scholarly journals Effects of Lactobacillus plantarum PS128 on Depressive Symptoms and Sleep Quality in Self-Reported Insomniacs: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial

Nutrients ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 2820
Author(s):  
Yu-Ting Ho ◽  
Ying-Chieh Tsai ◽  
Terry B. J. Kuo ◽  
Cheryl C. H. Yang
Keyword(s):  
Depressive Symptoms ◽  
Sleep Quality ◽  
Lactobacillus Plantarum ◽  
Animal Studies ◽  
Sleep Stage ◽  
Pilot Trial ◽  
Control Group ◽  
Deep Sleep ◽  
Daily Consumption ◽  
Double Blind

Recent animal studies have supported that Lactobacillus plantarum PS128 (PS128) can reduce the severity of anxiety and depression. However, previous studies did not focus on the sleep quality and mood of humans. This study determines whether PS128 reduces the severity of anxiety and depressive symptoms, regulates autonomic nervous system function, and improves sleep quality. Forty participants between 20 and 40 years of age with self-reported insomnia were randomly assigned to two groups, a PS128 group and a placebo group, in a double-blind trial. Participants took two capsules of either PS128 or a placebo after dinner for 30 days. Study measures included subjective depressive symptoms, anxiety and sleep questionnaires, and miniature-polysomnography recordings at baseline and on the 15th and 30th days of taking capsules. Overall, all outcomes were comparable between the two groups at baseline and within the 30-day period, yet some differences were still found. Compared to the control group, the PS128 group showed significant decreases in Beck Depression Inventory-II scores, fatigue levels, brainwave activity, and awakenings during the deep sleep stage. Their improved depressive symptoms were related to changes in brain waves and sleep maintenance. These findings suggest that daily administration of PS128 may lead to a decrease in depressive symptoms, fatigue level, cortical excitation, and an improvement in sleep quality during the deep sleep stage. Daily consumption of PS128 as a dietary supplement may improve the depressive symptoms and sleep quality of insomniacs, although further investigation is warranted.

Toxicity in a double-blind, placebo-controlled pilot trial with D-penicillamine and metacycline in secondary progressive multiple sclerosis

1998 ◽  
Vol 4 (2) ◽  
pp. 74-78 ◽  
Author(s):  
B Dubois ◽  
M B D'Hooghe ◽  
K De Lepeleire ◽  
P Ketelaer ◽  
G Opdenakker ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Pilot Trial ◽  
Progressive Multiple Sclerosis ◽  
Secondary Progressive Multiple Sclerosis ◽  
Tissue Type ◽  
Control Group ◽  
Double Blind ◽  
Gelatinase B ◽  
Double Blind Placebo ◽  
Secondary Progressive

The serine proteinase tissue-type plasminogen activator (t-PA) and the metalloproteinase gelatinase B (MMP-9) have recently been demonstrated in MS lesions. Both enzymes are interconnected in an enzyme cascade which contributes to destruction of the blood brain barrier and demyelination and both enzymes are inhibited by D-penicillamine. Metacycline was shown in in vitro experiments to inhibit gelatinase B. The combination of peroral D-penicillamine plus metacycline was evaluated in a double-blind placebo-controlled way in two groups of 10 patients suffering from secondary progressive multiple sclerosis. The major objectives of this pilot trial were to examine the safety of this combination and the possibility of blinding, while the effect on disease progression was considered as a secondary endpoint. Over a follow-up period of 1 year and in this selected patient group, there was no significant improvement in the Expanded Disability Status Scale score (EDSS) as compared with that of the placebo-control group. Toxicity was too high to consider additional trials with this combination of metalloproteinase inhibitors. Although peroral treatment is by most MS patients acknowledged as a major improvement in treatment compliance, one has to await the development of more selective and efficaceous protease inhibitors than those used in the combination therapy described here.

Poor sleep quality in systemic lupus erythematosus: does it depend on depressive symptoms?

Lupus ◽  
2014 ◽  
Vol 23 (13) ◽  
pp. 1350-1357 ◽  
Author(s):  
L Palagini ◽  
C Tani ◽  
R M Bruno ◽  
A Gemignani ◽  
M Mauri ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Depressive Symptoms ◽  
Sleep Quality ◽  
Lupus Erythematosus ◽  
Sleep Disturbances ◽  
Control Group ◽  
Poor Sleep ◽  
Systemic Lupus ◽  
Poor Sleep Quality ◽  
Obstructive Sleep

Objectives Sleep disturbances are frequently observed in rheumatic diseases including systemic lupus erythematosus (SLE). This study aimed at evaluating the prevalence of insomnia, poor sleep quality and their determinants in a cohort of SLE patients. Methods Eighty-one consecutive SLE female patients were evaluated in a cross-sectional study. The Pittsburgh Sleep Quality Index (PSQI), the Insomnia Severity Index (ISI), the Beck Depression Inventory (BDI) and the Self-rating Anxiety Scale (SAS) were administered. Patients with previous diagnosis of obstructive sleep apnea or restless legs syndrome were excluded. Fifty-three women with hypertension (without SLE) were enrolled as control group (H). Results In the SLE cohort poor sleep quality (65.4% vs 39.6%, p < 0.01) and difficulty in maintaining sleep and/or early morning awakening (65.4% vs 22.6%, p < 0.001), but not insomnia (33.3% vs 22.6%, p = ns), were more prevalent than in H. Depressive symptoms were present in 34.6% of SLE vs 13.2% H patients ( p < 0.001) while state anxiety was more common in H patients (H 35.8% vs SLE 17.3%, p < 0.005). SLE was associated with a 2.5-times higher probability of presenting poor sleep quality in comparison to H (OR 2.5 [CI 1.21–5.16]). After adjusting for confounders, both depressive symptoms (OR 4.4, [1.4–14.3]) and use of immunosuppressive drugs (OR 4.3 [CI 1.3–14.8]) were significantly associated with poor sleep quality in SLE patients. Furthermore, poor sleep quality was not associated either with disease duration or activity. Conclusions In a cohort of SLE women, insomnia and poor sleep quality, especially difficulties in maintaining sleep, were common. Depressive symptoms might be responsible for the higher prevalence of poor sleep quality in SLE.

Effect of a yoghurt drink containing Lactobacillus strains on bacterial vaginosis in women – a double-blind, randomised, controlled clinical pilot trial

2018 ◽  
Vol 9 (1) ◽  
pp. 35-50 ◽  
Author(s):  
C. Laue ◽  
E. Papazova ◽  
A. Liesegang ◽  
A. Pannenbeckers ◽  
P. Arendarski ◽  
...  
Keyword(s):  
Bacterial Vaginosis ◽  
Pilot Trial ◽  
Group Versus ◽  
Lactobacillus Delbrueckii ◽  
Control Group ◽  
Fisher Exact Test ◽  
Intervention Period ◽  
Double Blind ◽  
Increased Risk ◽  
Amsel Criteria

Bacterial vaginosis (BV) is characterised by a depletion of lactobacilli in favour of an overgrowth of anaerobic bacteria. It is associated with increased risk for urogenital infections and abortion. In this study we assessed the effect of a yoghurt drink containing Lactobacillus strains on BV. The strains had been isolated from healthy pregnant women and selected for acidification capacity, production of H2O2, glycogen utilisation, bile salt tolerance and inhibition of pathogens. Using Amsel criteria BV was diagnosed in 36 women aged ≥18 years with stable menstrual cycle or menopause. They were treated with oral metronidazole for 7 days (2×500 mg/d). Starting with the treatment, women consumed twice daily either verum or placebo during 4 weeks. Verum was 125 g yoghurt containing (besides Lactobacillus delbrueckii ssp. bulgaricus and Streptococcus thermophilus) living strains Lactobacillus crispatus LbV 88 (DSM 22566), Lactobacillus gasseri LbV 150N (DSM 22583), Lactobacillus jensenii LbV 116 (DSM 22567) and Lactobacillus rhamnosus LbV96 (DSM 22560), each 1×107 cfu/ml; placebo was 125 g chemically acidified milk. After 4 weeks of intervention 0 of 17 had BV in the verum group versus 6 of 17 in the s.a. control (0.018 in Fisher Exact test). Amsel score decreased during the intervention period by 4.0 (median) (4.0; 3.0) (25th; 75th percentile) in the verum group compared to 2.0 (4.0; 0.0) in the control group (P=0.038 in Mann-Whitney test). Discharge and odour (Amsel criteria 2+3) also decreased by 2.0 (2.0; 1.0) in the verum compared to 1.0 (2.0; 0.0) in the control group (P=0.01) and differed after 4 weeks intervention between the groups 0.0 (0.0; 0.0) versus 1.0 (0.0; 2.0) (P=0.001). Nugent score decreased during the intervention period by 5.5 (7.0;2.3) in the verum compared to 3.0 (6.0;0.5) in the control group (P=0.158). Additional intake of yoghurt containing these probiotic strains improved the recovery rate and symptoms of BV and tended to improve the vaginal microbial pattern.

scholarly journals Effect of Oral Ingestion of Low-Molecular Collagen Peptides Derived from Skate (Raja Kenojei) Skin on Body Fat in Overweight Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

Marine Drugs ◽  
2019 ◽  
Vol 17 (3) ◽  
pp. 157 ◽  
Author(s):  
Young Tak ◽  
Yun Kim ◽  
Jeong Lee ◽  
Yu-Hyun Yi ◽  
Young Cho ◽  
...  
Keyword(s):  
Body Fat ◽  
Animal Studies ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Collagen Peptides ◽  
Collagen Peptide ◽  
Skin Collagen ◽  
Overweight Adults

Recent animal studies found the potential of a collagen peptide derived from skate skin to have anti-obesity effects through the suppression of fat accumulation and regulation of lipid metabolism. However, no studies have yet been performed in humans. Here, this very first human randomized, placebo-controlled, and double-blinded study was designed to investigate the efficacy and tolerability of skate skin collagen peptides (SCP) for the reduction of body fat in overweight adults. Ninety healthy volunteers (17 men) aged 41.2 ± 10.4 years with a mean body mass index of 25.6 ± 1.9 kg/m2 were assigned to the intervention group (IG), which received 2000 mg of SCP per day or to the control group (CG) given the placebo for 12 weeks and 81 (90%) participants completed the study. Changes in body fat were evaluated using dual energy X-ray absorptiometry as a primary efficacy endpoint. After 12 weeks of the trial, the percentage of body fat and body fat mass (kg) in IG were found to be significantly better than those of subjects in CG (−1.2% vs. 2.7%, p = 0.024 and −1.2 kg vs. 0.3 kg, p = 0.025). Application of SCP was well tolerated and no notable adverse effect was reported from both groups. These results suggest the beneficial potential of SCP in the reduction of body fat in overweight adults.

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 Repeated oral ketamine for out-patient treatment of resistant depression: randomised, double-blind, placebo-controlled, proof-of-concept study

2018 ◽  
Vol 214 (1) ◽  
pp. 20-26 ◽  
Author(s):  
Yoav Domany ◽  
Maya Bleich-Cohen ◽  
Ricardo Tarrasch ◽  
Roi Meidan ◽  
Olga Litvak-Lazar ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Rating Scale ◽  
Control Group ◽  
Number Needed To Treat ◽  
Proof Of Concept ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Oral Ketamine ◽  
Group A ◽  
Resistant Depression

BackgroundKetamine has been demonstrated to improve depressive symptoms.AimsEvaluation of efficacy, safety and feasibility of repeated oral ketamine for out-patients with treatment-resistant depression (TRD).MethodIn a randomised, double-blind, placebo-controlled, proof-of-concept trial, 41 participants received either 1 mg/kg oral ketamine or placebo thrice weekly for 21 days (ClinicalTrials.gov Identifier: NCT02037503). Evaluation was performed at baseline, 40 and 240 min post administration and on days 3, 7, 14 and 21. The main outcome measure was change in Montgomery–Åsberg Depression Rating Scale (MADRS).ResultsTwenty-two participants were randomised to the ketamine group, and 19 to the control, with 82.5% (n = 33) completing the study. In the ketamine group, a decrease in depressive symptoms was evident at all time points, whereas in the control group a decrease was evident only 40 min post administration. The reduction in MADRS score on day 21 was 12.75 in the ketamine group versus 2.49 points with placebo (P < 0.001). Six participants in the ketamine group (27.3%) achieved remission compared with none of the controls (P < 0.05). The number needed to treat for remission was 3.7. Side-effects were mild and transient.ConclusionsRepeated oral ketamine produced rapid and persistent amelioration of depressive symptoms in out-patients with TRD, and was well tolerated. These results suggest that add-on oral ketamine may hold significant promise in the care of patients suffering from TRD in the community.Declaration of interestNone.

scholarly journals Efficacy of transcutaneous electrical acupoint stimulation combined with diazepam for acute alcohol withdrawal syndrome: A double-blind randomized sham-controlled trial

2020 ◽  
Vol 48 (4) ◽  
pp. 030006052091005
Author(s):  
Yun Song ◽  
Xiaobin Xue ◽  
Haibin Han ◽  
Cuiluan Li ◽  
Jia Jian ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Alcohol Withdrawal ◽  
Withdrawal Syndrome ◽  
Pittsburgh Sleep Quality Index ◽  
Controlled Trial ◽  
Alcohol Withdrawal Syndrome ◽  
Control Group ◽  
Double Blind ◽  
Improve Sleep Quality ◽  
Acupoint Stimulation

Objective To compare the efficacy of transcutaneous electrical acupoint stimulation (TEAS) combined with diazepam against diazepam alone for treatment of acute alcohol withdrawal syndrome (AWS). Methods In this double-blind randomized sham-controlled trial, men with acute AWS were randomly allocated to either a group treated with TEAS combined with diazepam (n = 57) or a control group treated with sham TEAS combined with diazepam (n = 60). Treatment was performed at four acupoints twice a day for 14 days. The Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar), visual analogue scale (VAS), Pittsburgh Sleep Quality Index (PSQI) and modified Epworth Sleepiness Scale (mESS) were used to evaluate treatment efficacy. Results All scores improved significantly in both groups during the trial. CIWA-Ar scores were lower in the TEAS group than in the control group from day 3 until the end of observation. VAS and mESS scores were also lower in the TEAS group than in the control group on day 7. VAS and PSQI scores were lower in the TEAS group on day 14. Conclusion Combining diazepam with TEAS may result in milder AWS symptoms than diazepam alone, improve sleep quality and reduce sleepiness.

scholarly journals Effectiveness of a Mindfulness-Based Group Intervention for Chinese University Students with Sleep Problems

2022 ◽  
Vol 19 (2) ◽  
pp. 755
Author(s):  
Lin Fu ◽  
Shuang Wei ◽  
Jin Cheng ◽  
Xueqi Wang ◽  
Yueyue Zhou ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
University Students ◽  
Sleep Quality ◽  
Repeated Measures ◽  
Group Intervention ◽  
Sleep Problems ◽  
Intervention Group ◽  
Control Group ◽  
Emotional Symptoms ◽  
Chinese University

The increasing prevalence of sleep disorders among university students should be taken seriously. Group counseling involving a mindfulness-based strategy may help prevent students from developing insomnia and subsequent mental health disorders. This study aimed to evaluate the ameliorating effects of a mindfulness-based group intervention on sleep problems and emotional symptoms in university students in China. Twenty-one university students (16 females, 22.71 ± 4.28 years) who were not on medication were recruited and assigned to the intervention group based on the criterion of high levels of sleep problems. Additionally, twenty-four university students (19 females, 24.50 ± 0.93 years) were included as a nonrandomized control group. Individuals in the intervention group participated in a two-hour group intervention once a week for eight sessions. All participants completed self-reported questionnaire baseline tests, postintervention tests, and one-month follow-ups on mindfulness, sleep quality, anxiety and depressive symptoms. Repeated-measures ANOVA was performed. The results revealed significant intervention effects, with significant differences observed between the two groups in mindfulness and sleep quality. However, there was no significant effect of the intervention on anxiety and depressive symptoms. This study contributes to a better understanding of the effectiveness of mindfulness-based intervention in addressing sleep problems in university students.

scholarly journals Effect of a Recliner Chair with Rocking Motions on Sleep Efficiency

Sensors ◽  
2021 ◽  
Vol 21 (24) ◽  
pp. 8214
Author(s):  
Suwhan Baek ◽  
Hyunsoo Yu ◽  
Jongryun Roh ◽  
Jungnyun Lee ◽  
Illsoo Sohn ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Quantitative Evaluation ◽  
Sleep Stage ◽  
Qualitative Evaluation ◽  
Parameter Analysis ◽  
Sleep Stages ◽  
Deep Sleep ◽  
Quality Of Sleep ◽  
Sleep Scoring

In this study, we analyze the effect of a recliner chair with rocking motions on sleep quality of naps using automated sleep scoring and spindle detection models. The quality of sleep corresponding to the two rocking motions was measured quantitatively and qualitatively. For the quantitative evaluation, we conducted a sleep parameter analysis based on the results of the estimated sleep stages obtained on the brainwave and spindle estimation, and a sleep survey assessment from the participants was analyzed for the qualitative evaluation. The analysis showed that sleep in the recliner chair with rocking motions positively increased the duration of the spindles and deep sleep stage, resulting in improved sleep quality.

Effect of live and inactivated Lactobacillus rhamnosus GG on experimentally induced rhinovirus colds: randomised, double blind, placebo-controlled pilot trial

2015 ◽  
Vol 6 (5) ◽  
pp. 631-639 ◽  
Author(s):  
M. Kumpu ◽  
R.A. Kekkonen ◽  
R. Korpela ◽  
S. Tynkkynen ◽  
S. Järvenpää ◽  
...  
Keyword(s):  
Large Scale ◽  
Viral Infections ◽  
Pilot Trial ◽  
Lactobacillus Rhamnosus ◽  
Probiotic Strain ◽  
Control Group ◽  
Lactobacillus Rhamnosus Gg ◽  
Double Blind ◽  
Challenge Virus ◽  
Rhinovirus Infection

The aim of this work was to investigate the usability of an experimental rhinovirus model in probiotic trials aiming to assess effectiveness in viral infections, and to provide preliminary data of live and inactivated probiotic Lactobacillus rhamnosus GG for larger-scale trials utilising the model. 59 subjects were randomised to receive 100 ml of fruit juice supplemented with 109 cfu of live or heat-inactivated (by spray-drying) L. rhamnosus GG or control juice daily for six weeks. After three weeks subjects were intranasally inoculated with experimental rhinovirus. Infection rate (at least one positive culture for challenge virus on five days following inoculation or at least four-fold rise in antibody response to challenge virus) was 14/19 in the group receiving live probiotic strain and 18/20 both in the group receiving heat-inactivated probiotic strain and in the control group (P=0.36). The occurrence and severity of cold symptoms on the five days following the inoculation was lowest in the group receiving live probiotic strain (P=0.45). This trial was the first one dedicated to the investigation of the effect of probiotics using the experimental rhinovirus model. The model showed potential for demonstration of efficacy of probiotics in controlled respiratory viral infections. Occurrence and severity of cold symptoms and number of subjects with rhinovirus infection was lowest in the group receiving live L. rhamnosus GG, but differences were not statistically significant. Further large-scale studies are needed to demonstrate the efficacy of L. rhamnosus GG in respiratory infections.

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