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

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

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Effects of Saccharomyces cerevisiae NK-1 on stool frequency and volume in healthy individuals with infrequent bowel movements: a randomized, placebo, placebo controlled, double-blind study

Functional Foods in Health and Disease ◽

10.31989/ffhd.v8i9.545 ◽

2018 ◽

Vol 8 (9) ◽

pp. 462

Author(s):

Ryuji Takeda ◽

Norio Kanesugi ◽

Michiyo Kanesugi ◽

Syukuko Ebihara ◽

Shigeru Imai

Keyword(s):

Saccharomyces Cerevisiae ◽

Adverse Events ◽

Bowel Movement ◽

Stool Frequency ◽

Double Blind Study ◽

Healthy Individuals ◽

Double Blind ◽

Test Food ◽

Gastrointestinal Discomfort ◽

Bowel Movements

Background: Constipation and other symptoms of gastrointestinal discomfort, such as abdominal swelling, are common among healthy individuals and have a significant impact on quality of life. Despite the known contribution of gut microbiomes to this pathology, little is known regarding which groups of microorganisms play a key role. Yeasts have been used for fermenting foods since ancient times. Saccharomyces cerevisiae is a type of yeast used for industrial and pharmaceutical purposes in the genetic and medical fields because it is unicellular with a simple biological structure. Yeast also helps improve the intestinal environment. The present study aimed to investigate the effect of foods containing Saccharomyces cerevisiae on bowel movement and to validate the safety of its long-term usage. Stool frequency and consistency were also assessed.Methods: This was a randomized, double-blind, parallel-group study. The test food contained S. cerevisiae NK-1 powder (1 × 1010 cells), whereas the placebo did not contain it. The food was made into sticks and provided to healthy individuals with infrequent bowel movements (3–5 movements a week), three times a day for 12 weeks. Then we investigated the changes in stool frequency, volume, and other adverse events. Results: The number of days with bowel movement significantly increased in the test group compared with the placebo group after 8–12 weeks of consuming the test food (p < 0.05). Based on the blood test results, there were no adverse events associated with the consumption of the test food observed.Conclusions: Consumption of the test food regulated intestinal function by promoting defecation in healthy individuals prone to constipation. Thus, S. cerevisiae NK-1 helps facilitate smoother defecation.Keywords: Saccharomyces cerevisiae NK-1, bowel movement, stool frequency volume, gastrointestinal discomfort

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Efficacy and Safety of Intravenous Acetylsalicylic Acid Lysinate Compared To Subcutaneous Sumatriptan and Parenteral Placebo in the Acute Treatment of Migraine. A Double-Blind, Double-Dummy, Randomized, Multicenter, Parallel Group Study

Cephalalgia ◽

10.1046/j.1468-2982.1999.019006581.x ◽

1999 ◽

Vol 19 (6) ◽

pp. 581-588 ◽

Cited By ~ 78

Keyword(s):

Adverse Events ◽

Acetylsalicylic Acid ◽

Rating Scale ◽

Double Blind ◽

Efficacy Analysis ◽

Parallel Group Study ◽

Parallel Group ◽

Significant Difference ◽

Lysine Acetylsalicylate ◽

Subcutaneous Sumatriptan

Two-hundred-and-seventy-eight patients with acute migraine attacks with or without aura were treated in 17 centers with 1.8 g lysine acetylsalicylate i.v. (Aspisol®;=1 g acetylsalicylic acid), 6 mg sumatriptan s.c. or placebo using a double-blind, double-dummy, randomized, multicenter parallel group study design. Two-hundred-and-seventy-five of them fulfilled the criteria for efficacy analysis, corresponding to 119 patients treated with lysine acetylsalicylate (L-ASA), 114 with sumatriptan and 42 with placebo injections. Both treatments were highly effective compared to placebo ( p <0.0001) in decreasing headache from severe or moderate to mild or none (verbal rating scale, VRS, placebo=23.8%). Sumatriptan showed a significantly ( p=0.001) better response (91.2%) compared to L-ASA (response 73.9%). Of the patients in the L-ASA-group, 43.7% were pain-free after 2 h; 76.3% after sumatriptan and 14.3% after placebo. It took patients on average 12.6 (L-ASA), 8.2 (sumatriptan), and 19.4 h (placebo) to be able to work again. There was no significant difference between treatment groups in recurrence of headache in responders within 24 h (18.2% L-ASA, 23.1% sumatriptan, 20% placebo). Accompanying symptoms (nausea, vomiting, photophobia, phonophobia, and visual disturbances) improved with both verum treatments to a similar extent. L-ASA was significantly better tolerated than sumatriptan (adverse events L-ASA 7.6%, sumatriptan 37.8%). In conclusion, subcutaneous sumatriptan and lysine acetylsalicylate i.v. are effective treatments for patients suffering from migraine attacks. Sumatriptan is more effective, but resulted in more adverse events.

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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

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfaa142.p0880 ◽

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<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<0.0001), low-density lipoprotein cholesterol (-0.94±0.72 vs. -0.04±0.58 mmol/L, P<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.

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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

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2012/803239 ◽

2012 ◽

Vol 2012 ◽

pp. 1-8 ◽

Cited By ~ 6

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.

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Effects of 4-week continuous ingestion of champignon extract on bowel movements and intestinal putrefaction products: a randomized, placebo-controlled, double-blinded, parallel-group comparative trial

Functional Foods in Health and Disease ◽

10.31989/ffhd.v8i5.517 ◽

2018 ◽

Vol 8 (5) ◽

pp. 280

Author(s):

Jun Nishihira ◽

Mie Nishimura ◽

Aiko Tanaka ◽

Hiroyo Kagami-katsuyma ◽

Akihiro Yamaguchi ◽

...

Keyword(s):

Placebo Group ◽

Bowel Movement ◽

Test Group ◽

Comparative Trial ◽

Parallel Group ◽

Significant Difference ◽

Bowel Movements ◽

Double Blinded ◽

Age Range ◽

Stool Volume

Background: The aim of this study was to analyze the putrefaction products in the feces of subjects from a previous study (age range 50–79 years) which assessed the improvement of breath, body, and fecal odor after ingesting champignon extract.Methods: The study was designed as a randomized, placebo-controlled, double-blinded, and parallel-group comparative trial. Subjects were divided into four groups, including the placebo (n=20), champignon extract at 50 mg/day (n=20), champignon extract at 500 mg/day (n=20), and champignon extract at 1000 mg/day (n=20) for 4 weeks.Results: The results revealed significant reduction in ammonia and p-cresol levels (both of which are intestinal putrefaction products) among subjects who ingested 50, 500, and 1000 mg of champignon extract per day compared with subjects in the placebo group. Additionally, a significant difference was observed in indole levels in the group that consumed 500 mg/day of the extract compared to the placebo group.Conclusions: The re-analysis of bowel movement in each test group revealed that the extract improved the number of days with bowel movement, number of bowel movements, and stool volume, which suggests the intestinal environment was improved.Clinical trial registration: UMIN000014256Keywords: ammonia, champignon, fecal odor, p-cresol, putrefaction

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Oral sumatriptan for migraine in children and adolescents: A randomized, multicenter, placebo-controlled, parallel group study

Cephalalgia ◽

10.1177/0333102413510213 ◽

2013 ◽

Vol 34 (5) ◽

pp. 365-375 ◽

Cited By ~ 14

Author(s):

Mitsue Fujita ◽

Katsuaki Sato ◽

Hiroshi Nishioka ◽

Fumihiko Sakai

Keyword(s):

Placebo Group ◽

Treatment Group ◽

Pain Relief ◽

Children And Adolescents ◽

Statistical Significance ◽

Complete Relief ◽

Post Dose ◽

Double Blind ◽

Parallel Group Study ◽

Parallel Group

Objective The objective of this article is to evaluate the efficacy and tolerability of two doses of oral sumatriptan vs placebo in the acute treatment of migraine in children and adolescents. Background Currently, there is no approved prescription medication in Japan for the treatment of migraine in children and adolescents. Methods This was a multicenter, outpatient, single-attack, double-blind, randomized, placebo-controlled, parallel-group study. Eligible patients were children and adolescents aged 10 to 17 years diagnosed with migraine with or without aura (ICHD-II criteria 1.1 or 1.2) from 17 centers. They were randomized to receive sumatriptan 25 mg, 50 mg or placebo (1:1:2). The primary efficacy endpoint was headache relief by two grades on a five-grade scale at two hours post-dose. Results A total of 178 patients from 17 centers in Japan were enrolled and randomized to an investigational product in double-blind fashion. Of these, 144 patients self-treated a single migraine attack, and all provided a post-dose efficacy assessment and completed the study. The percentage of patients in the full analysis set (FAS) population who report pain relief at two hours post-treatment for the primary endpoint was higher in the placebo group than in the pooled sumatriptan group (38.6% vs 31.1%, 95% CI: −23.02 to 8.04, p = 0.345). The percentage of patients in the FAS population who reported pain relief at four hours post-dose was higher in the pooled sumatriptan group (63.5%) than in the placebo group (51.4%) but failed to achieve statistical significance ( p = 0.142). At four hours post-dose, percentages of patients who were pain free or had complete relief of photophobia or phonophobia were numerically higher in the sumatriptan pooled group compared to placebo. Both doses of oral sumatriptan were well tolerated. No adverse events (AEs) were serious or led to study withdrawal. The most common AEs were somnolence in 6% (two patients) in the sumatriptan 25 mg treatment group and chest discomfort in 7% (three patients) in the sumatriptan 50 mg treatment group. Conclusions There was no statistically significant improvement between the sumatriptan pooled group and the placebo group for pain relief at two hours. Oral sumatriptan was well tolerated.

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Effect of Daily Ingestion of Quercetin-Rich Onion Powder for 12 Weeks on Visceral Fat: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study

Nutrients ◽

10.3390/nu12010091 ◽

2019 ◽

Vol 12 (1) ◽

pp. 91 ◽

Cited By ~ 1

Author(s):

Mie Nishimura ◽

Takato Muro ◽

Masuko Kobori ◽

Jun Nishihira

Keyword(s):

Placebo Group ◽

Visceral Fat ◽

Biological Activities ◽

Daily Intake ◽

Double Blind ◽

Visceral Fat Area ◽

Double Blind Placebo ◽

Parallel Group Study ◽

Parallel Group ◽

Computed Tomography Scanning

Quercetin, which is frequently found in vegetables such as onion, is widely found to have biological activities such as visceral fat reduction. Therefore, we performed this randomised double-blind placebo-controlled parallel-group study and analysed the effects of daily intake of quercetin-rich onion on visceral fat for 12 weeks. Seventy healthy Japanese subjects whose body mass index (BMI) was ≥23 and <30 were recruited and randomly assigned to either the quercetin-rich onion group or placebo group. The subjects ingested 9 g of onion powder per day for 12 weeks. We conducted medical interviews, hematological and biological tests; measured body composition and vital signs; and analysed the Food Frequency Questionnaire weeks 0, 4, 8, and 12. Abdominal fat area was measured using computed tomography scanning at weeks 0 and 12. No significant differences in visceral fat area (VFA) were observed between the two groups. However, in subjects whose high-density lipoprotein cholesterol was lower, VFA was significantly lower in the quercetin-rich onion group. In addition, alanine aminotransferase was significantly lower in the quercetin-rich onion group than in the placebo group. Thus, the results suggest that quercetin-rich onion may be beneficial for preventing obesity and improving liver function.

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Effects of Ingesting Fucoidan Derived from Cladosiphon okamuranus Tokida on Human NK Cells: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Pilot Study

Marine Drugs ◽

10.3390/md19060340 ◽

2021 ◽

Vol 19 (6) ◽

pp. 340

Author(s):

Makoto Tomori ◽

Takeaki Nagamine ◽

Tomofumi Miyamoto ◽

Masahiko Iha

Keyword(s):

Placebo Group ◽

Pilot Study ◽

Adverse Events ◽

Nk Cell ◽

Cell Activity ◽

Nk Cell Activity ◽

Double Blind ◽

Immunological Tests ◽

Parallel Group ◽

Cladosiphon Okamuranus

The aim of this study was to evaluate the effects of ingesting fucoidan derived from Okinawa mozuku (Cladosiphon okamuranus) on natural killer (NK) cell activity and to assess its safety in healthy adults via a randomized, double-blind, parallel-group, placebo-controlled pilot study. Subjects were randomly divided into two groups—a placebo group (ingesting citric acid, sucralose, and caramel beverages; n = 20; 45.5 ± 7.8 years (mean ± standard deviation)) and a fucoidan group (3.0 g/day from beverages; n = 20; 47.0 ± 7.6 years); after 12 weeks, blood, biochemical, and immunological tests were performed. Clinically adverse events were not observed in any of the tests during the study period. In addition, adverse events due to the test food were not observed. In the immunological tests, NK cell activity was significantly enhanced at 8 weeks in the fucoidan group, compared to before ingestion (0 weeks). In addition, a significantly enhanced NK cell activity was observed in male subjects at 8 weeks, compared with the placebo group. These results confirm that Okinawa mozuku-derived fucoidan enhances NK cell activity and suggest that it is a safe food material.

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