Beneficial Effect of Heat-Killed Lactic Acid Bacterium Lactobacillus johnsonii No. 1088 on Temporal Gastroesophageal Reflux-Related Symptoms in Healthy Volunteers: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study.

A randomized, placebo-controlled, double-blind, parallel-group clinical study was conducted to examine the effects of ingesting a heat-killed lactic acid bacterium, Lactobacillus johnsonii No. 1088 (LJ88) on temporal gastroesophageal reflux-related symptoms in healthy volunteers. A total of 120 healthy Japanese volunteers of both sexes, aged between 21 and 63 years, whose Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (FSSG) total score was 8 or greater, but who were not diagnosed with functional dyspepsia according to the Rome IV classification, were enrolled. They were randomly assigned to either the LJ88 or placebo group and instructed to ingest the test food (1 billion heat-killed LJ88 or placebo) once a day for six weeks. Gastroesophageal reflux-related symptoms were evaluated using FSSG scores as a primary endpoint. The Gastrointestinal Symptoms Rating Scale (GSRS), stomach state questionnaire, and serum gastrin concentration were used as secondary endpoints. In the FSSG evaluation, the heartburn score was significantly improved at 6 weeks in the LJ88 group compared to the placebo group. No severe adverse events related to the test food were observed. In conclusion, daily ingestion of heat-killed LJ88 improved temporal heartburn symptoms in non-diseased individuals.

Ingesting probiotic yogurt containing Lactiplantibacillus plantarum OLL2712 improves glycaemic control in adults with prediabetes in a randomized, double-blind, placebo-controlled trial.

AIM: The ingestion of Lactiplantibacillus plantarum OLL2712 (OLL2712) cells has been shown to improve glucose metabolism by suppressing chronic inflammation in murine models and clinical studies. This study aimed to clarify the effect of OLL2712 on glycaemic control in healthy adults with prediabetes. MATERIALS AND METHODS: The study was a randomized, double-blind, placebo-controlled, parallel-group design. Adult participants with prediabetes [n = 148, glycated haemoglobin (HbA1c) range: 5.6%-6.4%, age range: 20-64 years] were assigned randomly to placebo or OLL2712 groups (n = 74/group) and administered daily for 12 weeks either conventional yogurt or yogurt containing >5 × 109 heat-treated OLL2712 cells, respectively. In addition, the participants were followed for 8 weeks after the discontinuation of either yogurt. The primary outcome was the changes in HbA1c levels at weeks 12 and 16 by analysis of covariance. RESULTS: The levels of HbA1c and glycoalbumin decreased significantly in both groups at week 12 in comparison with those at week 0, but only in the OLL2712 group at week 16. HbA1c levels decreased significantly at weeks 12 and 16 in the OLL2712 group in comparison with the placebo group (p = .014 and p = .006, respectively). No significant inter- and intragroup differences in HbA1c levels were observed at week 20. CONCLUSIONS: The ingestion of OLL2712 prevents the deterioration of glycaemic control and maintains the HbA1c levels within the normal range in adults with prediabetes; yogurt probably exhibits similar effects, which may contribute to reducing the risk of developing type 2 diabetes.

Effect of Continuous Ingestion of Bifidobacteria and Dietary Fiber on Improvement in Cognitive Function: A Randomized, Double-Blind, Placebo-Controlled Trial.

Bifidobacterium animalis subsp. lactis GCL2505 has been shown to have some positive effects on health, including improved defecation frequency and reduced visceral fat. These effects are thought to be due to GCL2505's unique ability to reach the intestine in a viable form and proliferate after a single intake. This leads to an increased number of intestinal bifidobacteria. This randomized, double-blind, placebo-controlled, parallel-group study was conducted to confirm that intake of GCL2505 and inulin (a prebiotic) improve cognitive function (n = 80). Participants consumed test drinks containing 1 × 1010 colony-forming units of GCL2505 per 100 g and 2.0 g of inulin per 100 g for 12 weeks. The change in cognitive function assessment scores was set as the primary endpoint. There were significant improvements in scores in the neurocognitive index domain, which is an assessment of overall cognitive function, in addition to overall attention, cognitive flexibility, and executive function domains. The intervention significantly increased the number of fecal bifidobacteria and affected the levels of several inflammatory markers. These results suggest that intake of GCL2505 and inulin improves cognitive function by improving the intestinal environment and alleviating inflammation.

Frailty-Preventing Effect of an Intervention Program Using a Novel Complete Nutritional "COMB-FP Meal": A Pilot Randomized Control Trial.

Frailty is a huge concern for the aging population, and dietary nutrition is considered a key factor in the prevention of aging. To solve the problem of frailty in the aging population, we developed a novel dietary intervention program using a novel COMpletely Balanced for Frailty Prevention (COMB-FP) meal, based on the Dietary Reference Intake for Japanese; in addition, we conducted a pilot randomized control trial comparing an exercise program only (control group) with exercise plus the COMB-FP meal program (test group). We included 110 male and female healthy volunteers with pre-frailty or frailty; the trial lasted for 12 weeks. Two daily meals were replaced with the COMB-FP meals during the trial in the test group. Walking speed and cognitive function were significantly improved in the test group compared with the control group. We observed a similar pattern in other frailty-related outcomes, such as occupancy of the microbiome, World Health Organization well-being index (WHO-5), and oxidative stress. Our study might indicate the importance of a well-balanced intake of nutrients for frailty prevention.

Lactobacillus paragasseri SBT2055 Activates Plasmacytoid Dendritic Cells and Improves Subjective Symptoms of Common Cold in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Parallel-Group Comparative Trial.

This study investigated whether Lactobacillus paragasseri SBT2055 (LG2055) activates plasmacytoid dendritic cells (pDCs) and suppresses common cold symptoms in healthy adults. Cell-based experiments showed that a LG2055 treatment upregulated CD86 and HLA-DR expression in pDCs, indicating that LG2055 activates pDCs in vitro. In a subsequent randomized, double-blind, placebo-controlled, parallel-group comparative trial, 200 participants were randomly divided into two groups and consumed three capsules with or without LG2055 once daily for 12 weeks. The primary outcome was the score on a daily physical health questionnaire survey of common cold symptoms. Three participants discontinued the trial and six participants were excluded from the analysis, thus 191 participants (95 in the LG2055 group and 96 in the placebo group) were analyzed. The LG2055 group showed a significantly higher ratio of "without symptoms" responses for runny nose, plugged nose, sneezing, sore throat, hoarseness, and chill than the placebo group. Furthermore, a stratified analysis revealed that LG2055 intake enhanced CD86 and HLA-DR expression in the pDCs of the participants with low secretion rates of salivary secretory immunoglobulin A. These data suggest that LG2055 suppresses the subjective symptoms of the common cold by activating pDCs and improving the host's immune system in healthy adults, especially in immune-weakened individuals (UMIN000049183).

Oral administration of 6-methylsulfinylhexyl isothiocyanate extracted from wasabi is safe and improves the fatigue and sleep of healthy volunteers.

BACKGROUND: This study aimed to conduct a preliminary evaluation of the effects of 6-methylsulfinylhexyl isothiocyanate (6-MSITC) contained in wasabi rhizomes on fatigue and sleep and to examine its safety through overdose study. METHODS: A total of 20 healthy volunteers who were experiencing daily fatigue were given powder containing 6-MSITC (4.8 mg/day of 6-MSITC) extracted from wasabi for 4 weeks. Then, fatigue, sleep, autonomic nervous functioning, stress, and immunity were evaluated. In addition, an overdose safety study of the extract powder (up to 16 mg/day of 6-MSITC for 4 weeks) was performed with 30 healthy volunteers in a double-blind, placebo-controlled method. RESULTS: The powder containing 6-MSITC did not improve fatigue after a mental task, but fatigue before the mental task, sleep, and mood were improved significantly after 4 weeks intake. No changes were observed in the autonomic nerve function, stress, or immune markers. In the overdose safety study, no changes in the parameters ​​or side effects were observed, and the results showed that high doses of the extract powder containing 6-MSITC is safe. CONCLUSION: This study confirmed the possibility that this powder extracted from wasabi that contains 6-MSITC might improve fatigue and sleep. However, because the effectiveness evaluation in this study was a single-arm, open-label study and there was no placebo control group, these points must be considered when interpreting the results. Safety was confirmed in an overdose study of more than three times the amount compared to that in the efficacy evaluation study. In the future, further research should be conducted on its effectiveness for treating fatigue and sleep problems. TRIAL REGISTRATION: UMIN clinical trial registration system, UMIN000049913. Registered 27 December 2022 Retrospectively registered, https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000056818.

Effects of egg yolk choline intake on cognitive functions and plasma choline levels in healthy middle-aged and older Japanese: a randomized double-blinded placebo-controlled parallel-group study.

BACKGROUND: Choline, as a neurotransmitter acetylcholine precursor, is reportedly associated with cognitive function. Although there are several cohort and animal studies on choline-containing foods and cognitive function, only a few interventional studies were reported. Egg yolk is a rich source of different choline-containing chemical forms, such as phosphatidylcholine (PC), lysophosphatidylcholine (LPC), and α-glycerophosphocholine (α-GPC). This study aimed to investigate the effect of consuming 300 mg of egg yolk choline per day on cognitive function of Japanese adults. METHODS: A 12-week, randomized, double-blind, placebo-controlled, parallel-group study was conducted in 41 middle-aged and elderly males and females (43.9% female) aged ≥ 60 years and ≤ 80 years without dementia. Participants were randomly assigned to placebo and choline groups. The choline group received a supplement containing egg yolk choline (300 mg/day), and the placebo group received an egg yolk supplement free from choline for 12 weeks. Assessments of Cognitrax, Trail Making Tests (TMT) part A and B, the MOS 36-Item Short-Form Health Survey (SF-36), the Simplified Japanese Version of the WHO-Five Well-Being Index (WHO-5), and plasma choline levels were performed before and 6 and 12 weeks after supplement intake. In the present study, 19 subjects (9 in the placebo group and 10 in the choline group) were excluded due to the violation of the discontinuation criteria or participant compliance, and 41 subjects were analyzed. RESULTS: The change amount of verbal memory scores and verbal memory test-correct hit (delay) was significantly higher in the choline group than in the placebo group at baseline-6 and baseline-12 weeks. The plasma free choline level was significantly higher in the choline group compared with the placebo group at 6 weeks. Conversely, the choline group showed significantly lower Cognitrax processing speed scores, symbol digit coding testing correct responses, and SF-36 physical quality of life summary scores compared to the placebo group at 6 weeks. CONCLUSIONS: The results suggested that continued 300 mg/day intake of egg yolk choline improved verbal memory, which is a part of cognitive functions. To confirm the observed effects of egg yolk choline, more well-designed and large-scale studies are warranted. TRIAL REGISTRATION: Study protocols were pre-registered in the Clinical Trials Registration System (UMIN-CTR) (UMIN 000045050).

Intake of Lactobacillus paragasseri SBT2055 improves subjective symptoms of common cold during winter season in healthy adults: A randomized, double-blind, placebo-controlled parallel-group comparative study.

Objective: Lactobacillus paragasseri SBT2055 (LG2055) has been reported to show immunostimulating effects. This study aimed to investigate the effects of LG2055 on the subjective symptoms of the physical condition in healthy adults. Materials and methods: In this randomized, double-blind, placebo-controlled, parallel-group comparative study, Japanese individuals aged 20-64 years were recruited. A total of 200 participants were randomly divided into two groups by an independent controller (LG2055 and placebo groups; 100 participants per group). Drinkable yogurts containing LG2055 or lacking LG2055 (placebo) were used as test samples. The participants ingested one bottle of the test sample once a day for 12 weeks. A daily physical health questionnaire survey (about common cold symptoms) was performed as the primary outcome, and immunological and oxidative stress markers in saliva and serum were evaluated as secondary outcomes. Results: In total, 198 participants completed the scheduled intake of the test samples, and five participants were excluded from the final analysis. Consequently, 193 participants (LG2055 group, n = 97; placebo group, n = 96) in the Per-Protocol Set were included in the efficacy analysis. The cumulative days of each symptom were evaluated, and the LG2055 group showed a significantly higher ratio of "without symptom" in runny nose, plugged nose, sneezing, sore throat, hoarseness, cough, headache, feeling tired, and fever than the placebo group, indicating that the incidence rates of common cold symptoms were lower in the LG2055 group. Additionally, changes in the salivary secretory IgA levels were significantly higher, and the serum derivatives of reactive oxygen metabolites levels were significantly lower in the LG2055 group. Conclusion: Our study revealed that intake of LG2055 decreased common cold symptoms and improved immune parameters in healthy adults. This suggests that LG2055 contributes to the maintenance of physical conditions by improving the host immune system. Clinical trial registration: [https://www.umin.ac.jp/ctr/index.htm], identifier [UMIN000045901].

Impact of predischarge nocturnal pulse oximetry (sleep-disordered breathing) on postdischarge clinical outcomes in hospitalized patients with left ventricular systolic dysfunction after acute decompensated heart failure.

Stratifying patients at a high risk for readmission and mortality before their discharge after acute decompensated heart failure (ADHF) is important. Although sleep-disordered breathing (SDB) is prevalent in patients with chronic heart failure, only few studies have investigated the impact of SDB on hospitalized patients with left ventricular (LV) systolic dysfunction after ADHF. Thus, we assessed the prevalence of SDB using nocturnal pulse oximetry and the relation between SDB and clinical events in this patient group. One hundred consecutive patients with LV systolic dysfunction who were hospitalized for ADHF were enrolled in the study. Predischarge nocturnal oximetry was performed to determine if they had SDB (defined as an oxygen desaturation index of ≥5 events/hour with ≥4% decrease in saturation level). Data on death and readmission for ADHF were collected. Forty-one patients had SDB. Complete outcome data were collected in the mean follow-up period of 14.2 months during which 33 events occurred. On multivariate Cox proportional hazards regression analysis, the presence of SDB was a significant independent predictor of postdischarge readmission and mortality (hazard ratio 2.93, p = 0.006). In conclusion, SDB, as determined by predischarge nocturnal oximetry, is prevalent and is an independent predictor of the combined end point of readmission and mortality in hospitalized patients with LV systolic dysfunction after ADHF.

Prevalence and clinical implication of metabolic syndrome in chronic heart failure.

BACKGROUND: Metabolic syndrome (MetS) is a pathological condition with a clustering of metabolic components and is a well-known risk and prognostic factor for ischemic heart disease (IHD). However, the prevalence and clinical significance of MetS remain to be fully elucidated in chronic heart failure (CHF), an important clinical syndrome caused by various cardiac abnormalities. METHODS AND RESULTS: The present nationwide, large-scale clinical study enrolled 3,603 patients with stage C/D CHF from 6 institutes in Japan. First, the prevalence of MetS in CHF patients was demonstrated to be 45% in males and 19% in females, which is more than double compared with the general population in Japan. The CHF patients with MetS were characterized by younger age, higher prevalence of current smoking and drinking, IHD, and hypertensive heart disease, whereas the prevalence of HF with preserved ejection fraction and MetS was higher in elderly female patients. Next, the contribution of the metabolic components (waist circumference, hypertension, glucose intolerance/diabetes mellitus and dyslipidemia) was found to be comparable between the ischemic and the non-ischemic CHF patients. CONCLUSIONS: The prevalence of MetS in CHF patients is more than double compared with the general population in Japan and suggest that the metabolic components may have a substantial effect on the development of both ischemic and non-ischemic CHF.

Estimated glomerular filtration rate is an independent predictor for mortality of patients with acute heart failure.

BACKGROUND: Heart failure is a major public health problem in developed countries including Japan, therefore it is important to estimate the future risk in patients with heart failure. Recently, it has been reported that chronic kidney disease (CKD) is an independent predictor for mortality in chronic heart failure. However, it is unknown whether CKD is an independent predictor for mortality in acute heart failure. We retrospectively investigated the relationship between estimated glomerular filtration rate (eGFR) on admission for acute heart failure and long-term mortality. METHODS: We analyzed 194 patients who were admitted for acute heart failure from January, 2002 to February, 2005. Patients were divided into two groups, high-eGFR group (eGFR <60 ml/min, n=75) and low-eGFR group (eGFR > or =60 ml/min, n=119). eGFR was calculated by equation of MDRD (modification of the diet in renal disease) study. eGFR level <60 ml/min/1.73 m(2) is impaired renal function according to the guidelines of the Japanese Society of Nephrology and of the National Kidney Foundation. Serum B-type natriuretic peptide (BNP) level and left ventricular ejection fraction (LVEF), anemia, age, gender, and etiology of heart failure were also evaluated. Median observation period was 609 days (range: 30-1627). Mean age was 69 years and 138 patients were male. RESULTS: Median eGFR on admission was 74.2 ml/min (range: 5.48-238.7), median BNP level was 840 pg/ml (range: 200-4800), and median LVEF was 36% (range: 11-81%). Forty-two percent of patients had eGFR <60 ml/min of eGFR at the time of coronary care unit admission. Patients with low-eGFR had a significantly lower mortality rate by Kaplan-Meier analysis (log rank test, p=0.013). By Cox's proportional-hazard analysis, eGFR was an independent factor for long-term mortality of acute heart failure (p=0.039). CONCLUSIONS: Lower eGFR at the time of admission could be an independent predictor for mortality of acute heart failure.

Long-term clinical and angiographic follow-up in patients with isolated ostial stenosis of the left coronary artery.

BACKGROUND: Isolated ostial stenosis (IOS) of the left coronary artery is a rare disease of unknown etiology, and the long-term prognosis and angiographic characteristics of affected patients have not been fully studied. METHODS AND RESULTS: The present study investigated 57 patients with stenosis of the left main trunk (LMT) who underwent coronary artery bypass grafting (CABG). They were categorized into 3 groups, based on the angiographic findings: Group I comprised 9 patients with IOS; Group II comprised 12 patients with left coronary ostial stenosis in the presence of distal vessel obstructions; Group III comprised 36 patients with stenosis of LMT excluding ostial stenosis and associated with distal vessel obstruction. The patients underwent serial angiography at 1, 5, and 10 years after CABG. Middle aged women with fewer coronary risk factors were more common in Group I compared with Groups II and III (P<0.01). The patency rate of the internal thoracic artery grafts was significantly higher in Groups II and III than in Group I (P<0.05). In Group I, the percentage stenosis of LMT lesions decreased significantly (P<0.05), but there was no difference in the other groups. CONCLUSIONS: IOS had clinical characteristics and time course distinct from those of atherosclerotic LMT disease.

The frequency of cardiac valvular regurgitation in Parkinson's disease.

To investigate the frequency of cardiac valve regurgitation related with low dose dopamine agonists in patients with Parkinson's disease (PD), echocardiograms were analyzed in 527 consecutive PD patients (448 patients treated with dopamine agonists, 79 patients never treated with dopamine agonists as age-matched controls). The frequency of mild or above mild regurgitation of the aortic valve (AR) was significantly higher in the cabergoline group (13.7%, P < 0.05) compared with the controls (2.5%). Odds ratio adjusted by age and sex for AR was significantly higher in the cabergoline group (OR, 6.45; 95% CI, 1.46-28.60; P = 0.01): odds ratio was significantly higher in patients treated with higher daily doses (OR, 14.41; 95% CI, 3.08-67.38; P = 0.0007) and higher cumulative doses (OR, 15.29; 95% CI, 3.19-73.18; P = 0.0006). No statistical difference was identified in the frequency of the tricuspid and mitral regurgitation. None of the other dopamine agonist groups including pergolide gave higher frequency or higher odds ratio compared with the controls. None of our patients showed severe regurgitation or was operated for valvular heart disease. The question as to whether or not longer duration of low dose dopamine agonist treatment would yield the same results needs further studies.

Insulin response to oral glucose load is associated with coronary artery disease in subjects with normal glucose tolerance.

AIM: The critical role of hyperinsulinemia, independent of hyperglycemia, in the pathogenesis of atherosclerosis has not been fully determined. We investigated the association between secretion patterns of insulin after oral glucose load and the severity of coronary artery disease (CAD) in patients with normal glucose tolerance (NGT). METHODS: We enrolled 116 subjects with NGT from 243 patients who had undergone coronary angiography and a standard 75-g oral glucose tolerance test. The patients were divided into 0-vessel, single-vessel and multi-vessel disease groups on the basis of the severity of CAD. RESULTS: The 2-h insulin levels in the multi-vessel disease group (p=0.005) and the single-vessel disease group (p<0.05) were significantly higher than those in the 0-vessel disease group. Multivariate analysis revealed that the levels of 2-h insulin were an independent variable for the presence of CAD (p=0.02) after adjustment for gender and the presence of each criterion of metabolic syndrome using the definition of the International Diabetes Federation. CONCLUSION: A slight but significant increase in prolonged insulin secretion, which is associated with the early stage of insulin resistance, in subjects with NGT, may play an important role in the pathogenesis of atherosclerosis.

Serum uric Acid as a prognostic predictor in pulmonary arterial hypertension with connective tissue disease.

BACKGROUND: Pulmonary arterial hypertension (PAH) has been identified as a life threatening complication of connective tissue disease. However, the association between serum uric acid (UA) levels and long-term outcome in PAH with connective tissue disease has not been evaluated. We therefore assessed whether serum UA levels are related to the mortality of such patients. METHODS AND RESULTS: We investigated 90 consecutive patients with connective tissue disease who were initially diagnosed with PAH by echocardiography, and assessed the long-term clinical outcome in populations with higher (> or = 4.7 mg/dL) and lower serum UA levels. Kaplan-Meier analysis showed that patients with higher median serum UA values had a significantly worse survival rate for any cause of death (54.5% versus 84.7%, log-rank, P < 0.01) and PAH-related death (72.7% versus 93.4%, log-rank, P < 0.01) than those with low values. Multivariate analysis showed that an elevated serum UA level was an independent predictor for survival (hazard ratio, 1.88, 95% CI [1.24- 2.84], P < 0.01). CONCLUSION: Elevated serum UA levels are associated with a poor prognosis and can serve as a prognostic predictor for patients with PAH secondary to connective tissue disease.

Promoter polymorphism in the CD14 gene and concentration of soluble CD14 in patients with in-stent restenosis after elective coronary stenting.

BACKGROUND: Activated monocytes/macrophages, neutrophils, endothelial cells and smooth muscle cells participate in the restenosis processes. Monocytes/macrophages and neutrophils are activated by lipopolysaccharide (LPS) via CD14. Endothelial cells and smooth muscle cells are also stimulated by soluble CD14 (sCD14)-LPS complexes. METHODS: We tested the hypothesis that C(-260)-->T polymorphism of the CD14 gene and sCD14 might be predictors for in-stent restenosis. We analyzed 129 consecutive patients who underwent elective coronary stenting. The restenosis was defined as > or =50% diameter stenosis at follow-up angiography. RESULTS: The prevalence of the T/T genotype and the concentration of sCD14 were significantly higher in the restenosis group than in the no-restenosis group. This CD14 polymorphism also affected the levels of sCD14, therefore, we divided the patients into four groups. The loss index was 24.8% in C/C or C/T and < or =50th percentile of sCD14, 35.9% in T/T and < or =50th percentile of sCD14, 44.2% in C/C or C/T and >50th percentile of sCD14, and 49.1% in T/T and >50th percentile of sCD14 (P=0.02). The restenosis rate was 10.0%, 26.7%, 26.2% and 50.0% in each group, respectively (P=0.003). In the multivariate analysis, T/T and >50th percentile of sCD14 was the independent predictor for in-stent restenosis. CONCLUSIONS: This study showed that the T/T genotype with a high level of sCD14 is an independent predictor of in-stent restenosis. The activation of monocytes/macrophages, endothelial cells and smooth muscle cells mediated by CD14 and/or sCD14 may play an important role in the restenosis processes.

Effect of thiazolidinediones and metformin on LDL oxidation and aortic endothelium relaxation in diabetic GK rats.

In this study, using GK diabetic rats, we compared the effects of three insulin sensitizers on lipid oxidation and the aortic relaxation response. Eight-week-old rats were treated for 4 wk with either troglitazone or pioglitazone, both of which are thiazolidinediones, or with metformin. Despite the fact that only troglitazone has a similarity in structure to alpha-tocopherol, a potent antioxidant, the level of thiobarbituric acid-reactive substance was lower, and the lag time of the conjugated dienes was longer, in the blood samples from the rats in both troglitazone- and pioglitazone-treated groups. In contrast, another insulin sensitizer, metformin, failed to inhibit the oxidation of blood samples. The aortic vasorelaxation response was increased in both troglitazone- and metformin-treated groups compared with the untreated group. These findings suggest that thiazolidinediones have a beneficial effect on lipid oxidation irrespective of the drug's structural similarity to alpha-tocopherol. It is also suggested that the thiazolidinediones and metformin improve vascular function in diabetes. These effects may play a role in the prevention of atherosclerosis in diabetic patients.

Effects of phase III cardiac rehabilitation programs on health-related quality of life in elderly patients with coronary artery disease: Juntendo Cardiac Rehabilitation Program (J-CARP).

The purpose of this prospective randomized controlled trial was to assess the impact of phase III comprehensive cardiac rehabilitation (CR) on health-related quality of life (HRQOL) in elderly patients with coronary artery disease (CAD). Thirty-eight elderly males (mean age, 70 years) with CAD were stratified as the intervention group (n=20) and the control group (n=18). In the intervention group, patients participated in CR for 6 months, whereas in the control group, they received standard care. Validated questionnaires were obtained to evaluate HRQOL using the Medical Outcome Study Short-Form 36 Health Status Survey (SF-36), State-trait anxiety inventory questionnaire (STAI) and Self-rating Depression Scale (SDS) at baseline and after 6 months. At baseline, scores of SF-36 except for general health, STAI and SDS were not different in either group. After 6 months, in the intervention group, scores of bodily pain, general health, vitality and mental health of SF-36 improved significantly compared with baseline. State anxiety scores also improved significantly (p<0.01), but SDS depression scores were not improved. In the control group, none of the parameters significantly changed. These results indicate that elderly patients with CAD should be vigorously encouraged to pursue CR even in chronic phase III.