scholarly journals Effects of L-Theanine Administration on Stress-Related Symptoms and Cognitive Functions in Healthy Adults: A Randomized Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (10) ◽  
pp. 2362 ◽  
Author(s):  
Hidese ◽  
Ogawa ◽  
Ota ◽  
Ishida ◽  
Yasukawa ◽  
...  
Keyword(s):  
Cognitive Functions ◽  
Verbal Fluency ◽  
Controlled Trial ◽  
Depression Scale ◽  
Healthy Adults ◽  
Placebo Administration ◽  
Double Blind ◽  
Randomized Controlled ◽  
Median Split ◽  
The Mean

This randomized, placebo-controlled, crossover, and double-blind trial aimed to examine the possible effects of four weeks L-theanine administration on stress-related symptoms and cognitive functions in healthy adults. Participants were 30 individuals (nine men and 21 women; age: 48.3 ± 11.9 years) who had no major psychiatric illness. L-theanine (200 mg/day) or placebo tablets were randomly and blindly assigned for four-week administration. For stress-related symptoms, Self-rating Depression Scale, State-Trait Anxiety Inventory-trait, and Pittsburgh Sleep Quality Index (PSQI) scores decreased after L-theanine administration (p = 0.019, 0.006, and 0.013, respectively). The PSQI subscale scores for sleep latency, sleep disturbance, and use of sleep medication reduced after L-theanine administration, compared to the placebo administration (all p < 0.05). For cognitive functions, verbal fluency and executive function scores improved after L-theanine administration (p = 0.001 and 0.031, respectively). Stratified analyses revealed that scores for verbal fluency (p = 0.002), especially letter fluency (p = 0.002), increased after L-theanine administration, compared to the placebo administration, in individuals who were sub-grouped into the lower half by the median split based on the mean pretreatment scores. Our findings suggest that L-theanine has the potential to promote mental health in the general population with stress-related ailments and cognitive impairments.

scholarly journals Tolerability and Safety of a Novel Ketogenic Ester, Bis-Hexanoyl (R)-1,3-Butanediol: A Randomized Controlled Trial in Healthy Adults

Nutrients ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 2066
Author(s):  
Oliver Chen ◽  
Traci M. Blonquist ◽  
Eunice Mah ◽  
Kristen Sanoshy ◽  
Dawn Beckman ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Controlled Trial ◽  
Vital Signs ◽  
Healthy Adults ◽  
Double Blind ◽  
Safety Measures ◽  
Randomized Controlled ◽  
Gastrointestinal Tolerability ◽  
Blood And Urine Samples ◽  
At Home

Nutritional ketosis is a state of mildly elevated blood ketone concentrations resulting from dietary changes (e.g., fasting or reduced carbohydrate intake) or exogenous ketone consumption. In this study, we determined the tolerability and safety of a novel exogenous ketone diester, bis-hexanoyl-(R)-1,3-butanediol (BH-BD), in a 28-day, randomized, double-blind, placebo-controlled, parallel trial (NCT04707989). Healthy adults (n = 59, mean (SD), age: 42.8 (13.4) y, body mass index: 27.8 (3.9) kg/m2) were randomized to consume a beverage containing 12.5 g (Days 0–7) and 25 g (Days 7–28) of BH-BD or a taste-matched placebo daily with breakfast. Tolerability, stimulation, and sedation were assessed daily by standardized questionnaires, and blood and urine samples were collected at Days 0, 7, 14, and 28 for safety assessment. There were no differences in at-home composite systemic and gastrointestinal tolerability scores between BH-BD and placebo at any time in the study, or in acute tolerability measured 1-h post-consumption in-clinic. Weekly at-home composite tolerability scores did not change when BH-BD servings were doubled. At-home scores for stimulation and sedation did not differ between groups. BH-BD significantly increased blood ketone concentrations 1-h post-consumption. No clinically meaningful changes in safety measures including vital signs and clinical laboratory measurements were detected within or between groups. These results support the overall tolerability and safety of consumption of up to 25 g/day BH-BD.

scholarly journals The Effect of a Transdermal Scopolamine Patch on Postoperative Nausea and Vomiting after Retromastoid Craniectomy with Microvascular Decompression: A Preliminary Single Center, Double-Blind, Randomized Controlled Trial

2020 ◽  
Vol 9 (1) ◽  
pp. 156 ◽  
Author(s):  
Hyun Hee Lee ◽  
Hyun-Mi Kim ◽  
Ji Eun Lee ◽  
Young-Tae Jeon ◽  
Sanghon Park ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Placebo Group ◽  
Microvascular Decompression ◽  
Postoperative Nausea ◽  
Controlled Trial ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Double Blind ◽  
Randomized Controlled ◽  
The Mean

Background: We performed this prospective double-blind randomized controlled trial to identify the effect of a preoperative prophylactic transdermal scopolamine (TDS) patch on postoperative nausea and vomiting (PONV) after retromastoid craniectomy with microvascular decompression (RMC-MVD). Methods: We recruited 38 patients undergoing RMC-MVD and randomized them into two groups: the TDS group (n = 19, application of the TDS patch) and placebo group (n = 19, application of a sham patch). Nausea (as a self-reported 100-mm visual analog scale (VAS) score; range, 0 (no nausea) to 10 (worst nausea)), vomiting, and the use of antiemetics were the primary endpoints. Results: There was no significant difference in terms of the incidence of PONV (73.7% in the TDS group and 78.9% in the placebo group; p = 1.00) between the groups. However, the mean nausea VAS score was significantly different at arrival to the general ward (0.93 ± 1.71 in the TDS group vs. 2.52 ± 2.85 in the placebo group; p = 0.046), and throughout the study period (0.03 ± 0.07 in the TDS group vs. 0.44 ± 0.71 in the placebo group; p = 0.029). Rescue antiemetics were more frequently used in the placebo group than in the TDS group (9 (47.4%) vs. 2 (10.5%), respectively; p = 0.029). The mean number of antiemetics used throughout the study period was significantly higher in the placebo group than in the TDS group (1.37 ± 2.19 vs. 0.16 ± 0.50, respectively; p = 0.029). Conclusions: The preoperative prophylactic use of a TDS patch was safe and effective in the management of PONV after RMC-MVD in terms of the severity of PONV and the use of rescue antiemetics.

scholarly journals Effects of Chronic L-theanine on Stress-related Symptoms and Cognitive Function in a Non-clinical Population: A Randomized Controlled Trial (P06-106-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Hiroshi Kunugi ◽  
Shinsuke Hidese ◽  
Shintaro Ogawa ◽  
Miho Ota ◽  
Zenta Yasukawa ◽  
...  
Keyword(s):  
Executive Function ◽  
Placebo Group ◽  
Crossover Study ◽  
Cognitive Functions ◽  
Controlled Trial ◽  
Depression Scale ◽  
Clinical Population ◽  
Double Blind ◽  
Funding Sources ◽  
Brief Assessment

Abstract Objectives This randomized, placebo-controlled, and double-blind, crossover study aimed to investigate the effects of chronic L-theanine (Suntheanine®) administration on stress-related symptoms and cognitive functions in a non-clinical population. Methods Participants were 9 men and 21 women (mean age: 48.3 ± 11.9 years) who had no psychiatric illness of clinical level. L-theanine (200 mg/day) or placebo tablets were randomly assigned to participants for 4 weeks administration. After 2 weeks of wash-out period, the crossover study was continued for 4 weeks. Stress related symptoms were assessed using Self-rating Depression Scale (SDS), State-Trait Anxiety Inventory (STAI), and Pittsburgh Sleep Quality Index (PSQI). Cognitive functions were assessed with Brief Assessment of Cognition in Schizophrenia (BACS). Results SDS, STAI-trait, and PSQI scores significantly decreased after 4 weeks of L-theanine administration, while there were no significant changes after placebo. Verbal fluency and executive function scores of BACS significantly increased (p = 0.001 and 0.031) after L-theanine, but not placebo, administration. Changes in sleep latency, sleep disturbance, and use of sleep medication subscales of PSQI were significantly better in the L-theanine than in the placebo group. Changes in SDS and PSQI total scores also tended to be better in L-theanine than in placebo group. The rate of individuals who showed an improvement in BACS executive function score (5 or more) was significantly greater in L-theanine group than in placebo group. There was no significant adverse event after chronic L-theanine administration. Conclusions The results suggest that 4 weeks of L-theanine (200 mg/day) administration is safe and effective on stress-related symptoms and cognitive functions in a non-clinical population. Funding Sources This research was funded by Taiyo Kagaku, Co. Ltd.

scholarly journals Memantine Augmentation Improves Symptoms in Serotonin Reuptake Inhibitor-Refractory Obsessive-Compulsive Disorder: A Randomized Controlled Trial

2017 ◽  
Vol 51 (06) ◽  
pp. 263-269 ◽  
Author(s):  
Atieh Modarresi ◽  
Mehdi Sayyah ◽  
Setareh Razooghi ◽  
Kaveh Eslami ◽  
Mohammadreza Javadi ◽  
...  
Keyword(s):  
Treatment Response ◽  
Controlled Trial ◽  
Large Body ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Compulsive Disorder ◽  
Randomized Controlled ◽  
Clinical Benefits ◽  
The Mean ◽  
To Receive

Abstract Introduction There is a large body of evidence on the clinical benefits of augmentation therapy with glutamate-modulating agents, such as memantine in reducing OCD symptoms. Methods A double-blind, placebo-controlled trial was conducted on SRIrefractory OCD patients. Thirty-two patients were randomized to receive either 20 mg/day memantine or placebo augmentation and were visited at baseline and every 4 weeks for 12 weeks. Results were measured using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Results The Y-BOCS total score was significantly reduced in the memantine group at the end of weeks 8 and 12, while no improvement was observed in the placebo group throughout the trial. A reduction of 40.9% in the mean Y-BOCS total score by week 12 in the memantine group resulted in 73.3% of patients achieving treatment response. The findings showed that a time to effect of 8 weeks was necessary to observe significant improvement in OCD symptoms, while treatment response was only seen after 12 weeks of memantine augmentation. Discussion Memantine is an effective and well-tolerated augmentation in severe OCD patients refractory to SRI monotherapy.

scholarly journals Circulating Ionized Magnesium: Comparisons with Circulating Total Magnesium and the Response to Magnesium Supplementation in a Randomized Controlled Trial

Nutrients ◽  
2020 ◽  
Vol 12 (1) ◽  
pp. 263 ◽  
Author(s):  
Mary R. Rooney ◽  
Kyle D. Rudser ◽  
Alvaro Alonso ◽  
Lisa Harnack ◽  
Amy K. Saenger ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Adult Population ◽  
Biologically Active ◽  
Double Blind ◽  
The Public ◽  
Randomized Controlled ◽  
The Mean ◽  
Using Data ◽  
Intent To Treat

Ionized Mg (iMg) is considered the biologically active fraction of circulating total Mg (tMg). It is possible that iMg may be a more physiologically relevant marker than tMg. Using data from a double-blind pilot randomized controlled trial, we tested (1) whether oral Mg supplementation will increase iMg concentrations compared with placebo and (2) the relationship between iMg and tMg at baseline. Additionally, we evaluated the agreement between iMg measured in fresh whole blood versus stored samples. A total of fifty-nine participants were randomized 1:1 to oral Mg supplementation (400 mg/day, Mg Oxide) or placebo for 10 weeks. Fasting blood samples were obtained at baseline and follow-up. The analysis used linear regression and an intent-to-treat approach. Participants were generally healthy, the mean age was 62, and 73% were female. The baseline iMg and tMg were modestly and positively associated (r = 0.50). The ratio of baseline iMg to tMg was 64%. The mean supplement effect on iMg was 0.03 mmol/L (95% CI:0.01, 0.05) for Mg supplementation versus placebo. The supplement effect on iMg was not statistically significantly different according to baseline iMg status (above/below median). Compared to fresh blood, iMg was consistently higher in refrigerated and frozen samples by 0.14 and 0.20 mmol/L, respectively. In this relatively healthy adult population, Mg supplementation over 10 weeks resulted in increased iMg concentrations. Whether iMg is a more appropriate measure of Mg status than tMg, and the public health or clinical utility of measuring iMg remains to be determined.

scholarly journals Ormeloxifene versus Medroxyprogesterone Acetate (MPA) in the Treatment of Dysfunctional Uterine Bleeding: A Double-Blind Randomized Controlled Trial

2011 ◽  
Vol 3 (1) ◽  
pp. 21-24 ◽  
Author(s):  
MB Bellad ◽  
D Mekhala ◽  
Jyotsna Shravage ◽  
MS Ganachari ◽  
HA Dhumale
Keyword(s):  
Blood Loss ◽  
Medroxyprogesterone Acetate ◽  
Endometrial Thickness ◽  
Controlled Trial ◽  
Dysfunctional Uterine Bleeding ◽  
Double Blind ◽  
Randomized Controlled ◽  
Group A ◽  
The Mean ◽  
Group B

ABSTRACT Objective To find the effectiveness of ormeloxifene vs medroxyprogesterone acetate (MPA) to reduce blood loss in dysfunctional uterine bleeding (DUB). Materials and methods: Design—A double blind randomized controlled trial. Data source—The women attending gynecology OPD in teaching hospital attached to Jawaharlal Nehru Medical College, Belgaum, India for menorrhagia, meeting the selection criteria were enrolled into the study. Randomization—Computer-generated randomization, with block size of two, was done into two groups. Intervention—One group (group A) received capsule ormeloxifene 60 mg to be taken two days a week at an interval of 3 days, and a placebo form of medroxyprogesterone acetate for 21 days starting from day 2 to 5 of the menstrual cycle for three consecutive cycles. Other group (group B) received medroxyprogesterone acetate (MPA) 10 mg for 21 days starting from day 2 to 5 of the menstrual cycle, and a placebo form of ormeloxifene for 2 days a week with an interval of 3 days for three consecutive cycles. The drug and its placebo were in similar capsular form. All the participants were ensured to use the similar type of sanitary napkins, and transvaginal ultrasonography was done to note the endometrial thickness (ET) before and after the drug therapy. Blinding—The department of clinical pharmacy prepared the drug packets and kept the randomization code till the data was analyzed, thus ensuring the double blinding. Outcome Participants were interviewed during subsequent cycle. Pictorial blood assessment chart (PBAC) score was used to calculate blood loss during menses at the first and subsequent three months. Data analysis The mean PBAC scores and endometrial thickness were compared in two groups. Results The mean pretreatment PBAC scores in group A and group B were 262.26 and 238.71 ml respectively. The mean PBAC scores at the end of the study period were 73 and 108 in group A and B respectively, reporting an overall reduction in mean blood loss by 85.7 and 54.76% (p = 0.0205) in group A and B respectively. Thus, there was a significant reduction in blood loss in the group receiving ormeloxifene. The reduction in the mean endometrial thickness was more in ormeloxifene group. However, this was not statistically significant (p = 0.0942). Conclusion Ormeloxifene is more effective as compared to MPA in reducing the blood loss in the treatment of DUB.

Treatment Outcome of Auditory and Frontal Dual-Site rTMS in Tinnitus Patients and Changes in Magnetoencephalographic Functional Connectivity after rTMS: Double-Blind Randomized Controlled Trial

2019 ◽  
Vol 24 (6) ◽  
pp. 293-298 ◽  
Author(s):  
Tae-Soo Noh ◽  
Jeong-Sug Kyong ◽  
Moo Kyun Park ◽  
Jun Ho Lee ◽  
Seung Ha Oh ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Sham Group ◽  
Controlled Trial ◽  
Post Treatment ◽  
Double Blind ◽  
Randomized Controlled ◽  
Band Power ◽  
The Mean ◽  
Dual Site

Background: Recently, the role of neural modulation in nonauditory cortices via repetitive transcranial magnetic stimulation (rTMS) for tinnitus control has been emphasized. It is now more compelling to consider these nonauditory cortices and the whole “tinnitus network” as targets for tinnitus treatment to achieve a better outcome. Objective: We aimed to investigate the effects of active dual-site rTMS treatment in tinnitus reduction using a double-blind randomized controlled trial. Method: In study 1, the dual-site rTMS treatment group (n = 17) was treated daily for 4 consecutive days. The sham group (n = 13) also visited the clinic for 4 days; they received sham treatment for the same duration as the dual-site rTMS treatment group. In study 2, the rTMS treatment protocol was exactly the same as in study 1. Magnetoencephalography recordings were performed before and 1 week after the last rTMS treatment. The outcome measure was the Tinnitus Handicap Inventory (THI) score and the visual analog scale score. The effects of treatment were assessed 1, 2, 4, and 8 weeks after rTMS treatment in study 1. Then the mean band power and network changes were compared between pre- and post-treatment values after rTMS in study 2. Result: Patients in the dual-site rTMS treatment group exhibited significantly improved THI scores at 2, 4, and 8 weeks after rTMS treatment compared with the pretreatment scores. However, the sham group did not show any significant reduction in THI scores. When the mean band power changes were compared between pre- and post-treatment assessments, an increased oscillation power was observed in the alpha band after rTMS. Conclusion: A beneficial effect of rTMS on tinnitus suppression was found in the dual-site active rTMS group, but not in the sham rTMS group.

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