scholarly journals 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 ◽  
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.

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 Effects of Porphyra tenera Supplementation on the Immune System: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2020 ◽  
Author(s):  
Su-Jin Jung ◽  
Hui-Yeon Jang ◽  
Eun-Soo Jung ◽  
Soon-Ok Noh ◽  
Sang-Wook Shin ◽  
...  
Keyword(s):  
Placebo Group ◽  
Nk Cell ◽  
Killer Cell ◽  
Cell Activity ◽  
Healthy Adults ◽  
Controlled Clinical Trial ◽  
Nk Cell Activity ◽  
Double Blind ◽  
Porphyra Tenera ◽  
Significant Difference

Objective: The purpose of this study was to determine if Porphyra tenera extract (PTE) has immune-enhancing effects and is safe in healthy adults. Methods: Subjects (3x103 ≤ peripheral blood leukocyte levels < 8x103 cells/μl) who met the inclusion criteria were recruited for this study. Enrolled subjects (n=120) were randomly assigned to either the PTE group (n=60) who were given 2.5 g/day of PTE (as Porphyra tenera extract) in capsule form or the placebo group (n=60) who were given crystal cellulose capsules with the identical appearance, weight, and flavor as the PTE capsules for 8 weeks. Outcomes were assessed by measuring natural killer cell (NK-cell) activity, cytokines, and upper respiratory infection (URI), and safety parameters were assessed at baseline and 8 weeks. Results: Compared to baseline, NK cell activity (%) increased for all effector cell to target cell ratios in the PTE group after 8 weeks, but there were no changes in the placebo group (p<0.1). Subgroup analysis of 101 subjects without an URI revealed that NK-cell activity in the PTE group tended to be increased for all E:T ratios (E:T=12.5:1 p=0.068; E:T=25:1 p=0.036; E:T=50:1 p=0.081) compared to the placebo group. There was a significant difference between these two groups for the E:T=25:1 ratio, which increased from 20.3±12.0% at baseline to 23.2±12.4% after 8 weeks in the PTE group (p=0.036). There was no significant difference in levels of cytokines between these two groups. Conclusions: PTE supplementation appears to enhance immune function by improving NK-cell activity without adverse effects in healthy adults.

N-acetylcysteine does not affect the lymphocyte proliferation and natural killer cell activity responses to exercise

1998 ◽  
Vol 275 (4) ◽  
pp. R1227-R1231
Author(s):  
H. B. Nielsen ◽  
N. H. Secher ◽  
M. Kappel ◽  
B. K. Pedersen
Keyword(s):  
Natural Killer ◽  
Lymphocyte Proliferation ◽  
Nk Cell ◽  
Natural Killer Cell Activity ◽  
Killer Cell ◽  
Cell Activity ◽  
Nk Cell Activity ◽  
Double Blind ◽  
Significant Difference ◽  
Ergometer Rowing

This study evaluated whether N-acetylcysteine (NAC) attenuates the reduced lymphocyte proliferation and natural killer (NK) cell activity responses to exercise in humans. Fourteen oarsmen were double-blind randomized to either NAC (6 g daily for 3 days) or placebo groups. During 6-min “all-out” ergometer rowing, the concentration of lymphocytes in the peripheral blood increased, with no significant difference between NAC and placebo as reflected in lymphocyte subsets: CD4+, CD8+, CD16+, and CD19+ cells. The phytohemagglutinin-stimulated lymphocyte proliferation decreased from 9,112 ± 2,865 to 5,851 ± 1,588 cpm ( P < 0.05), but it was not affected by NAC. During exercise, the NK cell activity was elevated from 17 ± 3 to 38 ± 4% and it decreased to 7 ± 1% below the resting value 2 h into recovery. Yet, when evaluated as lytic units per CD16+ cell, the NK cell activity decreased during and after exercise without a significant effect of NAC. We conclude that NAC does not attenuate the reduction in lymphocyte proliferation and NK cell activity associated with intense exercise.

scholarly journals Effect of Welsh onion (Allium fistulosum L.) green leaf extract on immune response in healthy subjects: a randomized, double-blind, placebo-controlled study

2019 ◽  
Vol 9 (2) ◽  
pp. 123
Author(s):  
Yosuke Hirayama ◽  
Jun Takanari ◽  
Kazunori Goto ◽  
Hiroshi Ueda ◽  
Aiko Tanaka ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Leaf Extract ◽  
Nk Cell ◽  
Cell Activity ◽  
High Dose ◽  
Immune Competence ◽  
Nk Cell Activity ◽  
Welsh Onion ◽  
Double Blind ◽  
Double Blind Placebo

Background: Welsh onion belongs to genus allium. Although its medicinal benefit such as cold prevention is well known by tradition, the underlying mechanism and active components have never been elucidated. The recent study revealed that Welsh onion mucus enhances tumor necrosis factor-α and monocyte chemotactic protein-1 production from RAW 264 cells and natural killer (NK) cell activity in murine spleen cells. This mucilage was abundant in the leaf blade of Welsh onion. Thus, we investigated the effect of Welsh onion green leaf extract (GLE) on immune competence in the human clinical trial. Methods: A randomized, double-blind, placebo-controlled trial was conducted. Fifty-five healthy subjects were enrolled after the screening based on NK cell activity, and each sample (placebo, low-dose GLE or high-dose GLE) was supplemented for four weeks. The immune competence activity was evaluated through the primary endpoints that were NK cell activity and the score of immunological vigor (SIV). The SIV was calculated from lymphocyte subset analysis by flow cytometry method.Results: NK cell activity was enhanced in all supplemented groups including placebo, especially, it was significant in both GLE groups. The result of immune score showed that the immunity of high-dose GLE group did not change although it was significantly lowered in placebo group (p<0.01), suggesting that GLE ameliorated the immunity suppression. In addition, when SIV was compared between pre- and post-intake, the ratios of the improved subjects in two GLE groups were higher than that of placebo group while those of the aggravated subjects showed the opposite result. In particular, they were remarkable in high-dose GLE group.Conclusion: These results suggest that the intake of low- or high-dose GLE might positively regulate immune competence.Keywords: welsh onion, immunity, natural killer cell, clinical 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

Clinical response augments NK cell activity independent of treatment modality: a randomized double-blind placebo controlled antidepressant trial

2004 ◽  
Vol 34 (3) ◽  
pp. 491-498 ◽  
Author(s):  
M. G. FRANK ◽  
S. E. HENDRICKS ◽  
W. J. BURKE ◽  
D. R. JOHNSON
Keyword(s):  
Immune Function ◽  
Clinical Response ◽  
Rating Scale ◽  
Cell Function ◽  
Nk Cell ◽  
Cell Activity ◽  
Therapeutic Modality ◽  
Nk Cell Activity ◽  
Double Blind ◽  
Double Blind Placebo

Background. Major depressive disorder (MDD) has been associated with alterations in immune function. Suppression of natural killer (NK) cell activity (NKCA) reliably characterizes immunological alterations observed in MDD. Antidepressant pharmacotherapy has been associated with modulation of NKCA. Previous investigations into antidepressant modulation of NKCA have not employed randomized double-blind placebo controlled designs. Thus, it is unknown whether treatment-associated changes in immune function are due to drug, placebo, or spontaneous remission effects. The present investigation examined the effect of antidepressant treatment on NKCA utilizing a randomized double-blind placebo controlled experimental design.Method. Patients (N=16) met DSM-IV criteria for MDD and were randomly assigned to drug (N=8; citalopram, 20 mg/day) or placebo (N=8) under double-blind conditions. Severity and pattern of depressive symptoms were assessed by the Hamilton Depression Rating Scale (HDRS). NK cell function was measured using a standard chromium-release assay and NK cell number assessed by flow cytometry. HDRS scores, NK cell function, and NK cell numbers were collected at 0, 1, 2 and 4 weeks of treatment.Results. Clinical response was associated with augmented NKCA independent of treatment condition. Failure to respond to treatment resulted in significantly reduced NKCA over treatment interval.Conclusions. The present results suggest that alterations in the depressive syndrome, regardless of therapeutic modality, may be sufficient to modulate NKCA during antidepressant trials and thus may significantly impact on co-morbid health outcomes in MDD.

scholarly journals A Single-Center, Randomized Double-Blind Placebo-Controlled Study Evaluating the Effects of Poly-Gamma-Glutamate on Human NK Cell Activity after an 8-Week Oral Administration in Healthy Volunteers

2013 ◽  
Vol 2013 ◽  
pp. 1-6
Author(s):  
Kyung-Soo Kim ◽  
Tae-Young Lee ◽  
Jang-Hee Hong ◽  
Ahrom Kim ◽  
Sung-Jin Kim ◽  
...  
Keyword(s):  
Oral Administration ◽  
Peripheral Blood ◽  
Initial Treatment ◽  
Cytokine Production ◽  
Nk Cell ◽  
Cell Activity ◽  
Nk Cell Activity ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Low Dosage

A randomized double-blind placebo-controlled immunity study involving 99 healthy volunteers was performed to investigate the effect of poly-γ-glutamate (γ-PGA) on human natural killer (NK) cell activity in peripheral blood. The volunteers were randomly assigned to one of three groups and orally treated with solutions (25 mL) containing 0 mg (placebo), 250 mg (low dosage), or 500 mg (high dosage) ofγ-PGA. Each volunteer took one dose every 12 hours for 8 weeks. Blood samples were drawn before the initial treatment and at the 4th and the 8th weeks of treatment. NK cell activity was assessed by measuring its degranulation, cytokine production, and cytotoxicity against the K562 cell line. Our results revealed that the cytotoxic activities of NK cells from the high-dosageγ-PGA group were significantly higher (P<0.05for all comparisons) compared to the low dosage and placebo groups at weeks 4 and 8 after the initial treatment. This increase in the NK cell activity among peripheral blood mononuclear cells (PBMCs) of healthy individuals was also confirmedin vitro(as assessed by the degranulation and cytokine production). These results suggest that the oral administration ofγ-PGA induces a cell-mediated immunity by increasing the NK cell activity in humans.

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 Effects of Porphyra tenera Supplementation on the Immune System: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial

Nutrients ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 1642
Author(s):  
Su-Jin Jung ◽  
Hui-Yeon Jang ◽  
Eun-Soo Jung ◽  
Soon-Ok Noh ◽  
Sang-Wook Shin ◽  
...  
Keyword(s):  
Placebo Group ◽  
Target Cell ◽  
Effector Cell ◽  
Nk Cell ◽  
Cell Activity ◽  
Healthy Adults ◽  
Controlled Clinical Trial ◽  
Nk Cell Activity ◽  
Porphyra Tenera ◽  
Significant Difference

Objective: The purpose of this study was to determine if Porphyra tenera extract (PTE) has immune-enhancing effects and is safe in healthy adults. Methods: Subjects who met the inclusion criteria (3 × 103 ≤ peripheral blood leukocyte level ≥ 8 × 103 cells/µL) were recruited for this study. Enrolled subjects (n = 120) were randomly assigned to either the PTE group (n = 60) and were given 2.5 g/day of PTE (as PTE) in capsule form or the placebo group (n = 60) and were given crystal cellulose capsules with the identical appearance, weight, and flavor as the PTE capsules for 8 weeks. Outcomes were assessed based on measuring natural killer (NK) cell activity, cytokines level, and upper respiratory infection (URI), and safety parameters were assessed at baseline and 8 weeks. Results: Compared with baseline, NK cell activity (%) increased for all effector cell-to-target cell ratios in the PTE group after 8 weeks; however, changes were not observed in the placebo group (p < 0.10). Subgroup analysis of 101 subjects without URI showed that NK cell activity in the PTE group tended to increase for all effector cell/target cell (E:T) ratios (E:T = 12.5:1 p = 0.068; E:T = 25:1 p = 0.036; E:T = 50:1 p = 0.081) compared with the placebo group. A significant difference between the two groups was observed for the E:T = 25:1 ratio, which increased from 20.3 ± 12.0% at baseline to 23.2 ± 12.4% after 8 weeks in the PTE group (p = 0.036). A significant difference was not observed in cytokine between the two groups. Conclusion: PTE supplementation appears to enhance immune function by improving NK cell activity without adverse effects in healthy adults.

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