at baseline and following 4, 8 and 12 weeks of the intervention. VAS scores for the 'pain on moving' subscale in 46 enrolled subjects were highest at the ankle joint, and thus the values (abbreviated as 'pain scores') were used as a parameter for efficacy assessment of the test product. Compared to the baseline, the pain scores were significantly decreased for the dominant foot (but not for the non-dominant foot) in the total subpopulation (at week 4; p<0.01) and the leading player subpopulation (at week4; p<0.01 and at week 12; p<0.05) in the test group (n=19 and 11, respectively). In comparison between the test product and placebo groups, the pain scores were significantly changed for the dominant foot (p<0.05) at week 4 in the total subpopulation and at week 12 in the leading player subpopulation in the test group. Thus, subclinical joint pain is most prominently observed at the ankle joint of the dominant foot in healthy young soccer players and may be improved by the daily intake of the CCE-containing supplement.

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