scholarly journals Night Vision and Carotenoids (NVC): A Randomized Placebo Controlled Clinical Trial on Effects of Carotenoid Supplementation on Night Vision in Older Adults

Nutrients ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 3191
Author(s):  
Stuart Richer ◽  
Steven Novil ◽  
Taylor Gullett ◽  
Avni Dervishi ◽  
Sherwin Nassiri ◽  
...  
Keyword(s):  
Placebo Group ◽  
Risk Score ◽  
Divided Attention ◽  
Small Sample ◽  
Night Vision ◽  
Risk Scores ◽  
Crash Risk ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Carotenoid Supplementation

Twilight and low luminance levels are visually challenging environments for the elderly, especially when driving at night. Carotenoid rich diets are known to increase macular pigment optical density (MPOD), which in turn leads to an improvement in visual function. It is not known whether augmenting MPOD can lead to a decrease in vision related night driving difficulties. Additionally, it is unknown if carotenoid supplementation provides additional measurable benefits to one’s useful field of view (UFOV) along with a decreased composite crash risk score. The aim of the study was to evaluate changes in night vision function and UFOV in individuals that took carotenoid vitamin supplements for a six-month period compared to a placebo group. Methods: A prospective, randomized, double-blind, six-month trial of a 14 mg zeaxanthin/7 mg lutein-based supplement was carried out. Participants were randomized into active or placebo group (approx 2:1). Results: n = 33 participants (26 males/7 females) participated with 93% capsule intake compliance in the supplemented group (n = 24) and placebo group (n = 9). MPOD (mean/standard error SE) in the active group increased in the Right eye from 0.35 density units (du)/0.04 SE to 0.41 du/0.05 SE; p < 0.001 and in the Left eye from 0.35 du/0.05 SE to 0.37 du, p > 0.05). The supplemented group showed significant improvements in contrast sensitivity with glare in both eyes with improvements in LogMAR scores of 0.147 and 0.149, respectively (p = 0.02 and 0.01, respectively), monocularly tested glare recovery time improved 2.76 and 2.54 s, respectively, (p = 0.008 and p = 0.02), and we also noted a decreased preferred luminance required to complete visual tasks (p = 0.02 and 0.03). Improvements in UFOV scores of divided attention (p < 0.001) and improved composite crash risk score (p = 0.004) were seen in the supplemented group. The placebo group remained unchanged. Conclusions: The NVC demonstrates that augmenting MPOD in individuals with difficulty in night vision showed measurable benefits in numerous visual functions that are important for night vision driving in this small sample RCT. Additionally, we observed an improvement in UFOV divided attention test scores and decreased composite risk scores.

scholarly journals The Effects of Propolis Extract Administration on HIV Patients Receiving ARV

2021 ◽  
Vol 13 (1) ◽  
pp. 75-83
Author(s):  
Erwin Astha Triyono ◽  
Sarah Firdausa ◽  
Heru Prasetyo ◽  
Joni Susanto ◽  
James Hutagalung ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Clinical Symptoms ◽  
Cd4 Count ◽  
Controlled Clinical Trial ◽  
Human Immune System ◽  
Hiv Patients ◽  
Double Blind ◽  
Significant Difference

BACKGROUND: Human immunodeficiency virus (HIV) is an infectious disease that targets the human immune system by attacking cluster of differentiation (CD)4 cells. The use of propolis in HIV patients is expected to be safe and beneficial in terms of increasing endurance and immunity by its role in increasing CD4 level. This study aimed to analyze the influence of propolis supplementation in increasing the CD4 level in anti-retroviral (ARV)-treated HIV patients.METHODS: Double-blind randomized controlled clinical trial was conducted in 50 HIV patients who took regular ARV therapy. The subjects were divided into two groups, one group was treated with ARV and propolis, while another one was given ARV and placebo. The CD4 cell count was measured during pre-treatment, in the 3rd month, in the 6th month after treatment. The level of hemoglobin, leukocyte, and platelets were also measured. The SF-12 questionnaire was used to evaluate quality of life of the subject.RESULTS: Out of 50 subjects, 43 subjects completed the study, which were 19 subjects from the propolis group and 24 subjects from the placebo group. After 3-month of treatment, there was a statistically significant difference in the incrwase of CD 44 level in propolis group, while the increment was not significant in the placebo group. After 6-month treatment, the increase of CD4 level was occurred in both groups, propolis and placebo, however the increment was not statistically significant. The levels of hemoglobin, leukocyte, and platelets were not altered by the treatment and remained normal throughout the study. The quality of life was improved during the study; however, it was also not statistically significant. Mild adverse events occurred in 3 subjects which were relieved after the treatment stopped.CONCLUSION: Based on the result of this study, the administration of propolis on HIV patients receiving ARV bring significant difference in the increase of CD4 in propolis group from baseline to 3 month after the treatment. While in placebo group, this increment was not significant. At the end of study, CD4 count continued to rise up, however the increase was not statistically significant. There are no hemoglobin, leukocyte, platelets, and quality of life abnormalities. Therefore, it is necesary to do further research with a spesific CD4 count. However, it may be beneficial in relieving the clinical symptoms and quality of life of patient living with HIV.KEYWORDS: CD4, ARV, HIV, propolis

scholarly journals Effects of Lactobacillus plantarum and Lactobacillus paracasei on the Peripheral Immune Response in Children with Celiac Disease Autoimmunity: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Nutrients ◽  
2019 ◽  
Vol 11 (8) ◽  
pp. 1925 ◽  
Author(s):  
Åsa Håkansson ◽  
Carin Andrén Aronsson ◽  
Charlotte Brundin ◽  
Elin Oscarsson ◽  
Göran Molin ◽  
...  
Keyword(s):  
Immune Response ◽  
Celiac Disease ◽  
Placebo Group ◽  
Inflammatory Responses ◽  
Tissue Transglutaminase ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Th Cells ◽  
Double Blind Placebo ◽  
Peripheral Immune Response

Two Lactobacillus strains have proven anti-inflammatory properties by reducing pro-inflammatory responses to antigens. This randomized double-blind placebo-controlled trial tested the hypothesis that L. plantarum HEAL9 and L. paracasei 8700:2 suppress ongoing celiac disease autoimmunity in genetically at risk children on a gluten-containing diet in a longitudinally screening study for celiac disease. Seventy-eight children with celiac disease autoimmunity participated of whom 40 received 1010 CFU/day of L. plantarum HEAL9 and L. paracasei 8700:2 (probiotic group) and 38 children maltodextrin (placebo group) for six months. Blood samples were drawn at zero, three and six months and phenotyping of peripheral blood lymphocytes and IgA and IgG autoantibodies against tissue transglutaminase (tTG) were measured. In the placebo group, naïve CD45RA+ Th cells decreased (p = 0.002) whereas effector and memory CD45RO+ Th cells increased (p = 0.003). In contrast, populations of cells expressing CD4+CD25highCD45RO+CCR4+ increased in the placebo group (p = 0.001). Changes between the groups were observed for NK cells (p = 0.038) and NKT cells (p = 0.008). Median levels of IgA-tTG decreased more significantly over time in the probiotic (p = 0.013) than in the placebo (p = 0.043) group whereas the opposite was true for IgG-tTG (p = 0.062 respective p = 0.008). In conclusion, daily oral administration of L. plantarum HEAL9 and L. paracasei 8700:2 modulate the peripheral immune response in children with celiac disease autoimmunity.

OscillococcinumR in patients with influenza-like syndromes: A placebo-controlled double-blind evaluation

1998 ◽  
Vol 87 (02) ◽  
pp. 69-76 ◽  
Author(s):  
Rosemarie Papp ◽  
Gert Schuback ◽  
Elmar Beck ◽  
Georg Burkard ◽  
Jürgen Bengel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Rectal Temperature ◽  
Muscle Pain ◽  
Rating Scale ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Duration Of Symptoms ◽  
Number Of Patients ◽  
Positive Effect

AbstractA controlled clinical trial was conducted to assess the effectiveness of OscillococcinumR in the treatment of patients with influenza-like syndromes. 188 patients received the test drug and 184 patients were assigned to the placebo. Data were recorded by the participating physicians at the beginning of the treatment, after 48 hours and after 7–10 days. During the first few days, the patients recorded their rectal temperature twice a day (mornings and evenings), 9 symptoms on a rating scale (cough, catarrh, sore throat, muscle pain, etc.), and use of medication. Recovery was defined as follows: ‘rectal temperature < 37.5°C and no headache or muscle pain’. Effectiveness was defined as a statistically significant greater decrease in symptoms after 48 hours in the verum group or a shorter duration of symptoms in comparison to the placebo group. After 48 hours the symptoms of the patients in the verum group were significantly milder (P=0.023) than in the placebo group. The number of patients with no symptoms was significantly higher in the verum group from the second day onwards (verum: 17.4%, placebo: 6.6%) until the end of the patients’ recording (day 5 in the evening: verum: 73.7%, placebo: 67.7%). The biggest group difference was recorded for the time between the evening of the second day (10.6% more patients with no symptoms) and the morning of the fourth day (10.2% more patients with no symptoms). The clinical trial showed that treatment of influenza-like syndromes with OscillococcinumR has a positive effect on the decline of symptoms and on the duration of the disease.

scholarly journals Effect of Phytosomal Curcumin on Circulating Levels of Adiponectin and Leptin in Patients with Non-Alcoholic Fatty Liver Disease: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2019 ◽  
Vol 28 ◽  
pp. 183-189 ◽  
Author(s):  
Seyed Reza Mirhafez ◽  
Azam Rezaei Farimani ◽  
Maryam Dehhabe ◽  
Mohammad Bidkhori ◽  
Mitra Hariri ◽  
...  
Keyword(s):  
Placebo Group ◽  
Liver Disease ◽  
Fatty Liver ◽  
Fatty Liver Disease ◽  
Serum Adiponectin ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Alcoholic Fatty Liver ◽  
Double Blind Placebo ◽  
Alcoholic Fatty Liver Disease

Background & Aims: Non-alcoholic fatty liver disease (NAFLD) is associated with insulin resistance and changes in serum adipocytokine levels. The aim of the current study was to evaluate the effect of phytosomal curcumin on serum adiponectin and leptin levels in patients with NAFLD. Methods: In this randomized double-blind, placebo-controlled trial, 65 eligible patients were randomly allocated into curcumin and placebo recipient groups using a blocked randomized technique. Parameters of weight, height, body mass index (BMI), fasting blood sugar (FBS), lipid profile, aspartate aminotransferase (AST), alanine aminotransferase (ALT), adiponectin, leptin, and the leptin:adiponectin ratio were measured at baseline and eight weeks after intervention. Results: High-density lipoprotein cholesterol (HDL-C) levels increased significantly in the curcumin group compared to the placebo group (p=0.01). Serum adiponectin levels increased significantly (p<0.001) and serum leptin levels decreased significantly (p<0.001) with a decrease in the leptin: adiponectin ratio in the curcumin group compared to the placebo group after 8 weeks of intervention. Conclusions: Non-alcoholic fatty liver disease was associated with changes in serum adipokines levels. Phytosomal curcumin effectively improved leptin and adiponectin levels. It is possible that curcumin efficacy will increase with long-term use of higher doses of this substance.

scholarly journals Ingestion of a THC-Rich Cannabis Oil in People with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Pain Medicine ◽  
2020 ◽  
Vol 21 (10) ◽  
pp. 2212-2218
Author(s):  
Carolina Chaves ◽  
Paulo Cesar T Bittencourt ◽  
Andreia Pelegrini
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Placebo Group ◽  
Low Cost ◽  
Fibromyalgia Impact Questionnaire ◽  
Health Condition ◽  
Depression Score ◽  
Controlled Clinical Trial ◽  
Double Blind

Abstract Objective To determine the benefit of a tetrahydrocannabinol (THC)-rich cannabis oil on symptoms and quality of life of fibromyalgia patients. Methods A double-blind, randomized, placebo-controlled clinical trial was conducted for eight weeks to determine the benefit of a THC-rich cannabis oil (24.44 mg/mL of THC and 0.51 mg/mL of cannabidiol [CBD]) on symptoms and quality of life of 17 women with fibromyalgia, residents of a neighborhood with a low socioeconomic profile and a high incidence of violence in the city of Florianopolis, Brazil. The initial dose was one drop (∼1.22 mg of THC and 0.02 mg of CBD) a day with subsequent increases according to symptoms. The Fibromyalgia Impact Questionnaire (FIQ) was applied at pre- and postintervention moments and in five visits over eight weeks. Results There were no significant differences on baseline FIQ score between groups. However, after the intervention, the cannabis group presented a significant decrease in FIQ score in comparison with the placebo group (P = 0.005) and in comparison with cannabis group baseline score. (P &lt; 0.001). Analyzing isolated items on the FIQ, the cannabis group presented significant improvement on the “feel good,” “pain,” “do work,” and “fatigue” scores. The placebo group presented significant improvement on the “depression” score after intervention. There were no intolerable adverse effects. Conclusions Phytocannabinoids can be a low-cost and well-tolerated therapy to reduce symptoms and increase the quality of life of patients with fibromyalgia. Future studies are still needed to assess long-term benefits, and studies with different varieties of cannabinoids associated with a washout period must be done to enhance our knowledge of cannabis action in this health condition.

Evaluation of a nutritional supplement for the alleviation of pain associated with feline degenerative joint disease: a prospective, randomized, stratified, double-blind, placebo-controlled clinical trial

2021 ◽  
pp. 1098612X2110534
Author(s):  
Rachael Cunningham ◽  
Margaret E Gruen ◽  
Andrea Thomson ◽  
B Duncan X Lascelles
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Chondroitin Sulfate ◽  
Outcome Measures ◽  
Nutritional Supplement ◽  
Degenerative Joint Disease ◽  
Joint Disease ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo

Objectives The purpose of this study was to evaluate the pain-alleviating and activity-enhancing effects of glucosamine/chondroitin sulfate (Dasuquin) in cats that had degenerative joint disease (DJD) and owner-noted mobility/activity impairment. We hypothesized that the nutritional supplement would produce pain-relieving and activity-enhancing effects in cats with painful DJD. Methods In this prospective, randomized, stratified, double-blind, placebo-controlled clinical trial, 59 cats with DJD pain were assigned to receive a placebo (n = 30) or supplement (n = 29) for 6 weeks after 2 weeks of placebo. Outcome measures (at-home accelerometry and client-specific outcome measures [feline (CSOMf); Feline Musculoskeletal Pain Index (FMPI); quality of life (QoL)]; and veterinarian examination) were collected at days 14, 28, 42 and 56. Results Twenty-seven cats in the treatment group and 30 in the placebo group completed the trial. Within the first 2 weeks (placebo administration to all cats), 78% of all cats had an improvement in CSOMf scores. Both groups showed significant improvement at most time points in CSOMf, FMPI, QoL and pain scores, with the placebo group showing greater improvement than the supplement group (significant for CSOMf [ P = 0.01]). Overall, no differences in activity were seen between the groups. Cumulative distribution function analysis indicated that for most levels of activity, the placebo-treated cats were more active; however, the least active cats were more active on the supplement ( P = 0.013). Conclusions and relevance This study showed a strong placebo effect. The glucosamine/chondroitin sulfate supplement did not show pain-relieving effects when compared with placebo.

scholarly journals A Clinical Trial to Investigate the Effect of Cynatine HNS on Hair and Nail Parameters

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Christina Beer ◽  
Simon Wood ◽  
Robert H. Veghte
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Amino Acid ◽  
Hair Loss ◽  
Hair Growth ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
End Points ◽  
Double Blind Placebo ◽  
New Novel

Objective. A new, novel product, Cynatine HNS, was evaluated for its effects as a supplement for improving various aspects of hair and nails in a randomized, double-blind, placebo-controlled clinical trial.Methods. A total of 50 females were included and randomized into two groups. The active group (n=25) received 2 capsules containing Cynatine HNS, comprised of Cynatine brand keratin (500 mg) plus vitamins and minerals, per day, and the placebo group (n=25) received 2 identical capsules of maltodextrin per day for 90 days. End points for hair loss, hair growth, hair strength, amino acid composition, and hair luster were measured. End points were also measured for nail strength and the appearance of nails.Results. The results show that subjects taking Cynatine HNS showed statistically significant improvements in their hair and nails when compared to placebo.Conclusion. Cynatine HNS is an effective supplement for improving hair and nails in 90 days or less. EudraCT number is 2014-002645-22.

scholarly journals Effectiveness and Safety of Panax ginseng Extract on Hepatic Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Lei Shen ◽  
Si Ra Gwak ◽  
Jong Cheon Joo ◽  
Bong Keun Song ◽  
Seon Woo Cha ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Panax Ginseng ◽  
Hepatic Dysfunction ◽  
Controlled Clinical Trial ◽  
Gamma Glutamyl Transferase ◽  
Double Blind ◽  
Ginseng Extract ◽  
Double Blind Placebo ◽  
Glutamyl Transferase

Background. The purpose of this study was to evaluate the efficacy and safety of Panax ginseng extract (GS-KG9) in the treatment of hepatic dysfunction. Methods. A randomized, double-blind, placebo-controlled clinical trial was conducted from December 2017 to January 2019. The trial included 60 subjects between the ages of 19 and 70 who had higher alanine transaminase (ALT) levels than the normal upper limit. The subjects were randomly divided into two groups: GS-KG9 (n = 30) and placebo (n = 30). The former was administered three GS-KG9 capsules (3 g/day) and the latter three placebo capsules (3 g/day) twice each day orally after meals in the morning and evening for 12 weeks. The primary goal was to observe the changes in ALT and gamma-glutamyl transferase (GGT) levels. The safety of the treatment was assessed and adverse events (AEs) were recorded. Results. Out of 60 subjects, nine were excluded from the efficacy analysis because they met the exclusion criteria. Therefore, a total of 51 subjects were evaluated for the effectiveness of the treatment (26 in the GS-KG9 group and 25 in the placebo group). After 12 weeks of treatment, the ALT levels were significantly reduced in the GS-KG9 group compared to the placebo group (p=0.009). The GGT level of the GS-KG9 group was significantly lower than that of the placebo group (p=0.036). Mild AEs, such as diarrhea, occurred during the study. There were no significant differences between the two groups. Conclusion. The results of this trial suggest that GS-KG9 might be an effective and safe option for mild hepatic dysfunction. This trial is registered with KCT0004080.

scholarly journals The Effect of Dietary Supplementation of Crocetin for Myopia Control in Children: A Randomized Clinical Trial

2019 ◽  
Vol 8 (8) ◽  
pp. 1179 ◽  
Author(s):  
Kiwako Mori ◽  
Hidemasa Torii ◽  
Satoko Fujimoto ◽  
Xiaoyan Jiang ◽  
Shin-ichi Ikeda ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Large Scale ◽  
Suppressive Effect ◽  
Institutional Review Boards ◽  
Controlled Clinical Trial ◽  
Myopia Progression ◽  
Double Blind ◽  
Institutional Review ◽  
To Receive

The prevalence of myopia has been increasing in recent years. The natural carotenoid crocetin has been reported to suppress experimental myopia in mice. We evaluated the effects of crocetin on myopia suppression in children. A multicenter randomized double-blind placebo-controlled clinical trial was performed with 69 participants aged 6 to 12 years, whose cycloplegic spherical equivalent refractions (SER) were between −1.5 and −4.5 diopter (D). The participants were randomized to receive either a placebo or crocetin and followed up for 24 weeks. Axial length (AL) elongation and changes in SER were evaluated for 24 weeks. Both written informed assent from the participants and written informed consent from legal guardians were obtained in this study because the selection criteria of this trial included children aged between 6 and 12 years old. This trial was approved by the institutional review boards. A mixed-effects model was used for analysis, using both eyes. Two participants dropped out and 67 children completed this trial. The change in SER in the placebo group, −0.41 ± 0.05 D (mean ± standard deviation), was significantly more myopic compared to that in the crocetin group, −0.33 ± 0.05 D (p = 0.049). The AL elongation in the placebo group, 0.21 ± 0.02 mm, was significantly bigger than that in the crocetin group, 0.18 ± 0.02 mm (p = 0.046). In conclusion, dietary crocetin may have a suppressive effect on myopia progression in children, but large-scale studies are required in order to confirm this effect.

scholarly journals Lactobacillus reuteri DSM 17938 and Agave Inulin in Children with Cerebral Palsy and Chronic Constipation: A Double-Blind Randomized Placebo Controlled Clinical Trial

Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 2971
Author(s):  
Andrea García Contreras ◽  
Edgar Vásquez Garibay ◽  
Carmen Sánchez Ramírez ◽  
Mary Fafutis Morris ◽  
Vidal Delgado Rizo
Keyword(s):  
Cerebral Palsy ◽  
Placebo Group ◽  
Chronic Constipation ◽  
Lactobacillus Reuteri ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Probiotic Group ◽  
Fecal Mass ◽  
Children With Cerebral Palsy ◽  
History Of

The main objective was to assess the efficacy of a probiotic (Lactobacillus reuteri DSM 17938), a prebiotic (agave inulin), and a synbiotic on the stool characteristics in children with cerebral palsy and chronic constipation. Thirty-seven children with cerebral palsy and chronic constipation were included. The probiotic group received 1 × 108 colony forming unit (cfu) of L. reuteri DSM 17938 plus placebo, the prebiotic group received 4 g of agave inulin plus placebo, the synbiotic group received L. reuteri DSM 17938 plus agave inulin, and the placebo group received two placebos for 28 days. The probiotic group showed a significant decrease in stool pH (p = 0.014). Stool consistency improved in the prebiotic group (p = 0.008). The probiotic, prebiotic, and synbiotic groups showed a significant improvement in the history of excessive stool retention, the presence of fecal mass in the rectum, and the history of painful defecation. L. reuteri concentration in feces was higher in the probiotic group than in the placebo group (p = 0.001) and showed an inverse correlation with stool pH in the probiotic group (r = −0.762, p = 0.028). This study showed that the use of L. reuteri DSM 17938 and/or agave inulin improved the stool characteristics such as the history of painful defecation and the presence of fecal mass in the rectum against placebo in children with cerebral palsy and chronic constipation.

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