scholarly journals EFFECTS OF ALPHA-S1-CASEIN TRYPTIC HYDROLYSATE AND L-THEANINE ON SLEEP DISORDER AND PSYCHOLOGICAL COMPONENTS: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

2019 ◽  
Vol 19 (1) ◽  
pp. 47-55
Author(s):  
Chee Huei Phing ◽  
Ong Yong Chee
Keyword(s):  
Placebo Group ◽  
Sleep Quality ◽  
Sleep Disorder ◽  
Sleep Disturbances ◽  
Intervention Group ◽  
Milk Powder ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Tryptic Hydrolysate

Sleep disorder is common among the general population. A nutritional supplement containing alpha-s1-casein tryptic hydrolysate and L-theanine was evaluated for its effects in improving sleep quality. The study was conducted using a double-blind randomized trial.  Intervention group received once-daily capsules of 150 mg alpha s1 casein tryptic hydrolysate and 50 mg L-theanine, and the control group were given placebo (150 mg skimmed milk powder) for four weeks. The outcome measurements were assessed on weekly basis using PSQI, DASS-21, clinical and biochemical parameters. ANOVA test were used to assess within group differences and ANCOVA were used to check for differences between groups. Significantly lower (better) sleep latency score, sleep disturbances score and daytime dysfunction score were demonstrated on week-4 in intervention group compared to placebo group. Profound differences were observed between the two groups for anxiety and stress scores from week-3 onwards, in which lower anxiety and stress scores were observed in intervention group compared to placebo group. In addition, significantly lower depression score in intervention group compared to placebo group on week-4 was observed. Intervention supplement has demonstrated potent effects in relieving anxiety, stress, depression and sleep quality.

scholarly journals Melatonin Supplementation for Six Weeks Had No Effect on Arterial Stiffness and Mitochondrial DNA in Women Aged 55 Years and Older with Insomnia: A Double-Blind Randomized Controlled Study

2021 ◽  
Vol 18 (5) ◽  
pp. 2561
Author(s):  
Yonghwan Kim ◽  
Hee-Taik Kang ◽  
Duk-Chul Lee
Keyword(s):  
Insulin Resistance ◽  
Mitochondrial Dna ◽  
Placebo Group ◽  
Arterial Stiffness ◽  
Sleep Quality ◽  
Copy Number ◽  
Quality Index ◽  
Controlled Study ◽  
Double Blind ◽  
Randomized Controlled

Melatonin is a hormone produced in the pineal gland that controls sleep and circadian rhythm. Some studies have reported antioxidant and anti-inflammatory effects of melatonin that could benefit cardiometabolic function; however, there is a lack of evidence to support these assertions. The aim of this study was to investigate whether melatonin has beneficial effects on arterial stiffness and mitochondrial deoxyribonucleic acid (DNA) in humans. Methods: This study was designed as a double-blind randomized controlled study. Thirty-eight healthy women aged 55 years and older were enrolled. All had insomnia (Pittsburgh Sleep Quality Index (PSQI) ≥ 5), not treated with any medications, for at least three months before enrollment. Subjects were divided into a melatonin and a placebo group according to melatonin supplementation. The melatonin group took 2 mg melatonin every night for six weeks. The cardio–ankle vascular index (CAVI) was used as an indicator of arterial stiffness. After six weeks, CAVI, mitochondrial DNA (mtDNA) copy number in white blood cells (WBCs), and other metabolic indices, such as homeostasis model assessment of insulin resistance (HOMA-IR), were checked. Results: Sleep quality index using PSQI was improved in the melatonin group from a score of 11 to 8 (p = 0.01), but did not change significantly in the control group. However, there was no significant intergroup difference in PSQI. Systolic blood pressure (SBP) decreased in the melatonin group from 135 to 128 mmHg (p = 0.015), while remaining stable in the placebo group. Right CAVI, mitochondrial DNA copy number, and HOMA-IR were not altered in either group. There were no intergroup differences in CAVI, mtDNA, HOMA-IR, or SBP between baseline and week six. Conclusions: We found no evidence that melatonin supplementation improved cardiometabolic parameters like arterial stiffness, mtDNA, or insulin resistance compared to the placebo between baseline and week six. Sleep quality was improved in the melatonin group. Further research, including longer-term studies with higher doses of melatonin, is warranted.

A Controlled Study of Trancopal in the Treatment of Sleep Disturbances Due to Anxiety

1978 ◽  
Vol 6 (2) ◽  
pp. 115-120 ◽  
Author(s):  
J M T Warnock
Keyword(s):  
Placebo Group ◽  
Side Effects ◽  
Sleep Disturbances ◽  
Controlled Study ◽  
Night Time ◽  
Double Blind ◽  
Matching Placebo ◽  
Daily Record ◽  
Single Night

Sixty-eight patients presenting with sleep disturbances due to mild neurotic anxiety were treated for two weeks with a single night-time dose of 400 mg Trancopal or matching placebo under double-blind conditions. Patients kept a daily record of the quality of their sleep and the observer carried out a weekly rating of anxiety using a modified Hamilton scale. By Day 7 patients receiving Trancopal had a significantly better rating for sleep and mean Hamilton scores for day-time anxiety than the placebo group. Side-effects were minimal. It was concluded that for patients with sleep disturbances due to neurotic anxiety Trancopal is a well tolerated and effective alternative to the hypnotics.

scholarly journals L-Carnitine supplementation ameliorates serum tumor necrosis factor-alpha and matrix metalloproteinase-3 in knee osteoarthritis women

2017 ◽  
Vol 12 (1) ◽  
pp. 28 ◽  
Author(s):  
Reza Mahdavi ◽  
Sousan Kolahi ◽  
Vahideh Ebrahimzadeh Attari ◽  
Aida Malek Mahdavi
Keyword(s):  
Placebo Group ◽  
Knee Osteoarthritis ◽  
Global Assessment ◽  
Intervention Group ◽  
Controlled Study ◽  
Carnitine Supplementation ◽  
Double Blind ◽  
Necrosis Factor Alpha ◽  
Matrix Metalloproteinase 3 ◽  
Significant Difference

<p class="Abstract">Seventy-two females with mild to moderate knee osteoarthritis were included in this randomized double-blind placebo-controlled study. Patients in the intervention group (n=36) received L-carnitine supplement (750 mg/day) for two months. L-Carnitine supplementation led to decrease in serum TNF-α and MMP-3 levels significantly in comparison with the baseline (p&lt;0.001 and p&lt;0.001, respectively) and placebo group (p&lt;0.001 and p=0.03, respectively). In addition, physician’s global assessment of the severity of osteoarthritis decreased significantly in the L-carnitine group (p&lt;0.001) and placebo group (p=0.012) after supplementation. At the end of the study, a significant difference was observed between the two groups for mean physician’s global assessment of the severity of osteoarthritis (p&lt;0.001), adjusted for baseline values and duration of osteoarthritis. L-Carnitine supplementation has beneficial effects in reducing inflammatory biomarkers in knee osteoarthritis patients which subsequently leads to the alleviation of disease symptoms.</p>

scholarly journals Effects of Intravenous Lidocaine on Alfentanil Consumption During Procedural Sedation for Colonoscopy in Patients With Inflammatory Bowel Disease: a Randomized Controlled Trial

2020 ◽  
Author(s):  
Twan Aalbers ◽  
Sandra A.S. van den Heuvel ◽  
Ewald M. Bronkhorst ◽  
Aura A.J. van Esch ◽  
Gert Jan Scheffer ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Primary Objective ◽  
Procedural Sedation ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Lidocaine Group ◽  
Sedation And Analgesia ◽  
Inflammatory Bowel

Abstract Background: Procedural sedation and analgesia (PSA) is used during colonoscopy to facilitate the procedure and relieve patient’s discomfort. The foremost risk of PSA is respiratory depression. Lidocaine could be a promising additional analgesic in IBD patients to minimise side effects of PSA.Our primary objective was to investigate whether i.v. lidocaine reduces the amount of alfentanil used during PSA in IBD patients. Additionally, we investigated whether lidocaine reduces cardiorespiratory incidents and the amount of propofol required during the procedure.Methods: A randomised, double-blind, placebo controlled study was performed at the endoscopy unit of the Radboud University Medical Centre from November 2016 to December 2018. Seventy-six patients with IBD, ASA 1 or 2, between 18 and 65 years, scheduled for colonoscopy with PSA were included. Patients received lidocaine 1.5 mg kg-1 followed by a continuous infusion of 2 mg kg-1 h-1 (intervention group, n=38) or 0.9% saline in equivalent volumes (control group, n=38) during colonoscopy.Results: There was a reduction in the use of alfentanil (327µg (95%CI=-31-505, p=0.082)), and propofol (39 mg (95%CI=-5-83, p=0.083)) in the lidocaine group compared with the control group. Ten patients (26%) in the control group and 8 patients in the lidocaine group (21%) experienced a period of hypoxia (p=0.788). In both groups, no periods of hypotension were noted.Conclusion: Our investigation has shown a reduction in the use of propofol and alfentanil in patients undergoing colonoscopy with PSA. The differences were not statistically significant. Lidocaine did not reduces the incidence of cardiorespiratory events.Trial registration:EudraCT, 2016-002210-46, registered 19 may 2016,https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-002210-46/resultsISRCTN, ISRCTN47787339, retrospectively registered 6 February 2019, http://www.isrctn.com/ISRCTN47787339

scholarly journals Effects of a Brief Behavioral Training Program on Sleep Quality in Older Adults With Moderate Sleep Disturbances

2020 ◽  
Vol 9 (1) ◽  
pp. 7-13
Author(s):  
Maryam Eshghizadeh ◽  
Mahboubeh Esmaeili ◽  
Shahnaz Ahrari
Keyword(s):  
Older Adults ◽  
Sleep Quality ◽  
Training Program ◽  
Sleep Disturbances ◽  
Adult Population ◽  
Intervention Group ◽  
Control Group ◽  
Behavioral Training ◽  
Post Intervention ◽  
Subjective Sleep Quality

Background: Sleep disturbances are very common among elderly population and mostly remain incurable. Practical, brief, and effective interventions are needed to promote sleep quality in older adults with moderate sleep disturbances. This study aimed to investigate the effectiveness of a brief behavioral training program in ameliorating sleep quality in older adults suffering from moderate sleep disturbances. Materials and Methods: This study was conducted on 64 older adults with moderate sleep disturbances, as defined by Pittsburgh Sleep Quality Index (PSQI) score ≥5. Participants were randomly allocated to either intervention (n=32) or control (n=32) group. Older adults in the intervention group received a brief behavioral-based sleep training program which was delivered in a single in-person session followed by four telephone sessions during 4 weeks. While their peers in the control group did not receive any intervention. The main outcome of the study was scores on the PSQI which was compared at pre- and post-intervention between both groups. Data were analyzed using the SPSS software version 19.0. Results: At 4 weeks, PSQI scores decreased in older adults receiving intervention, as compared with the scores of participants to the control group (P<0.001). Subjects in the intervention group also showed significant improvements in sleep latency, subjective sleep quality, sleep duration, and sleep efficiency (P<0.05). Conclusion: Brief behavioral interventions may be promising and useful for older adult population with moderate problems, and can be considered an efficacious and non-invasive intervention approach to improve elderly’s sleep quality.

Influence of Simvastatin as Augmentative Therapy in the Treatment of Generalized Anxiety Disorder: A Pilot Randomized, Placebo-Controlled Study

2020 ◽  
pp. 1-11
Author(s):  
Ehsan Mirzaei ◽  
Mahtabalsadat Mirjalili ◽  
Leila Jahangard ◽  
Mohammad Haghighi ◽  
Fatemeh Yasrebifar ◽  
...  
Keyword(s):  
Placebo Group ◽  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Intervention Group ◽  
Density Lipoprotein ◽  
Controlled Study ◽  
Control Group ◽  
Generalized Anxiety ◽  
Potential Efficacy ◽  
Over Time

<b><i>Background:</i></b> Preliminary evidence is promising regarding the anxiolytic effects of statins in animal models of anxiety. Hence, this study aimed to evaluate the efficacy of simvastatin augmentation versus placebo in the treatment of patients with generalized anxiety disorder (GAD) with residual symptoms despite treatment with selective serotonin reuptake inhibitors (SSRIs). <b><i>Methods:</i></b> A double-blind, 8-week controlled trial was conducted from August 2018 to December 2019 in an outpatient psychiatry clinic in Hamadan, Iran. A total of 138 patients with a diagnosis of GAD were assessed for eligibility. Of them, 84 patients who met the study criteria were randomly assigned either to the adjuvant simvastatin (20 mg/day) or to the placebo group. Standard medication consisting of SSRIs was consistent 2 months prior to and during the study. The severity of anxiety symptoms for each patient was assessed based on the Hamilton Anxiety Rating Scale (HAM-A) score at baseline, week 4, and week 8 after treatment. Additionally, blood lipid values were assessed at baseline and on completion of the study. <b><i>Results:</i></b> Thirty-three out of 42 patients in the intervention group and 35 out of 42 patients in the control group completed the 8 weeks of the study period. Compared to the placebo group, in the simvastatin group cholesterol, triglycerides, and low-density lipoprotein significantly decreased, and high-density lipoprotein significantly increased over time. General linear model analysis demonstrated that although over time a higher decrease in mean HAM-A scores was observed in the intervention group compared to the control group, this difference was not statistically significant (<i>p</i> = 0.11). In addition, at the end of the study, the number of responders and remitters was comparable in the two groups. <b><i>Conclusions:</i></b> The results from this clinical study did not support the potential efficacy of adjunctive simvastatin in the treatment of patients with GAD. Thus, large-scale and long-term clinical trials are required to more accurately assess the potential efficacy of statins in the treatment of patients with anxiety disorders.

Effects of Astaxanthin Supplementation on Lipid Peroxidation

2007 ◽  
Vol 77 (1) ◽  
pp. 3-11 ◽  
Author(s):  
Karppi ◽  
Rissanen ◽  
Nyyssönen ◽  
Kaikkonen ◽  
Olsson ◽  
...  
Keyword(s):  
Lipid Peroxidation ◽  
Fatty Acids ◽  
Placebo Group ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind Study ◽  
Carotenoid Pigment ◽  
Double Blind

Astaxanthin, the main carotenoid pigment in aquatic animals, has greater antioxidant activity in vitro (protecting against lipid peroxidation) and a more polar configuration than other carotenoids. We investigated the effect of three-month astaxanthin supplementation on lipid peroxidation in healthy non-smoking Finnish men, aged 19–33 years by using a randomized double-blind study design. Also absorption of astaxanthin from capsules into bloodstream and its safety were evaluated. The intervention group received two 4-mg astaxanthin (Astaxin®) capsules daily, and the control group two identical-looking placebo capsules. Astaxanthin supplementation elevated plasma astaxanthin levels to 0.032 μmol/L (p < 0.001 for the change compared with the placebo group). We observed that levels of plasma 12- and 15-hydroxy fatty acids were reduced statistically significantly in the astaxanthin group (p = 0.048 and p = 0.047 respectively) during supplementation, but not in the placebo group and the change of 15-hydroxy fatty acid was almost significantly greater (p = 0.056) in the astaxanthin group, as compared with the placebo group. The present study suggests that intestinal absorption of astaxanthin delivered as capsules is adequate, and well tolerated. Supplementation with astaxanthin may decrease in vivo oxidation of fatty acids in healthy men.

scholarly journals Clinical Efficacy of Traditional Chinese Medicine, Suan Zao Ren Tang, for Sleep Disturbance during Methadone Maintenance: A Randomized, Double-Blind, Placebo-Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Yuan-Yu Chan ◽  
Yi-Hung Chen ◽  
Szu-Nian Yang ◽  
Wan-Yu Lo ◽  
Jaung-Geng Lin
Keyword(s):  
Sleep Quality ◽  
Sleep Disturbances ◽  
Methadone Maintenance ◽  
Controlled Trial ◽  
Intervention Group ◽  
Placebo Treatment ◽  
Sleep Efficiency ◽  
Opiate Dependence ◽  
Double Blind ◽  
Sleep Complaints

Methadone maintenance therapy is an effective treatment for opiate dependence, but more than three-quarters of persons receiving the treatment report sleep quality disturbances. In this double-blind, randomized, controlled trial, we recruited 90 individuals receiving methadone for at least one month who reported sleep disturbances and had Pittsburgh Sleep Quality Index (PSQI) scores > 5. The purpose of this study was to determine whether Suan Zao Ren Tang, one of the most commonly prescribed traditional Chinese medications for treatment of insomnia, improves subjective sleep among methadone-maintained persons with disturbed sleep quality. Ninety patients were randomly assigned to intervention group (n=45) and placebo group (n=45), and all participants were analyzed. Compared with placebo treatment, Suan Zao Ren Tang treatment for four weeks produced a statistically significant improvement in the mean total PSQI scores (P=0.007) and average sleep efficiency (P=0.017). All adverse events (e.g., lethargy, diarrhea, and dizziness) were mild in severity. Suan Zao Ren Tang is effective for improving sleep quality and sleep efficiency among methadone-maintained patients with sleep complaints.

scholarly journals Effects of Cinnamon on Anthropometry Status and Headache Disability of Migraine Patients: A Randomized Double-blind Placebo-controlled Trial

2020 ◽  
Author(s):  
Azadeh Zareie ◽  
Mohammad Bagherniya ◽  
Manoj Sharma ◽  
Fariborz Khorvash ◽  
Akbar Hasanzadeh ◽  
...  
Keyword(s):  
Placebo Group ◽  
Corn Starch ◽  
Controlled Trial ◽  
Intervention Group ◽  
Primary Headache ◽  
Control Group ◽  
Double Blind ◽  
Beneficial Effects ◽  
The Difference ◽  
Headache Disability

Abstract Background: Migraine is a common type of primary headache that is highly disabling and is possibly associated with obesity. Increasing body mass index (BMI) seems to be a risk factor for migraine attacks. Cinnamon has anti-inflammatory, neuroprotective, and anti-obesity effects. Thus, this study aimed to assess the effects of cinnamon on anthropometry status and headache disability of migraine patients.Methods: Fifty patients with migraine were randomized to receive either cinnamon powder, three capsules/day each containing 600 mg of cinnamon or three placebo capsules/day each containing 100 mg of corn starch (control group) for two months. Height, body weight (BW), waist circumference (WC), and hip circumference (HC) were measured at baseline and the end of the study. Furthermore, Minimal or Infrequent Disability (MIDAS) and Headache Daily Result (HDR) Questionnaire were recorded. Results: After follow-up, BW and BMI did not change in the intervention group, however, both of them significantly increased in the placebo group. The differences between the two groups were statistically significant (p=0.001). WC significantly decreased in the cinnamon group and remarkably increased in the control group; the difference between groups was significant (p<0.001). Furthermore, HC and WHR significantly decreased in the intervention group than the placebo group (p=0.001). HDR and the total score of disability in migraine patients were significantly decreased in the intervention versus the control group (p<0.001). Conclusion: Cinnamon seems to have beneficial effects on BW, BMI, WC, and HC and it reduces the headache disability of migraine patients. More randomized controlled trials should be undertaken to confirm these effects.

THE EFFECTIVENESS OF MICRONUTRIENT SUPPLEMENTATION ON ZINC DEFICIENCY, VITAMIN A DEFICIENCY AMONG ADOLESCENT GIRLS IN MOUNTAINOUS HIGH SCHOOL IN THANH HOA PROVINCE IN 2019 - 2020

2021 ◽  
Vol 62 (6) ◽  
Author(s):  
Luu Kim Le Hang ◽  
Tran Thuy Nga ◽  
Nguyen Thi Lan Phuong ◽  
Nguyen Xuan Hiep
Keyword(s):  
High School ◽  
Placebo Group ◽  
Vitamin A ◽  
Zinc Deficiency ◽  
Adolescent Girls ◽  
Vitamin A Deficiency ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Significant Difference

A community intervention study with a placebo group, double-blind, evaluating the effect of using multi-micronutrient tablets on zinc deficiency, vitamin A deficiency among adolescent girls in mountainous high school in Thanh Hoa province in 2019 - 2020, using WHO and IZiNCG classifications. A double-blind randomized controlled trial was conducted among 322 school girls randomly divided into 2 groups. The multi-micronutrient supplements consist of 23 vitamins and minerals, including zinc (10.8 mg), vitamin A (550mcg), while the placebo group took a placebo tablet, once a week for 9 months. All of the children were dewormed by Albendazole 400 mg at baseline. Results showed that after 9 months of intervention, the mean serum zinc concentration of the intervention group (11.35 ± 2.88 µmol/l) was significantly improved and significantly higher than that of the Control group (10.51 ± 2.08 µmol/l) with p<0.05. The retinol concentration did not show significant difference between the two groups, but there was a significant improvement compared to the baseline time the intervention group with an increase level of 0.07 ± 0.30 mol. /l. After the intervention, the rate of zinc deficiency, sub-clinical vitamin A deficiency was not statistically significant between the two groups.

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