scholarly journals Improving Mental Performance in an Athletic Population with the Use of Ārepa®, a Blackcurrant Based Nootropic Drink: A Randomized Control Trial

Antioxidants ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. 316
Author(s):  
Natalie Gibson ◽  
Dane Baker ◽  
Alice Sharples ◽  
Andrea Braakhuis
Keyword(s):  
Controlled Trial ◽  
Training Session ◽  
Rugby League ◽  
Pine Bark ◽  
Post Intervention ◽  
Double Blind ◽  
Dietary Polyphenols ◽  
Bioactive Ingredients ◽  
Post Trial ◽  
And Control

A range of dietary bioactive ingredients have claimed to improve mental clarity and reduce fatigue, including blackcurrant, pine bark, and l-theanine. These active ingredients provide a good source of dietary polyphenols which could be useful in reducing mental fatigue in a sports setting. The aim of the investigation was to test the effect of Ārepa® a blackcurrant-based nootropic-drink also containing pine-bark and l-theanine (BC+), on mental clarity in a sport setting. Twenty-three rugby league players completed a cross-over design, randomized, double-blind, controlled trial. Intervention and control phases lasted 7 days, with a washout in between. Cognition was assessed pre and post intervention following a standardized training session. Our study found the total score, accuracy, and average time per response scores improved significantly more after drinking the BC+ drink (p = 0.001, 0.003, and 0.043 respectively). The BC+ improved the perception that participants were reliable (p = 0.02) and less distracted (p = 0.03), while placebo supplementation increased participant perception they could control their nervousness (p = 0.03). Thematic analysis of post-trial questionnaire indicated participants found the BC+ sour, most reported no side effects, and opinion on which drink was more effective was not unanimous. The results indicate that the BC+ drink may be useful for athletes.

scholarly journals Resistant starch supplementation increases crypt cell proliferative state in the rectal mucosa of older healthy participants

2020 ◽  
Vol 124 (4) ◽  
pp. 374-385
Author(s):  
Fiona C. Malcomson ◽  
Naomi D. Willis ◽  
Iain McCallum ◽  
Long Xie ◽  
Arthur C. Ouwehand ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cell Cycle ◽  
Resistant Starch ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Rectal Mucosa ◽  
Crypt Cell ◽  
Post Intervention ◽  
Double Blind ◽  
Healthy Participants

AbstractThere is strong evidence that foods containing dietary fibre protect against colorectal cancer, resulting at least in part from its anti-proliferative properties. This study aimed to investigate the effects of supplementation with two non-digestible carbohydrates, resistant starch (RS) and polydextrose (PD), on crypt cell proliferative state (CCPS) in the macroscopically normal rectal mucosa of healthy individuals. We also investigated relationships between expression of regulators of apoptosis and of the cell cycle on markers of CCPS. Seventy-five healthy participants were supplemented with RS and/or PD or placebo for 50 d in a 2 × 2 factorial design in a randomised, double-blind, placebo-controlled trial (the Dietary Intervention, Stem cells and Colorectal Cancer (DISC) Study). CCPS was assessed, and the expression of regulators of the cell cycle and of apoptosis was measured by quantitative PCR in rectal mucosal biopsies. SCFA concentrations were quantified in faecal samples collected pre- and post-intervention. Supplementation with RS increased the total number of mitotic cells within the crypt by 60 % (P = 0·001) compared with placebo. This effect was limited to older participants (aged ≥50 years). No other differences were observed for the treatments with PD or RS as compared with their respective controls. PD did not influence any of the measured variables. RS, however, increased cell proliferation in the crypts of the macroscopically-normal rectum of older adults. Our findings suggest that the effects of RS on CCPS are not only dose, type of RS and health status-specific but are also influenced by age.

scholarly journals Efficacy of a herbal toothpaste on patients with established gingivitis: a randomized controlled trial

2006 ◽  
Vol 20 (2) ◽  
pp. 172-177 ◽  
Author(s):  
Fabiana Ozaki ◽  
Claudio Mendes Pannuti ◽  
Ana Vitória Imbronito ◽  
Wellington Pessotti ◽  
Luciana Saraiva ◽  
...  
Keyword(s):  
Adverse Reactions ◽  
Controlled Trial ◽  
Test Group ◽  
Experimental Period ◽  
Positive Control ◽  
Control Group ◽  
Control Groups ◽  
Double Blind ◽  
Significant Difference ◽  
And Control

The aim of this randomised, double blind controlled trial was to verify the efficacy of a herbal dentifrice on the reduction of plaque and gingivitis. Forty eight volunteers with established gingivitis were randomly assigned to either a test group (herbal dentifrice) or positive control group (dentifrice with triclosan and fluoride). The dentifrices were distributed in plain white tubes by an independent pharmacy, which revealed the contents of each tube only after the experimental period. Plaque and gingivitis assessments were carried out on baseline and after 28 days of product use. All examinations were conducted by the same calibrated investigator. Subjects were instructed to brush their teeth three times daily using their assigned dentifrice for 28 days. There was a significant reduction in plaque levels in both the test and control groups. However, there was no significant difference between the groups. A significant reduction in gingivitis was observed in both groups, although there was no significant difference between them. No adverse reactions were reported. The authors concluded that both dentifrices were effective in reducing plaque and gingivitis in subjects with established gingivitis.

scholarly journals Ganji Formulation for Patients with Hepatocellular Carcinoma Who Have Undergone Surgery: A Multicenter, Randomized, Double-Blind, Controlled Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-6
Author(s):  
Jing-Hao Zhang ◽  
Chao Zheng ◽  
Xiao-Jun Zhu ◽  
Xin Zhang ◽  
Zhi-Jun Hou ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Treatment Group ◽  
Liver Resection ◽  
Controlled Trial ◽  
Disease Free Survival ◽  
Control Group ◽  
Double Blind ◽  
Local Ablation ◽  
Significant Difference ◽  
And Control

Objective. To ascertain the efficacy and safety of Ganji Formulation (GF) for patients with Hepatocellular carcinoma (HCC) who had undergone surgery. Materials and Methods. A total of 262 HCC patients who had undergone liver resection, local ablation, or transcatheter arterial chemoembolization (TACE) were divided randomly into the treatment group and control group. The former was treated with GF and the later with placebo, both for 6 months. The primary endpoint was overall survival (OS). Second endpoints were disease-free survival (DFS) or time to disease progression (TTP). Results. OS of the treatment group was significantly longer than that of the control group (P < 0.05). Subgroup analysis showed that, for patients who received TACE, the TTP was significantly longer in the treatment group than in the control group (P < 0.05). However, for patients who underwent liver resection or local ablation, there was no significant difference in DFS between the two groups (P > 0.05). Conclusion. GF could improve postoperative cumulative survival and prolong the TTP. This clinical trial number is registered with ChiCTR-IOR-15007349.

scholarly journals A food-based dietary strategy lowers blood pressure in a low socio-economic setting: a randomised study in South Africa

2008 ◽  
Vol 11 (12) ◽  
pp. 1397-1406 ◽  
Author(s):  
Karen E Charlton ◽  
Krisela Steyn ◽  
Naomi S Levitt ◽  
Nasheeta Peer ◽  
Deborah Jonathan ◽  
...  
Keyword(s):  
Blood Pressure ◽  
South African ◽  
Controlled Trial ◽  
Control Diet ◽  
Diet Group ◽  
Post Intervention ◽  
Intervention Effect ◽  
Double Blind ◽  
Cation Content ◽  
The Impact

AbstractObjectiveTo assess the impact of a food-based intervention on blood pressure (BP) in free-living South African men and women aged 50–75 years, with drug-treated mild-to-moderate hypertension.MethodsA double-blind controlled trial was undertaken in eighty drug-treated mild-to-moderate hypertensive subjects randomised to an intervention (n40) or control (n40) arm. The intervention was 8-week provision of six food items with a modified cation content (salt replacement (SOLO™), bread, margarine, stock cubes, soup mix and a flavour enhancer) and 500 ml of maas (fermented milk)/d. The control diet provided the same quantities of the targeted foods but of standard commercial composition and 500 ml/d of artificially sweetened cooldrink.FindingsThe intervention effect estimated as the contrast of the within-diet group changes in BP from baseline to post-intervention was a significant reduction of 6·2 mmHg (95 % CI 0·9, 11·4) for systolic BP. The largest intervention effect in 24 h BP was for wake systolic BP with a reduction of 5·1 mmHg (95 % CI 0·4, 9·9). For wake diastolic BP the reduction was 2·7 mmHg (95 % CI −0·2, 5·6).ConclusionsModification of the cation content of a limited number of commonly consumed foods lowers BP by a clinically significant magnitude in treated South African hypertensive patients of low socio-economic status. The magnitude of BP reduction provides motivation for a public health strategy that could be adopted through lobbying of the food industry by consumer and health agencies.

scholarly journals Rewards can be used effectively with repeated exposure to increase liking of vegetables in 4–6-year-old children

2011 ◽  
Vol 16 (5) ◽  
pp. 942-951 ◽  
Author(s):  
Nadia Corsini ◽  
Amy Slater ◽  
Adam Harrison ◽  
Lucy Cooke ◽  
David N Cox
Keyword(s):  
Vegetable Consumption ◽  
Controlled Trial ◽  
South Australia ◽  
Repeated Exposure ◽  
Control Group ◽  
Post Intervention ◽  
Local Media ◽  
Taste Exposure ◽  
And Control

AbstractObjectiveTo examine whether parents offering a sticker reward to their child to taste a vegetable the child does not currently consume is associated with improvements in children's liking and consumption of the vegetable.DesignA randomized controlled trial evaluated the effectiveness of exposure only (EO) and exposure plus reward (E + R), relative to a control group, on children's liking and consumption of a target vegetable. Assessments were conducted at baseline and 2 weeks from baseline (post-intervention). Follow-up assessments were conducted at 4 weeks and 3 months from baseline.SettingThe study took place in Adelaide, South Australia. Participants were self-selected in response to local media advertisements seeking to recruit parents finding it difficult to get their children to eat vegetables.SubjectsParticipants were 185 children (110 boys, seventy-five girls) aged 4–6 years and their primary caregiver/parent (172 mothers, thirteen fathers).ResultsThe E + R group was able to achieve more days of taste exposure. Both EO and E + R increased liking at post-intervention compared with control and no further change occurred over the follow-up period. All groups increased their intake of the target vegetable at post-intervention. Target vegetable consumption continued to increase significantly over the follow-up period for E + R and control but not for EO.ConclusionsThe findings provide support for the effectiveness of using a sticker reward with a repeated exposure strategy. In particular, such rewards can facilitate the actual tastings necessary to change liking.

scholarly journals Ehretia Microphylla (Tsaang Gubat) versus Loratadine as Treatment for Allergic Rhinitis: A Randomized Controlled Trial

2018 ◽  
Vol 32 (2) ◽  
pp. 6-10 ◽  
Author(s):  
Fatima Angela C. Umali ◽  
Antonio H. Chua
Keyword(s):  
Allergic Rhinitis ◽  
Treatment Group ◽  
Nasal Congestion ◽  
Controlled Trial ◽  
Control Group ◽  
Post Intervention ◽  
Intermittent Allergic Rhinitis ◽  
Vas Scores ◽  
And Control ◽  
Snot 22

  Objective:  To determine if Ehretia microphylla (Tsaang Gubat) decoction tea and placebo can improve the symptoms of mild intermittent allergic rhinitis in comparison to loratadine and control tea.   Methods: Study Design:            Double blind, Randomized Controlled Trial Setting:                       Tertiary Government Training Hospital Subjects:                    Twenty-four patients diagnosed with mild intermittent allergic rhinitis from October 2015 to July 2016 were randomly divided into a treatment group given Ehretia microphylla (Tsaang Gubat) decoction tea and placebo, and a control group given control tea and loratadine, both taken for 7 days. Patients underwent pre–  and post–intervention evaluation by anterior rhinoscopy, Sino-nasal Outcome Test 22 (SNOT 22) Questionnaire and 10-point Visual Analog Scale (VAS). Data were encoded and subjected to statistical analysis using Mann Whitney U test, and Wilcoxon Signed Rank test.   Results: Age and gender of the treatment and control group participants were comparable. Prior to intervention, no differences in symptoms were noted between both groups on SNOT 22 and VAS scores. After intervention, no differences in symptoms were noted between the 2 groups on SNOT 22 and VAS scores either. Comparison of pre- (30.4 ± 17.3) and post- (7.2 ± 6.5) intervention mean SNOT 22 scores of the loratadine control group with pre- (32.5 ± 23.7) and post- (7.8 ± 10.4) intervention mean SNOT 22 scores of the Ehretia Microphylla treatment group showed significant improvement of symptoms in both groups. Likewise, comparison of pre- and post-intervention mean VAS scores of the loratadine control group and pre- and post-intervention mean VAS scores of the Ehretia Microphylla treatment group based on symptoms of sneezing, rhinorrhea, nasal congestion and pruritus showed significant improvement of symptoms in both groups (p-values of < .001).                         Conclusion: Ehretia microphylla (Tsaang Gubat) decoction tea may improve symptoms of allergic rhinitis (sneezing, rhinorrhea, pruritus, and nasal congestion) and be taken as an alternative to loratadine in patients with mild intermittent allergic rhinitis. Further clinical trials with more participants may provide stronger evidence for this conclusion.   Keywords: Allergic rhinitis, tsaang gubat, ehretia microphylla, loratadine    

scholarly journals Consumption of melatonin supplement improves cardiovascular disease risk factors and anthropometric indices in type 2 diabetes mellitus patients: A double-blind, randomized, placebo-controlled trial

2020 ◽  
Author(s):  
Hadi Bazyar ◽  
Ahmad Zare Javid ◽  
Hossein Bavi Behbahani ◽  
Fardin Moradi ◽  
Bahman Moradi Poode ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Disease Risk ◽  
Controlled Trial ◽  
Cardiovascular Disease Risk ◽  
Intervention Group ◽  
Control Group ◽  
Post Intervention ◽  
Anthropometric Indices ◽  
Double Blind ◽  
Conicity Index

Abstract Background: Diabetes mellitus is a common chronic disease. Dyslipidemia and hypertension are two complications that may develop in diabetic patients if hyperglycemia, insulin resistance, and weight gain are not controlled. This study investigated the effects of melatonin supplementation on some cardiovascular disease risk factors and anthropometric indices in patients with type 2 diabetes mellitus (T2DM).Materials and Methods: In this double-blind, randomized, placebo-controlled trial, 50 T2DM patients were randomly allocated to intervention and control groups which received two tablets of either melatonin or placebo (250 mg) once a day for eight weeks. Mean arterial pressure (MAP), pulse pressure (PP), the atherogenic index of plasma (AIP), weight, body mass index (BMI), waist and hip circumference (WC, HC), body shape index (ABSI), abdominal volume index (AVI), body adiposity index (BAI), lipid accumulation product (LAP), conicity index, and waist-to-height ratio (WHR) were evaluated in all the patients pre- and post-intervention.Results: Melatonin supplementation for eight weeks significantly decreased the mean levels of MAP, PP, weight, BMI, WC, HC, BAI, AVI, conicity index, and WHR post-intervention (p<0.05). Also, the median changes of MAP, PP, weight, BMI, WC, HC BAI, AVI, and conicity index were significantly lower in the intervention group compared with the control group (p<0.05). A significant increase (p<0.001) was observed in the mean levels of ABSI in the intervention group. The median changes of ABSI were significantly greater in the intervention group compared with the control group (p<0.001).Conclusions: Consumption of melatonin supplement may be effective in controlling arterial pressure and anthropometric indices (as predictors of obesity) in T2DM patients.Trial registration: This trial was registered in the Iranian Registry of Clinical Trials website at 2019/5/17. (IRCT20190303042905N1).

scholarly journals Breast Microecology Improvement Using Probiotics Following Needle Aspiration in Patients With Lactational Breast Abscess: a Multi-center Randomized Double-blind Controlled Trial

2021 ◽  
Author(s):  
Yi Zhang ◽  
Yajun Gao ◽  
Jing Qin ◽  
Xiaoting Li ◽  
Fei Jiang ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Reaction Rates ◽  
Needle Aspiration ◽  
Healing Time ◽  
Control Group ◽  
Cure Rate ◽  
Control Groups ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
And Control

Abstract Background: Studies show that oral probiotics can improve the breast microecology and thus alleviate the inflammatory response; however, there is a lack of experimental data corresponding to cases with existing abscesses. We aimed to investigate the effect of Lactobacillus fermentum CECT5716 during needle aspiration in patients with lactational breast abscesses.Methods: Patients (aged 20–41 years) with lactational single-cavity breast abscesses (diameter 3–6 cm) from 12 hospitals were randomly assigned to the experimental (n=51) and control groups (n=50). Outcome measures included the abscess cure rate on day-5 of treatment, delactation rate, relieving pain rate, and the number of needle aspirations until day-28.Results: The experimental group’s 5-day cure rate (43.1%, 22/51) was significantly higher (p<0.05). The breastfeeding continuation on day-5 did not differ significantly (experimental group: 88.2%, 45/51; control group: 96.0%, 48/50; p=0.269). In the experimental and control groups, 19.6% and 14.0% of patients experienced moderate to severe pain on day-5, respectively, with no statistically significant differences (p=0.451). The median number of needle aspirations up to day-28 was two in the experimental (1–3 times) and control (1–4 times) groups, with no statistically significant differences (Mann–Whitney U test, p=0.322). Four patients in each group developed diarrhea, with adverse reaction rates of 7.84% (4/51) and 8.0% (4/50), respectively. No adverse reactions were reported in the infants.Conclusion: L. fermentum can shorten the healing time in patients with lactational breast abscesses.Trial registration: This study was registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn), registration number: ChiCTR2000032682, registration date: May 6, 2020.

scholarly journals Does Benzocaine Toothpaste Have More Pain-Relieving Effect Compared To Placebo Toothpaste In Orthodontic Patients? A Double-Blind Randomized Controlled Trial

2021 ◽  
Author(s):  
Ladan Eslamian ◽  
Sepideh Soheilifar ◽  
Sanaz Soheilifar ◽  
Seyed Alireza Mortazavi
Keyword(s):  
Orthodontic Treatment ◽  
Controlled Trial ◽  
Repeated Measure ◽  
Control Group ◽  
P Value ◽  
Eligibility Criteria ◽  
Double Blind ◽  
Important Challenge ◽  
Frequent Consumption ◽  
And Control

Abstract Background: Pain management in fixed orthodontic treatment is an important challenge. None of the present methods has been successful in pain relief. The objective of this double-blind cross-over trial was to compare the effect of benzocaine-contained toothpaste and placebo toothpaste on relieving pain caused by fixed orthodontic treatment.Methods and material:Patients undergoing fixed orthodontic treatment at Shahid Beheshti University of Medical Sciences with experience of pain in previous appointment were randomly assigned into 3 groups of 5% benzocaine-contained toothpaste, placebo toothpaste and control group. Eligibility criteria included being in leveling and alignment stage, 6-8 mm space deficiency, no acute or chronic pain or frequent consumption of analgesic drugs. Patients were instructed to use toothpastes 3 times in a day. Main outcome was pain experienced by patients according to Visual Analogue Scale at 8 different time intervals in 7 days. Randomization was done with random numbers in opaque envelopes for sequence of appointments. Blinding was applicable for patients, operator and outcome assessor. Data analysis was done with repeated measure ANOVA for assessing overall effect and Bonferroni for pairwise analysis. P value was assigned to be 0.05.Results: From 33 patients who participated in the study, 27 patients (23 females and 4 males) completed the study. Each patient was randomly allocated to all 3 groups in cross-over design. Mean pain in benzocaine group was less than the placebo and control group (28.63± 25.43, 31.31± 22.09 and 31.20 ± 24.09, respectively). Benzocaine toothpaste group experienced statistically significantly less pain than the other two groups at 2 hours (P˂ 0.015). No adverse event was observed in patients.Conclusion:Benzocaine contained toothpaste can decrease pain perceived at first hours after orthodontic appointment. Registration and protocol: This trial was registered in Iranian Registry of Clinical Trials (IRCT2015010120523N1) at 16/04/2015.

scholarly journals Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium risk hypertension: study protocol for a randomized double-blind controlled trial

2021 ◽  
Author(s):  
xiaochen Yang ◽  
Xingjiang Xiong ◽  
Yun Zhang ◽  
Yongmei Liu ◽  
Hongzheng Li ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Inflammatory Responses ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Medium Risk ◽  
Tcm Syndrome ◽  
And Control

Abstract IntroductionHypertension is one of the most important risk factors for cardiovascular disease, and its treatment and control rates are still low worldwide. The most effective strategy is that patients with hypertension should be diagnosed and treated early. Preliminary studies showed that the Bushen Jiangya granule (BSJY) may suppress ventricular hypertrophy and inflammatory responses, lower blood pressure and protect the target organs of hypertension. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of BSJY in patients with low-to-medium risk hypertension.Methods and analysisThis trial is a one-center, randomized, double-blind, placebo-controlled study. A total of 260 participants will be randomized in a 1:1 ratio to an experiment group (BSJY plus amlodipine) and a control group (placebo plus amlodipine). The trial cycle will last 8 weeks. The primary outcome is blood pressure, which is reduced to a threshold set out in Guiding Principles for Clinical Research of New Chinese Medicines. The secondary outcomes include the change in 24-h average systolic and diastolic blood pressure, heart rate variability, pharmacogenomic Evaluation, improvement in TCM Syndrome, serum pro-inflammatory/anti-inflammatory cytokines, etc. between the two groups. Safety in medication will also be evaluated. All the data will be recorded in electronic case report forms and analyzed by SPSS V.22.0.Ethics and dissemination This study has been approved by Research Ethics Committee of Guang’anmen Hospital,China Academy of Chinese Medical Sciences in Beijing, China (No. 2019-186-KY-01). The participants are volunteers, understand the process of this trial and sign an informed consent. The results of this study will be disseminated to the public through peer-reviewed journals and academic conferences. DiscussionWe hypothesize that patients with low-to-medium risk hypertension will benefit from BSJY. If successful, this study will provide evidence-based recommendations for clinicians.

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