scholarly journals Intake of Koji Amazake Improves Defecation Frequency in Healthy Adults

2021 ◽  
Vol 7 (9) ◽  
pp. 782
Author(s):  
Atsushi Kurahashi ◽  
Toshihiko Enomoto ◽  
Yoshifumi Oguro ◽  
Ayana Kojima-Nakamura ◽  
Kazuya Kodaira ◽  
...  
Keyword(s):  
Placebo Group ◽  
Aspergillus Oryzae ◽  
Relative Abundance ◽  
Mechanism Of Action ◽  
Comparative Trial ◽  
Double Blind ◽  
Functional Ingredients ◽  
Fecal Weight ◽  
Parallel Group ◽  
Defecation Frequency

Reportedly, the intake of koji amazake, a beverage made from steamed rice fermented by Aspergillus oryzae, improves defecation frequency. However, its functional ingredients and mechanism of action remain unclear. To compare the effects of koji amazake and a placebo beverage on defecation frequency and to identify the functional ingredients and mechanism of action, a randomized, placebo-controlled, double-blind parallel-group comparative trial was performed on two groups. The Koji amazake had 302 ± 15.5 mg/118 g of A. oryzae cells, which was not in the placebo. Compared with the placebo group, the koji amazake group showed a significant increase in weekly defecation frequency at 2 weeks (5.09 days vs. 4.14 days), 3 weeks (5.41 days vs. 4.18 days), and 4 weeks (5.09 days vs. 3.95 days), along with an increase in the weekly fecal weight at 4 weeks (724 g vs. 501 g). The intake of koji amazake did not induce significant intergroup differences in the fecal SCFA concentration, whereas it significantly decreased the relative abundance of Blautia and significantly increased that of Bacteroides at 3 weeks. Therefore, koji amazake intake improved defecation frequency, and A. oryzae cells played potentially important roles as functional ingredients.

scholarly journals Effect of 12-Week Daily Intake of the High-Lycopene Tomato (Solanum Lycopersicum), a Variety Named “PR-7”, on Lipid Metabolism: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study

Nutrients ◽  
2019 ◽  
Vol 11 (5) ◽  
pp. 1177 ◽  
Author(s):  
Mie Nishimura ◽  
Naoki Tominaga ◽  
Yuko Ishikawa-Takano ◽  
Mari Maeda-Yamamoto ◽  
Jun Nishihira
Keyword(s):  
Placebo Group ◽  
Lipid Metabolism ◽  
Solanum Lycopersicum ◽  
Biological Effects ◽  
Daily Intake ◽  
Vital Signs ◽  
Density Lipoprotein ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Parallel Group

Tomato (Solanum lycopersicum) is a rich source of lycopene, a carotenoid that confers various positive biological effects such as improved lipid metabolism. Here, we conducted a randomized, double-blind, placebo-controlled, parallel-group comparative study to investigate the effects of regular and continuous intake of a new high-lycopene tomato, a variety named PR-7, for 12 weeks, based on 74 healthy Japanese subjects with low-density lipoprotein cholesterol (LDL-C) levels ≥120 to <160 mg/dL. The subjects were randomly assigned to either the high-lycopene tomato or placebo (lycopene-free tomato) group. Each subject in the high-lycopene group ingested 50 g of semidried PR-7 (lycopene, 22.0–27.8 mg/day) each day for 12 weeks, while subjects in the placebo group ingested placebo semidried tomato. Medical interviews were conducted, vital signs were monitored, body composition was determined, and blood and saliva samples were taken at weeks 0 (baseline), 4, 8, and 12. The primary outcome assessed was LDL-C. The intake of high-lycopene tomato increased lycopene levels in this group compared to levels in the placebo group (p < 0.001). In addition, high-lycopene tomato intake improved LDL-C (p = 0.027). The intake of high-lycopene tomato, PR-7, reduced LDL-C and was confirmed to be safe.

scholarly journals Testosterone Patch Increases Sexual Activity and Desire in Surgically Menopausal Women with Hypoactive Sexual Desire Disorder

2005 ◽  
Vol 90 (9) ◽  
pp. 5226-5233 ◽  
Author(s):  
James Simon ◽  
Glenn Braunstein ◽  
Lila Nachtigall ◽  
Wulf Utian ◽  
Molly Katz ◽  
...  
Keyword(s):  
Placebo Group ◽  
Sexual Activity ◽  
Sexual Desire ◽  
Estrogen Therapy ◽  
Hypoactive Sexual Desire Disorder ◽  
Double Blind ◽  
End Points ◽  
Parallel Group ◽  
Menopausal Women ◽  
Desire Disorder

Abstract Context: Hypoactive sexual desire disorder (HSDD) is one of the most common sexual problems reported by women, but few studies have been conducted to evaluate treatments for this condition. Objective: The objective of this study was to evaluate the efficacy and safety of a testosterone patch in surgically menopausal women with HSDD. Design: The design was a randomized, double-blind, parallel-group, placebo-controlled, 24-wk study (the Intimate SM 1 study). Setting: The study was performed at private or institutional practices. Patients: The subjects studied were women, aged 26–70 yr, with HSDD after bilateral salpingo-oophorectomy who were receiving concomitant estrogen therapy. Placebo (n = 279) or testosterone 300 μg/d (n = 283) was administered. There were 19 patients who withdrew due to adverse events in the placebo group and 24 in the 300 μg/d testosterone group. Intervention: Testosterone (300 μg/d) or placebo patches were applied twice weekly. Main Outcome Measure(s): The primary end point was the change in the frequency of total satisfying sexual activity at 24 wk. Secondary end points included other sexual functioning end points and safety assessments. Results: At 24 wk, there was an increase from baseline in the frequency of total satisfying sexual activity of 2.10 episodes/4 wk in the testosterone group, which was significantly greater than the change of 0.98 episodes/4 wk in the placebo group (P = 0.0003). The testosterone group also experienced statistically significant improvements in sexual desire and a decrease in distress. The overall safety profile was similar in both treatment groups. Conclusion: In the Intimate SM 1 study, the testosterone patch improved sexual function and decreased distress in surgically menopausal women with HSDD and was well tolerated in this trial.

scholarly journals Improvement of defecation in healthy individuals with infrequent bowel movements through the ingestion of dried Mozuku powder: a randomized, double-blind, parallel-group study

2017 ◽  
Vol 7 (9) ◽  
pp. 735
Author(s):  
Masaki Matayoshi ◽  
Junjiro Teruya ◽  
Mina Yasumoto-Hirose ◽  
Ryuji Teruya ◽  
Naoki Miura ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Bowel Movement ◽  
Intestinal Function ◽  
Healthy Individuals ◽  
Double Blind ◽  
Blood Tests ◽  
Parallel Group Study ◽  
Parallel Group ◽  
Bowel Movements

Background: Okinawa mozuku (Cladosiphon okamuranu) is a type of edible seaweed of the family Chordariaceae that typically contains the polysaccharide fucoidan as a functional ingredient. In Okinawa, raw mozuku is eaten as vinegared mozuku together with vinegar or as tempura (deep-fried in batter). Polysaccharides such as fucoidan are generally known to regulate intestinal function, which is why we have used Okinawa mozuku to investigate this intestinal regulatory effect.Methods: The study was designed as a randomized, double-blind, parallel group study. Dried Okinawa mozuku powder at a dose of 2.4 g/day (1.0 g/day of fucoidan) and a placebo not containing any dried Okinawa mozuku powder were each made into capsules and given to healthy men and women with infrequent weekly bowel movements (2–4 movements a week) to ingest for eight weeks. We then investigated changes in the defecation situation, blood tests, and adverse events. Results: In the group that ingested the capsules containing dried Okinawa mozuku powder, the number of days with a bowel movement significantly increased compared with the placebo group after four weeks of ingestion (p < 0.05). Furthermore, after eight weeks of ingestion, the same increasing trend was seen compared with the placebo group (p = 0.0964). The volume of stool also increased significantly in the dried Okinawa mozuku powder group after eight weeks compared with the placebo group. In terms of blood tests and adverse events, no adverse events occurred that were the result of the test food.Conclusions: Ingestion of Okinawa mozuku was found to have a regulatory effect on intestinal function by promoting defecation in healthy individuals with a tendency for constipation. This demonstrated that Okinawa mozuku is a functional food capable of making defecation smoother and increasing the volume of stool.Key Words: Okinawa mozuku, Cladosiphon okamuranus, fucoidan, dry powder, bowel movement, constipation

A randomized, double-blind study of alpidem vs placebo in the prevention and treatment of benzodiazepine withdrawal syndrome

1996 ◽  
Vol 11 (2) ◽  
pp. 93-99 ◽  
Author(s):  
GB Cassano ◽  
A Petracca ◽  
C Borghi ◽  
S Chiroli ◽  
G Didoni ◽  
...  
Keyword(s):  
Placebo Group ◽  
Withdrawal Syndrome ◽  
Adjustment Disorder ◽  
Generalized Anxiety ◽  
Double Blind Study ◽  
Double Blind ◽  
Treatment Allocation ◽  
Parallel Group ◽  
Benzodiazepine Withdrawal ◽  
One Year

SummaryThe aim of the trial was to assess alpidem efficacy in preventing and treating the benzodiazepine (BZ) withdrawal syndrome (WS). A multicentre, double-blind, randomized versus placebo, parallel group study of six-week duration was carried out in outpatients suffering from generalized anxiety or adjustment disorder with an anxious mood and taking non-hypnotic BZ as continuous course of therapy of at least one-year duration. At the entry, the patients abruptly discontinued BZs and were treated with 50 mg/bid/tid of alpidem or placebo. Withdrawal syndrome diagnosis was (regarding treatment allocation) formulated by an independent psychiatrist, according to DSM-III-R and an appropriate scale, the SESSB. One hundred seventy-three patients were randomized and 148 completed the study. Withdrawal syndrome occurred in 27 patients of the alpidem group (31.0%) and in 38 patients of the placebo group (44.2%). A severe WS was diagnosed in 11.1% of the patients in the alpidem group and in 31.6% of the placebo group. If not having been withdrawn from the market, alpidem could have been useful for the prevention of BZ withdrawal syndrome.

Naproxen Sodium in the Treatment of Migraine

Cephalalgia ◽  
1985 ◽  
Vol 5 (1) ◽  
pp. 5-10 ◽  
Author(s):  
ES Johnson ◽  
DM Ratcliffe ◽  
M Wilkinson
Keyword(s):  
Placebo Group ◽  
Rescue Medication ◽  
Naproxen Sodium ◽  
Double Blind ◽  
Treatment Groups ◽  
Parallel Group ◽  
Significant Difference ◽  
Previous Visit ◽  
Premonitory Symptoms ◽  
Visual Disturbances

Seventy patients with classical or common migraine were treated during their attacks with either naproxen sodium or placebo in a randomised, double-blind parallel group study. The initial dose of naproxen sodium was 825 mg followed one hour later by a further 550 mg, if symptoms were the same or had improved. If the migraine symptoms had worsened, patients were offered an escape analgesic combination of 1000 mg paracetamol and 10 mg metoclopramide. Patients were assessed at monthly intervals for changes in the severity and duration of headache, premonitory symptoms (mainly visual disturbances) and photophobia, nausea and vomiting associated with migraine attacks that had occurred since the previous visit. Patients were studied for a maximum of ten attacks and significant improvement was observed in the severity and duration of headache when the patients were on naproxen sodium. Also the premonitory symptoms and photophobia improved significantly on naproxen sodium and significantly less rescue analgesics were required. Patients suffering from common migraine had less severe headaches and photophobia when taking naproxen sodium than when taking placebo and the headaches were shorter in duration and patients took less rescue analgesic. No significant difference was observed between the treatment groups in patients with classical migraine. Ten patients in the placebo group and six in the naproxen sodium group reported side-effects but these were possibly related to the use of rescue medication. Naproxen sodium proved safe and effective in common migraine attacks, but in this study efficacy was not established for classical migraine.

P0880EFFICACY AND SAFETY OF SEVELAMER CARBONATE IN NON-DIALYSIS HYPERPHOSPHATEMIA PATIENTS: A RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP STUDY FOR THE TREATMENT OF HYPERPHOSPHATEMIA IN PATIENTS WITH CHRONIC KIDNEY DISEASE NOT ON DIALYSIS IN CHINA

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Xueqing Yu
Keyword(s):  
Chronic Kidney Disease ◽  
Placebo Group ◽  
Kidney Disease ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Parallel Group Study ◽  
Parallel Group ◽  
Sevelamer Carbonate ◽  
The Mean

Abstract Background and Aims Hyperphosphatemia in chronic kidney disease (CKD) patients is associated with adverse outcomes, including vascular calcification, increasing risks of disease progression and even death. Sevelamer carbonate have been approved in Europe for phosphate lowering treatment in pre-dialysis CKD patient, its efficacy and safety in Chinese CKD hyperphosphatemia patients are not previously reported. Method This was a phase III, multi-center, randomized, double blind, placebo-controlled, balanced (1:1, sevelamer: placebo) parallel-group study to evaluate the efficacy and safety of sevelamer carbonate versus placebo over 8 weeks’ duration in hyperphosphatemic CKD patients not on dialysis in China (Registration number NCT03001011). The primary objective of this study is to demonstrate efficacy of sevelamer carbonate tablets in the reduction of serum phosphorus in hyperphosphatemia in patients with chronic kidney disease (CKD) not on dialysis. Results In all, 202 patients were randomized (sevelamer, n=101; placebo, n=101); mean age was 50.7 years, 53.5% were male and the mean time of CKD diagnosis was 3.4 years with mean eGFR 7.5 ml/min/1.73 m2. The baseline phosphorous were 2.13±0.35 mmol/L and 2.12±0.37 mmol/L in sevelamer and placebo group, respectively. The mean serum phosphorous decreased significantly in patients treated with sevelamer carbonate (-0.22±0.47 mmol/L) compared with placebo (0.05±0.44 mmol/L) (mean difference between sevelamer carbonate and placebo was -0.26 mmol/L, P&lt;0.0001). When compared with placebo, sevelamer carbonate significantly reduced serum total cholesterol (-0.90±0.85 vs. -0.06±0.68 mmol/L, P&lt;0.0001), low-density lipoprotein cholesterol (-0.94±0.72 vs. -0.04±0.58 mmol/L, P&lt;0.0001) and calcium-phosphorous product (-0.48±0.97 vs. 0.05±0.81 mmol2/L2) from baseline to week 8. Serum iPTH was not significantly changed in sevelamer carbonate group compared with placebo group (-9.60±136.00 vs. 7.61±141.92 ng/L, P=0.83). Sevelamer carbonate was well tolerated with 83.27% compliance compared with 82.19% compliance in placebo arm. Average dose of sevelamer carbonate was 7.51 g/d at the end of study and 4.52 g/d across the study. Adverse events experienced by patients in sevelamer carbonate and placebo group were similar. Conclusion This study demonstrated that sevelamer carbonate has produced a significant reduction of serum phosphorous, and is safe and tolerated in Chinese pre-dialysis CKD patients with hyperphosphatemia.

scholarly journals Effects of Chlorogenic Acids on Menopausal Symptoms in Healthy Women: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Trial

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3757
Author(s):  
Yuka Enokuchi ◽  
Atsushi Suzuki ◽  
Tohru Yamaguchi ◽  
Ryuji Ochiai ◽  
Masakazu Terauchi ◽  
...  
Keyword(s):  
Placebo Group ◽  
Menopausal Symptoms ◽  
Hot Flushes ◽  
Chlorogenic Acids ◽  
Double Blind ◽  
Healthy Women ◽  
Kupperman Index ◽  
Parallel Group ◽  
Parallel Group Trial ◽  
Group Trial

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.

scholarly journals Safety and Efficacy of Tien-Hsien Liquid Practical in Patients with Refractory Metastatic Breast Cancer: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase IIa Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Wen-Hung Kuo ◽  
Chien-An Yao ◽  
Chih Hui Lin ◽  
King-Jen Chang
Keyword(s):  
Breast Cancer ◽  
Placebo Group ◽  
Metastatic Breast Cancer ◽  
Adverse Events ◽  
Pilot Trial ◽  
Metastatic Breast ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Double Blind Placebo ◽  
Parallel Group

To evaluate the safety and efficacy of Tien-Hsien Liquid Practical (THL-P), a Chinese herbal mixture, in patients with refractory metastatic breast cancer, we performed a randomized, double-blind, placebo-controlled, parallel-group, phase IIa pilot trial. Patients were randomly assigned to either receive THL-P or matching placebo and followed up every 4 weeks for 24 weeks. The primary endpoint was changes in the global health status/quality of life (GHS/QOL) scale. The secondary endpoints were changes in functional and symptom scales, immunomodulating effects, and adverse events. Sixty-three patients were enrolled between June 2009 and June 2011. The intent-to-treat population included 28 patients in the THL-P group and 11 patients in the placebo group. Compared to the placebo group, the THL-P group had significant improvement from baseline to last visit in GHS/QOL (41.7 versus −33.3;P<0.05), CD3, CD4/CD8, CD19, CD16+56 positive cells (P<0.05), and higher levels of physical, role, emotional, and cognitive functioning, as well as decreased fatigue and systemic side effects. Treatment-related adverse events were mild constipation and localized itching, and no serious adverse events were reported. THL-P appears to be a safe alternative adjuvant treatment for patients with refractory metastatic breast cancer, as it effectively improves QOL and palliates cancer-related symptoms.

Sign in / Sign up

Export Citation Format

Share Document