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Supplementation with cassis polyphenol has no effect on menopausal symptoms in healthy middle-aged women: A randomized, double-blind, parallel-group, placebo-controlled trial.
Ohtsuka, M, Yamaguchi, T, Oishi, S, Misawa, K, Suzuki, A, Hibi, M, Terauchi, M
Nutrition research (New York, N.Y.). 2024;:14-22
Abstract
Hormonal changes during the menopause transition may lead to vasomotor symptoms, including hot flashes (HFs) and neuropsychiatric symptoms such as anxiety and irritability. We hypothesized that the effects of cassis polyphenol (CaP) to improve microcirculation and vasorelaxation may alleviate menopausal symptoms. We performed a randomized, double-blind, parallel-group, placebo-controlled trial involving 59 healthy women (mean [standard deviation] age, 51.3 [4.3] years; body mass index, 20.8 [2.6] kg/m2). Participants experiencing subjective menopausal symptoms consumed CaP tablets (400 mg/d, CaP group) or placebo tablets (placebo group) for 4 weeks. Participants were evaluated using questionnaires at baseline, during the 4-week intervention period, and during a 2-week postinterventional observation period. The primary objective was to evaluate the effects of supplementation with CaP on HFs in healthy Japanese women with menopausal symptoms. Additional assessments included the modified Kupperman menopausal index, World Health Organization-5 Well-Being Index, World Health Organization quality-of-life 26-item index, State-Trait Anxiety Inventory (anxiety and trait components), and Oguri-Shirakawa-Azumi sleep inventory (middle-aged and elderly versions). During the 4-week intervention period, no significant between-group differences were detected in the HF frequency, HF score, sweating frequency, menopausal symptoms, quality of life, anxiety, or sleep. During the 2-week postintervention observational period, the HF score and sweating frequency were significantly decreased in the CaP group compared with the placebo group. These findings suggest that twice daily intake of CaP for 4 weeks does not alleviate menopause symptoms, but the improvement observed in the CaP intake group during the postintervention period warrants confirmation through further large-scale studies.
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2.
Effect of Flavanol-Rich Cacao Extract on the Profile of Mood State in Healthy Middle-Aged Japanese Women: A Randomized, Double-Blind, Placebo-Controlled Pilot Study.
Murakami, R, Natsume, M, Ito, K, Ebihara, S, Terauchi, M
Nutrients. 2023;(17)
Abstract
To investigate the effects of flavanol-rich cacao extract on healthy middle-aged women's fatigue and mood conditions, we conducted a randomized, double-blind, placebo-controlled study in women aged 40-60 years who had reported fatigue and had shown high levels of a serum oxidative stress marker. We randomized the participants (n = 60) into equal groups receiving either a beverage containing cacao flavanols (240 mg/200 mL/day) or a placebo for 8 weeks. Before and after the 8-week treatment, we determined the participants' Chalder fatigue scale (CFS) scores, various mood states, autonomic nervous system (ANS) activity levels, and their ANS balance. The results demonstrated that among the mood states, the indicators of negative mood (e.g., depression, fatigue, and anger) and the total mood disturbance score were significantly lower in the cacao group compared to the placebo group after the treatment (p < 0.05). The change in the index of positive mood (i.e., vigor) from baseline to 8 weeks was significantly higher in the cacao group versus the placebo group (p < 0.05). There were no significant between-group differences in the changes in the CFS score or ANS activity level. The consumption of flavanol-rich cacao extract both suppressed negative moods and promoted positive moods in healthy middle-aged women. These results suggest that cacao flavanols may be a useful food material that can improve variable mood conditions in middle-aged women and support their active lives.
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3.
Depressive Symptoms in Middle-Aged and Elderly Women Are Associated with a Low Intake of Vitamin B6: A Cross-Sectional Study.
Odai, T, Terauchi, M, Suzuki, R, Kato, K, Hirose, A, Miyasaka, N
Nutrients. 2020;12(11)
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Depression and anxiety are common mental disorders, which are more prominent in women undergoing menopause. Large hormonal fluctuations are thought to be the driving factor, however treatments for this may have side effects such as heart disease and cancer. Interest in complementary therapies has increased and associations between several nutrients and mental health disorders has been reported, however their affects in perimenopausal and post-menopausal women is still unknown. This cross-sectional study of 289 women aged 40 and over aimed to look at associations between dietary nutrient consumption and anxiety/depressive symptoms. The results showed that over half of the women reported some symptoms of anxiety or depression. Of the 43 nutrients examined, only decreased vitamin B6 intake was associated with symptoms of moderate-severe depression but not symptoms of anxiety. It was concluded that moderate to severe depressive symptoms were associated with a lower dietary intake of vitamin B6. However, it should be noted that dietary intake and not serum levels were used to make associations. This study could be used by healthcare professionals to recommend increased dietary vitamin B6 intake for symptoms of moderate to severe depression in women aged 40 or over.
Abstract
This study investigated the nutritional factors that are associated with anxiety and depressive symptoms in Japanese middle-aged and elderly women. We conducted a cross-sectional study with 289 study participants aged ≥40 years (mean age = 52.0 ± 6.9 years). Their dietary habits, menopausal status and symptoms, and varied background factors, such as body composition, lifestyle factors, and cardiovascular parameters, were assessed. Their anxiety and depressive symptoms were evaluated using the Hospital Anxiety and Depression Scale (HADS), where scores of 0-7 points, 8-10 points, and 11-21 points on either the anxiety or depression subscales were categorized as mild, moderate, and severe, respectively. The dietary consumption of nutrients was assessed using a brief self-administered diet history questionnaire. The relationships between the moderate-to-severe anxiety/depressive symptoms and the dietary intake of 43 major nutrients were investigated using multivariate logistic regression analyses. After adjusting for age, menopausal status, and the background factors that were significantly related to depressive symptoms, moderate and severe depression was significantly inversely associated with only vitamin B6 (adjusted odds ratio per 10 μg/MJ in vitamin B6 intake = 0.89, 95% confidence interval = 0.80-0.99). A higher intake of vitamin B6 could help relieve depressive symptoms for this population.
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The Diverse Efficacy of Food-Derived Proanthocyanidins for Middle-Aged and Elderly Women.
Izumi, T, Terauchi, M
Nutrients. 2020;(12)
Abstract
Middle-aged and elderly women are affected by various symptoms and diseases induced by estrogen deficiency. Proanthocyanidins, widely present in many kinds of fruits and berries, have many beneficial effects, such as antioxidative, anti-inflammatory, and antimicrobial activities. We researched the effects of proanthocyanidins for middle-aged and elderly women, finding that it has been revealed in many clinical trials and cohort studies that proanthocyanidins contribute to the prevention of cardiovascular disease, hypertension, obesity, cancer, osteoporosis, and urinary tract infection, as well as the improvement of menopausal symptoms, renal function, and skin damage. Thus, proanthocyanidins can be considered one of the potent representatives of complementary alternative therapy.
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Effects of Chlorogenic Acids on Menopausal Symptoms in Healthy Women: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Trial.
Enokuchi, Y, Suzuki, A, Yamaguchi, T, Ochiai, R, Terauchi, M, Kataoka, K
Nutrients. 2020;(12)
Abstract
A reduction in estrogen levels in the perimenopausal and postmenopausal periods causes various symptoms in women, such as hot flushes, sweats, depression, anxiety, and insomnia. Chlorogenic acids (CGAs), which are phenolic compounds widely present in plants such as coffee beans, have various physiological functions. However, the effects of CGAs on menopausal symptoms are unknown. To examine the effects of CGAs on menopausal symptoms, especially hot flushes, a randomized, placebo-controlled, double-blind, parallel-group trial was conducted in healthy women. Eighty-two subjects were randomized and assigned to receive CGAs (270 mg) tablets or the placebo for 4 weeks. After 4 weeks of intake, the number of hot flushes, the severity of hot flushes during sleep, and the severity of daytime sweats decreased significantly in the CGA group compared to the placebo group. The modified Kupperman index for menopausal symptoms decreased significantly after 2 weeks in the CGA group compared to the placebo group. Adverse effects caused by CGAs were not observed. The results show that continuous intake of CGAs resulted in improvements in menopausal symptoms, especially hot flushes, in healthy women.
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6.
Effects of Grape Seed Proanthocyanidin Extract on Vascular Endothelial Function in Participants with Prehypertension: A Randomized, Double-Blind, Placebo-Controlled Study.
Odai, T, Terauchi, M, Kato, K, Hirose, A, Miyasaka, N
Nutrients. 2019;(12)
Abstract
This study aimed to investigate the effects of grape seed proanthocyanidin extract (GSPE) on blood pressure and vascular endothelial function in middle-aged Japanese adults with prehypertension. We conducted a randomized, double-blind, placebo-controlled study on 6 men and 24 women aged 40-64 years old. The participants were randomized to receive tablets containing either low-dose (200 mg/day) or high-dose (400 mg/day) GSPE, or placebo, for 12 weeks. Systolic and diastolic blood pressures (SBP and DBP, respectively), brachial flow-mediated dilation (FMD), and other cardiovascular parameters were measured before and after 4, 8, and 12 weeks of treatment. The mean SBP in the high-dose group significantly decreased by 13 mmHg after 12 weeks (P = 0.028), although FMD did not change. In an ad hoc analysis of non-smoking participants (n = 21), the mean SBP, DBP, stiffness parameter β, distensibility, incremental elastic modulus (Einc), and pulse wave velocity (PWV) also significantly improved in the high-dose group after 12 weeks. Changes in Einc and PWV from baseline to 12 weeks were significantly greater in the high-dose group than in the placebo group (Einc, P = 0.023; PWV, P = 0.03). GSPE consumption could help maintain vascular elasticity and normal blood pressure in this population.
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Efficacy of primary treatment with immunoglobulin plus ciclosporin for prevention of coronary artery abnormalities in patients with Kawasaki disease predicted to be at increased risk of non-response to intravenous immunoglobulin (KAICA): a randomised controlled, open-label, blinded-endpoints, phase 3 trial.
Hamada, H, Suzuki, H, Onouchi, Y, Ebata, R, Terai, M, Fuse, S, Okajima, Y, Kurotobi, S, Hirai, K, Soga, T, et al
Lancet (London, England). 2019;(10176):1128-1137
Abstract
BACKGROUND Genetic studies have indicated possible involvement of the upregulated calcium-nuclear factor of activated T cells pathway in the pathogenesis of Kawasaki disease. We aimed to assess safety and efficacy of ciclosporin, an immunosuppressant targeting this pathway, for protection of patients with Kawasaki disease against coronary artery abnormalities. METHODS We did a randomised, open-label, blinded endpoints trial involving 22 hospitals in Japan between May 29, 2014, and Dec 27, 2016. Eligible patients predicted to be at higher risk for intravenous immunoglobulin (IVIG) resistance were randomly assigned to IVIG plus ciclosporin (5 mg/kg per day for 5 days; study treatment) or IVIG (conventional treatment) groups, stratified by risk score, age, and sex. The primary endpoint was incidence of coronary artery abnormalities using Japanese criteria during the 12-week trial, assessed in participants who received at least one dose of study drug and who visited the study institution at least once during treatment. This trial is registered to Center for Clinical Trials, Japan Medical Association, number JMA-IIA00174. FINDINGS We enrolled 175 participants. One patient withdrew consent after enrolment and was excluded and one patient (in the study treatment group) was excluded from analysis because of lost echocardiography data. Incidence of coronary artery abnormalities was lower in the study treatment group than in the conventional treatment group (12 [14%] of 86 patients vs 27 [31%] of 87 patients; risk ratio 0·46; 95% CI 0·25-0·86; p=0·010). No difference was found in the incidence of adverse events between the groups (9% vs 7%; p=0·78). INTERPRETATION Combined primary therapy with IVIG and ciclosporin was safe and effective for favourable coronary artery outcomes in Kawasaki disease patients who were predicted to be unresponsive to IVIG. FUNDING Japan Agency for Medical Research and Development (grant CCT-B-2503).
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Safety and efficacy of intravenous ferric carboxymaltose in Japanese patients with iron-deficiency anemia caused by digestive diseases: an open-label, single-arm study.
Ikuta, K, Ito, H, Takahashi, K, Masaki, S, Terauchi, M, Suzuki, Y
International journal of hematology. 2019;(1):50-58
Abstract
Iron-deficiency anemia (IDA) accounts for majority of anemia. Although iron replacement therapy is effective, in Japan, conventional iron formulations have disadvantages such as gastrointestinal side effects for oral formulations and issues of frequent administration for intravenous (IV) formulations. Ferric carboxymaltose (FCM), which overcomes these limitations, is widely used as an IV iron source overseas. In this multi-center, open-label, single-arm study, we investigated the safety and efficacy of FCM up to 12 weeks after the start of administration in patients with IDA caused by digestive diseases. Thirty-nine patients diagnosed with IDA based on hemoglobin and serum ferritin levels were included. Eligible subjects were administered FCM until the total calculated iron dose (1000 or 1500 mg) was achieved over intervals of at least 1 week. A single iron dose was 500 mg. In the full analysis set (n = 39), the incidence of adverse events and adverse drug reactions was 71.8 and 48.7%, respectively. All events were as expected from the safety profile of IV iron. The mean change from baseline (10.39 g/dL) to the highest observed hemoglobin level was 3.31 g/dL. These results indicate the safety and efficacy of FCM for treating IDA caused by digestive diseases in Japanese patients.
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Effects of oral estradiol and levonorgestrel on cardiovascular risk markers in postmenopausal women.
Terauchi, M, Honjo, H, Mizunuma, H, Aso, T
Archives of gynecology and obstetrics. 2012;(6):1647-56
Abstract
PURPOSE This study aimed at investigating changes in postmenopausal women's cardiovascular risk markers induced by hormone therapy regimens of low (1.0 mg) or ultra-low (0.5 mg) doses of micronized estradiol (mE(2)) and levonorgestrel (LNG). METHODS Three randomized placebo-controlled trials were reanalyzed with regard to changes in cardiovascular risk markers, such as serum lipids, lipoproteins, and coagulation parameters. Trial 1 (n = 210) was an 8-week study comparing the effects of 1.0 or 0.5 mg of unopposed mE(2) on menopausal symptoms. Trial 2 (n = 194) was a 24-week study comparing the effects of 1.0 mg of mE(2) combined with 10, 20, or 40 μg of LNG on endometrial safety. Trial 3 (n = 195) was a 52-week study comparing the effects of 1.0 or 0.5 mg mE(2) + 40 μg LNG on bone metabolism. RESULTS 1.0 mg of unopposed mE(2) reduced low-density lipoprotein cholesterol (LDL-C) after as little as 8 weeks. 1.0 mg mE(2) for 24 weeks lowered the serum levels of total cholesterol (TC) and LDL-C, whereas the addition of LNG caused decreases in the levels of high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG) in a dose-dependent fashion. 1.0 or 0.5 mg mE(2) + 40 μg LNG for 52 weeks also lowered the levels of TC, HDL-C, LDL-C, and TG. Both regimens slightly lowered antithrombin and Protein C activities within normal limits. CONCLUSIONS Hormone therapy using 1.0 or 0.5 mg of mE(2) and LNG lowers the serum levels of TC, HDL-C, LDL-C, and TG without significantly affecting coagulation/fibrinolysis parameters.
