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 Effects of daily intake of Harudori-kombu: A randomized, double-blind, placebo-controlled, parallel-group study

2019 ◽  
Vol 9 (4) ◽  
pp. 205
Author(s):  
Mie Nishimura ◽  
Miwako Sugawara ◽  
Masafumi Kudo ◽  
Yasunori Kinoshita ◽  
Hiroyuki Yoshino ◽  
...  
Keyword(s):  
Body Fat ◽  
Low Density Lipoprotein ◽  
Daily Intake ◽  
Density Lipoprotein ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Parallel Group Study ◽  
Parallel Group ◽  
Medical Interviews ◽  
Functional Components

Background: Kombu (Laminariaceae) is traditionally consumed in Japan. “Harudori-kombu” is young kombu harvested in spring. Harudori-kombu contains functional components, such as fucoxanthin—a carotenoid—which confer various biological effects.Methods: In this study, we investigated effects of the continuous intake of dried Harudori-kombu (2.0 g/day) for 6 weeks. We conducted a randomized, double-blind, placebo-controlled, parallel-group study including 70 healthy Japanese subjects with body mass index between 22 and 30 kg/m2 and low-density lipoprotein cholesterol levels between 120 and 160 mg/dL. Subjects were randomly assigned to either Harudori-kombu group or placebo group. Subjects ingested 9 capsules per day for 6 weeks. We conducted medical interviews, vital sign examinations, and blood sampling at weeks 0 (baseline), 2, and 6. Moreover, we assessed body composition at weeks 0 and 6.Results: Harudori-kombu intake did not improve the lipid profile but did reduce body fat. In addition, adiponectin levels were significantly improved.Conclusions: Harudori-kombu intake showed beneficial health effects, such as reduction in body fat and improvement of adiponectin levels, and was deemed safe at the dose administered in this study.

scholarly journals 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 ◽  
2019 ◽  
Vol 12 (1) ◽  
pp. 91 ◽  
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.

scholarly journals Daily intake of heat-killed Lactobacillus plantarum L-137 improves inflammation and lipid metabolism in overweight healthy adults: a randomized-controlled trial

2019 ◽  
Vol 59 (6) ◽  
pp. 2641-2649 ◽  
Author(s):  
Yusuke Tanaka ◽  
Yoshitaka Hirose ◽  
Yoshihiro Yamamoto ◽  
Yasunobu Yoshikai ◽  
Shinji Murosaki
Keyword(s):  
Lipid Metabolism ◽  
Lactobacillus Plantarum ◽  
Mononuclear Cells ◽  
Controlled Trial ◽  
Low Density Lipoprotein ◽  
Daily Intake ◽  
Density Lipoprotein ◽  
Control Group ◽  
Double Blind ◽  
Peripheral Blood Mononuclear

Abstract Purpose The effects of heat-killed Lactobacillus plantarum L-137 (HK L-137) on inflammation and lipid metabolism were investigated in overweight volunteers. Methods One hundred healthy subjects with a body mass index from 23.0 to 29.9 (51 men and 49 women; mean age: 41.4 years) were enrolled in this randomized, double-blind, placebo-controlled, parallel group study. Subjects were randomly assigned to daily administration of a tablet containing HK L-137 (10 mg) or a placebo tablet for 12 weeks. Blood samples were collected every 4 weeks to measure biomarkers of lipid metabolism and inflammatory mediators. Results The percent change of concanavalin A-induced proliferation of peripheral blood mononuclear cells was significantly larger in the HK L-137 group than in the control group, similar to previous studies. The decreases of aspartate aminotransferase and alanine aminotransferase over time were significantly larger in the HK L-137 group than in the control group, as were the decreases of total cholesterol, low-density lipoprotein cholesterol, and the leukocyte count at one time point. These effects of HK L-137 were stronger in the subjects with higher C-reactive protein levels. Conclusions These findings suggest that daily intake of HK L-137 can improve inflammation and lipid metabolism in subjects at risk of inflammation.

scholarly journals Effect of Daily Intake of Heat-Killed Lactobacillus plantarum HOKKAIDO on Immunocompetence: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study

2020 ◽  
Vol 3 (3) ◽  
pp. 32
Author(s):  
Jun Nishihira ◽  
Akane Haseda ◽  
Mie Nishimura ◽  
Miwako Sugawara ◽  
Masafumi Kudo ◽  
...  
Keyword(s):  
Lactobacillus Plantarum ◽  
Common Cold ◽  
Healthy Subjects ◽  
Nk Cell ◽  
Daily Intake ◽  
Cell Activity ◽  
Nk Cell Activity ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Parallel Group

Background: Consumption of Lactobacillus plantarum HOKKAIDO (HOKKAIDO strain) reportedly increases immunocompetence. However, the concentration of viable bacteria and the type of food they can be incorporated into limits their consumption. The study aims to demonstrate the effect of daily intake of the heat-killed L. plantarum HOKKAIDO strain (HK-HOKKAIDO strain; 5 × 1010 colony-forming units/day) by healthy subjects with low natural killer (NK) cell activity for 8 weeks.Method: In this randomized, double-blind, placebo-controlled, parallel-group study, 70 healthy Japanese subjects who showed relatively low NK cell activity were recruited and randomly assigned to the HK-HOKKAIDO strain or placebo group. All subjects ingested one capsule per day for 8 weeks. We conducted medical interviews and performed body composition measurements, vital sign examinations, and blood sampling at weeks 0 (baseline), 4, and 8, and we collected salivary samples at weeks 0 and 8. In addition, the frequency and severity of cold symptoms in the subjects were recorded daily during the intake period.Results: Intake of the HK-HOKKAIDO strain did not increase the NK cell activity or immunity marker levels, including those of immunoglobulin, leukocyte fraction, and salivary secretory immunoglobulin A. However, the frequency and severity of the common cold symptoms were significantly reduced after the daily consumption of the HK-HOKKAIDO strain.Conclusions: The results showed that HK-HOKKAIDO strain administration can decrease the frequency and severity of common cold symptoms in healthy subjects. Our findings support the use of the HK-HOKKAIDO strain as a functional food with health benefits.Clinical trial registration: UMIN000034822 

scholarly journals A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Assessing the Effects of Angelica Gigas Nakai Extract on Blood Triglycerides

Nutrients ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 377
Author(s):  
Su-Jin Jung ◽  
Woo-Rim Kim ◽  
Mi-Ra Oh ◽  
Youn-Soo Cha ◽  
Byung-Hyun Park ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Density Lipoprotein ◽  
Atherogenic Index ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Angelica Gigas ◽  
Double Blind Placebo ◽  
Angelica Gigas Nakai

Angelica gigas Nakai, Korean dang-gui, has long been widely used in traditional treatment methods. There have been a number of studies of the health effects of A. gigas and related compounds, but studies addressing effects on blood triglycerides (TG) are lacking. To investigate the effects of A. gigas Nakai extract (AGNE) on TG in Korean subjects, we carried out a 12-week, randomized, double-blind, placebo-controlled clinical trial. Subjects who met the inclusion criterion (130 mg/dL ≤ fasting blood TG ≤ 200 mg/dL) were recruited for this study. One hundred subjects were assigned to the AGNE group (n = 50) or the placebo group (n = 50), who were given 1 g/day of AGNE (as a gigas Nakai extract 200 mg/d) in capsules and the control group for 12 weeks. Outcomes were efficacy TG, lipid profiles, atherogenic index, and safety parameters were assessed initially for a baseline measurement and after 12 weeks. After 12 weeks of supplementation, TG and very low-density lipoprotein cholesterol (VLDL-C) concentration and TG/HDL-C ratio in the AGNE group were significantly reduced compared to the placebo group (p < 05). No significant changes in any safety parameter were observed. These results suggest that the ingestion of AGNE may improve TG and be useful to manage or prevent hypertriglyceridemia.

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.

scholarly journals Efficacy and safety of Kami-guibi-tang for mild cognitive impairment: a pilot, randomized, double-blind, placebo-controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hee-Yeon Shin ◽  
Ha-Ri Kim ◽  
Geon-Ho Jahng ◽  
Chul Jin ◽  
Seungwon Kwon ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Placebo Group ◽  
Mild Cognitive Impairment ◽  
Adverse Events ◽  
Vital Signs ◽  
Efficacy And Safety ◽  
Mri Findings ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

Abstract Background Mild cognitive impairment (MCI) is considered an intermediate phase between normal aging and dementia. As the majority of cases of amnestic MCI (aMCI) progress to Alzheimer’s disease (AD), it is considered the prodromal stage of AD, and a treatment target for prevention of further cognitive decline. However, no medications have been shown to have symptomatic or preventive benefits in MCI. Kami-guibi-tang (KGT) is a traditional herbal formula used in Korean medicine to treat amnesia, which is reported to increase acetylcholine levels via activation of choline acetyltransferase. The objective of this study was to evaluate the efficacy and safety of KGT in patients with aMCI. Methods This study was designed as a single-center, randomized, double-blind, placebo-controlled pilot study. Participants diagnosed with aMCI were randomized to receive either KGT or placebo granules for 24 weeks. The efficacy measure was a change in the Seoul Neuropsychological Screening Battery (SNSB) score. The safety measures included the occurrence of adverse events and abnormalities in vital signs and blood chemistry, electrocardiogram (ECG), and brain magnetic resonance imaging (MRI) findings. Results A total of 16 patients in the KGT group and 14 patients in the placebo group were investigated in the study. The mean score of Clinical Dementia Rating-Sum of Boxes (CDR-SB) significantly improved from 1.53 (0.64) points to 1.13 (0.62) points in the KGT group (p = 0.010), whereas it worsened from 1.61 (0.88) points to 1.75 (0.94) points in the placebo group. There was a significant difference in the CDR-SB scores between the two groups after the intervention (p = 0.045). The total SNSB-D scores and the scores in the memory domain after the treatment were significantly higher than the baseline values in the KGT group, but not in the placebo group. The frequency of adverse events was not significantly different between the two groups, and there were no abnormalities in vital signs or blood test, ECG, and brain MRI findings after the intervention. Conclusions KGT may provide a safe and effective treatment option for patients with aMCI. Further studies with a larger sample size are needed to validate the findings. Trial registration Korean Clinical Trial Registry, ID: KCT0002407; Registered on March 30, 2017, http://cris.nih.go.kr/

scholarly journals Zhizhu Kuanzhong Capsule in Treating Patients With Functional Dyspepsia Postprandial Distress Syndrome: Study Protocol For a Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Group Clinical Trial

2021 ◽  
Author(s):  
Mengli Xiao ◽  
Linda LD Zhong ◽  
Wai Ching Lam ◽  
Yingpan Zhao ◽  
Kok-Ann Gwee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Functional Dyspepsia ◽  
Distress Syndrome ◽  
Functional Gastrointestinal Disorders ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Postprandial Distress Syndrome ◽  
Parallel Group

Abstract Background: Functional dyspepsia (FD) is one of the most common functional gastrointestinal disorders. Based on the various symptoms present in patients with functional dyspepsia-postprandial distress syndrome (FD-PDS), routine agents such as acid suppressants, prokinetic drugs, and centrally acting drugs, offer limited treatment choice with potential side effects. As preliminary clinical trial showed that the marketed product Zhizhu Kuanzhong Capsule (ZZKZ) can improve symptoms in FD-PDS patients, our study aims to provide further evidence on the clinical efficacy and safety of ZZKZ in the treatment of patients with FD-PDS. Methods: In this multicenter, randomized, double-blind, placebo-controlled, parallel group clinical trial, we recruit patients with FD-PDS from 18 hospitals in China and Australia. The trial enrolls patients with FD-PDS based on the Rome IV diagnostic criteria. A total of 480 eligible patients are randomized 1:1 into either ZZKZ or placebo group with 8 weeks of treatment and 4 weeks of follow-up. The primary endpoint is measured by self-rated Visual Analogue Score (VAS) for the degree of discomfort with both symptoms of postprandial fullness and early satiation, recorded once a day and 7 days a week. The primary analysis aims to compare the response rate for FD-PDS VAS score between the groups before and after 8 weeks of treatment with an alpha level of 0.05 (2-sided).Discussion: This trial aims to strengthen the evidence for the efficacy and safety of ZZKZ, a marketed product, in treating FD-PDS. Compared to previous clinical trial targeted FD-PDS, this trial has 8-week double-blind treatment period to investigate the effect of long-term mediation through comparison with the placebo group.Trial registration: This study is registered with ClinicalTrials.gov on 28 January 2019, number NCT03825692.

scholarly journals Intake safety of Lactobacillus helveticus SBT2171 and its effects on nasal and ocular symptoms associated with mites and house dust: An open-label study and a randomized, double-blind, placebo-controlled, parallel group study

2019 ◽  
Vol 9 (1) ◽  
pp. 52 ◽  
Author(s):  
Maya Yamashita ◽  
Eiji Kobatake ◽  
Shun Obuchi ◽  
Masayuki Iwai ◽  
Kazuyuki Ichikawa ◽  
...  
Keyword(s):  
House Dust ◽  
Daily Intake ◽  
Lactobacillus Helveticus ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Double Blind Placebo ◽  
Ocular Symptoms ◽  
Parallel Group

Background: We previously reported that Lactobacillus helveticus SBT2171 (LH2171) inhibited the proliferation and secretion of lipopolysaccharide-stimulated inflammatory cytokines in primary immune cells. Furthermore, in vivo administration of LH2171 has been demonstrated to suppress the incidence and development of murine rheumatoid arthritis. In this study, we evaluated whether the intake of drinkable yogurt (DY) containing LH2171 alleviated nasal and ocular symptoms of allergy to mites and house dust allergens. The safety of LH2171 was also confirmed in an independent, open-label study in 20 healthy subjects who consumed an excessive amount of LH2171.Methods: In study 1, the effect of daily intake of DY containing LH2171 for 12 weeks on nasal and ocular symptoms was evaluated in healthy men and women who tested positive for house dust or mite-specific IgE in a randomized, double-blind, placebo-controlled, parallel group study. One hundred subjects were divided into two groups: subjects taking placebo DY (P group, n = 50) and subjects taking DY containing approximately 1 × 109 cells of LH2171 (LH2171 group, n = 50) daily for the 12 weeks. After excluding subjects that met exclusion criteria, data obtained from 94 subjects (LH2171 group: n = 48; P group: n = 46) were analyzed to establish LH2171 efficacy. LH2171 safety was assessed in an independent, open-label trial in 20 subjects (study 2) who consumed an excessive amount of DY containing approximately 3 × 109 LH2171 cells.Results: In study 1, the decreases in the total scores of the nasal and ocular discomfort between week 0 and week 8 in LH2171 group were significantly larger than those in P group.　 Additionally, the number of sneezes decreased significantly in LH2171 group compared with P group on weeks 9–12 compared to the number of sneezes at baseline. In study 2, no adverse effects of LH2171 on systolic bold pressure, diastolic blood pressure, pulse rate, body weight, blood and urinalysis parameters were reported.Clinical trial registration: UMIN000027791 (study 1), UMIN000029058 (study 2).Conclusion: Daily intake of LH2171 for 12 weeks may regulate immune function and improve nasal and ocular symptoms in the subjects with mite or house dust allergy.

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