Feasibility of Low-Sodium, High-Potassium Processed Foods and Their Effect on Blood Pressure in Free-Living Japanese Men: A Randomized, Double-Blind Controlled Trial

We aimed to verify the effect of new low-sodium high-potassium seasonings and processed foods containing poly-γ-glutamic acid on blood pressure in free-living settings. To this end, we conducted a randomized, double-blind controlled trial on 187 Japanese men, aged 35–67 years, who did not use antihypertensives. Participants were randomly allocated to an intervention (n = 93) or a control group (n = 94). They were given a boxed lunch and miso soup (average Na and K content for the intervention group: 1175 and 1476 mg; for the control group: 2243 and 703 mg, respectively). Blood pressure was measured three times every morning for 1 week immediately before and during the final week of the trial. On the day before and the final day of the intervention period, 24 h urine samples were collected. After intervention, the intervention group showed a significantly stronger decrease in the urinary sodium-to-potassium ratio than the control group (p < 0.001). The mean difference in systolic blood pressure change after adjustment for baseline values between the two groups was −2.1 (95% CI: −3.6, −0.6) mmHg. Compliance between the groups was similar, suggesting successful blinding. In conclusion, the use of new seasonings and processed foods aimed at lowering blood pressure in free-living settings may be feasible and effective.

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Effects of prayer on the vital signs of patients with chronic kidney disease: randomized controlled trial

Revista da Escola de Enfermagem da USP ◽

10.1590/s1980-220x2016024603236 ◽

2017 ◽

Vol 51 (0) ◽

Cited By ~ 1

Author(s):

Thaila Oliveira Zatiti Brasileiro ◽

Andressa Anunciação de Oliveira Prado ◽

Bianca Bacelar de Assis ◽

Denismar Alves Nogueira ◽

Rogério Silva Lima ◽

...

Keyword(s):

Blood Pressure ◽

Chronic Kidney Disease ◽

Heart Rate ◽

Kidney Disease ◽

Respiratory Rate ◽

Controlled Trial ◽

Group Analysis ◽

Intervention Group ◽

Control Group ◽

Double Blind

Abstract OBJECTIVE To assess the effect of prayer on blood pressure, heart rate and respiratory rate in patients with chronic kidney disease and learn their perception of the intervention. METHOD A randomized controlledtrial, double blind with a sample of volunteers, randomized into an intervention group (n=42) and a control group (n=37). Questionnaires addressing socio-demographic, clinical and spiritual characteristics and the Duke University Religious Index were applied. Blood pressure, heart rate and respiratory rate were measured. The prayer was conducted at three different moments on alternating weeks. The qualitative data were organized and analyzed through Thematic Analysis. RESULTS The sample consisted of 95 randomized volunteers. In the intra-group analysis, a statistically significant reduction (P<0001) of blood pressure, heart rate and respiratory rate was observed in all evaluations of the people who were prayed for. The qualitative analysis resulted in the themes Prayer in a "Place of Suffering" and Positive Evaluation and in the sub-themes Relief from Suffering, Hope for Improvement, and Coping with Hemodialysis. CONCLUSIONPrayer reduced blood pressure, heart rate and respiratory rate in patients who suffer from chronic kidney disease, and the volunteers’ evaluation of the intervention was positive.BrazilianClinicalTrials Registry: RBR-2zv39y.

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Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19–a randomised double-blinded placebo-controlled trial

European Respiratory Journal ◽

10.1183/13993003.00752-2021 ◽

2021 ◽

pp. 2100752

Author(s):

Pradeesh Sivapalan ◽

Charlotte Suppli Ulrik ◽

Therese Sophie Lapperre ◽

Rasmus Dahlin Bojesen ◽

Josefin Eklöf ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Double Blind ◽

Safety Outcome ◽

Hospitalised Patients ◽

Double Blinded ◽

Combined Intervention

BackgroundCombining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for COVID-19.MethodsPlacebo-controlled double-blind randomised multicentre trial. Patients ≥18 years, admitted to hospital for≤48 h (not intensive care) with a positive SARS-CoV-2 RT-PCR test, were recruited. The intervention was 500 mg daily azithromycin for 3 days followed by 250 mg daily azithromycin for 12 days combined with 200 mg twice daily hydroxychloroquine for all 15 days. The control group received placebo/placebo. The primary outcome was days alive and discharged from hospital within 14 days (DAOH14).ResultsAfter randomisation of 117 patients, at the first planned interim analysis, the data and safety monitoring board recommended stopping enrolment due to futility, based on pre-specified criteria. Consequently, the trial was terminated on February 1, 2021. A total of 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median of 9.0 DAOH14 (IQR, 3–11) versus. 9.0 DAOH14 (IQR, 7–10) in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for 1 patient in the intervention group versus. 2 patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for 9 patients in the intervention group versus. 6 patients receiving placebo (p=0.57).ConclusionsThe combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.

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PEMBERIAN PUDING TOMAT PISANG AMBON TERHADAP PENURUNAN TEKANAN DARAH LANSIA HIPERTENSI DI POSBINDU WILAYAH KERJA PUSKESMAS BABAKAN, KOTA MATARAM

Jurnal Gizi Prima ◽

10.32807/jgp.v4i1.126 ◽

2019 ◽

Vol 4 (1) ◽

pp. 31

Author(s):

Mutammi Desira ◽

Niketut Sulendri ◽

Fifi Luthfiyah ◽

Suhaema Suhaema

Keyword(s):

Blood Pressure ◽

Systolic Blood Pressure ◽

Diastolic Blood Pressure ◽

Blood Vessels ◽

Fruits And Vegetables ◽

Research Result ◽

Intervention Group ◽

Control Group ◽

High Potassium ◽

Treatment Research

Background: hypertension or high blood pressure is an increase in one's blood pressure, wherein systolic blood pressure ≥ 140 mmHg and or diastolic blood pressure ≥ 90 mmHg on repeated examinations. Hypertension often occurs in the elderly caused by changes occurring during the aging process that cause the walls of blood vessels to undergo thickening and hardening so that it becomes stiff, the diameter of the cavity of the blood vessels shrink or Narrows. One form of non-pharmacological treatment in overcoming hypertension is by herbal medicine, namely by utilizing the content of potassium in fruits and vegetables, such as bananas and tomatoes containing high potassium that can decrease blood pressure, especially in elderly groups. Research Methods: Type of Quasy-experimental research with Pretest- Posttest with Control Group Draft. The samples in this study were elderly hypertension as many as 18 people with random techniques divided into 2 groups. Group intervention with the giving of tomato banana pudding ambon as much as 175 gram/day for 6 days, while the control group is not given treatment. Research Result: There is a decrease in systolic blood pressure as much as17.8 mmHg (P = 0,002) and diastolic blood pressure as much as 8.9 mmHg(P = 0,347) in the intervention group. Conclusio: There is an influence on the systolic blood pressure but there is no influence on diastolic blood pressure before and after given banana tomato pudding Ambon.

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Effect of Steamed Potato Bread Intake on Glucose, Lipids, and Urinary Na+ and K+: A Randomized Controlled Trial with Adolescents

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17062096 ◽

2020 ◽

Vol 17 (6) ◽

pp. 2096

Author(s):

Haiquan Xu ◽

Yanzhi Guo ◽

Shijun Lu ◽

Yunqian Ma ◽

Xiuli Wang ◽

...

Keyword(s):

Blood Pressure ◽

Randomized Controlled Trial ◽

Systolic Blood Pressure ◽

Total Cholesterol ◽

Controlled Trial ◽

Intervention Group ◽

High Density Lipoproteins ◽

Control Group ◽

Randomized Controlled ◽

Potato Bread

Although potatoes are highly nutritious, many epidemiological studies have connected their consumption with abnormal lipids, diabetes, and hypertension. Steamed potato bread has recently become one of China’s staple foods. A randomized controlled trial was designed to evaluate the effect of steamed potato bread consumption on Chinese adolescents. Four classes from a high school were randomly selected and assigned to the intervention group (two classes) or control group (two classes). The steamed wheat bread (100% raw wheat flour) and potato bread (raw wheat flour to cooked potato flour ratio of 3:7) were provided to the control group and intervention group as staple food once a school day for 8 weeks, respectively. Compared with the control group, the intervention group had significant net changes in systolic blood pressure (4.6 mmHg, p = 0.010), insulin (−4.35 mIU/L, p < 0.001), total cholesterol (−0.13 mmol/L, p = 0.032), and high-density lipoproteins cholesterol (−0.07 mmol/L, p = 0.010). The urinary level of Na+/K+ did not differ between the groups. In conclusion, the intake of steamed potato bread for 8 weeks resulted in positive effects on the total cholesterol and insulin profiles but a negative effect on the systolic blood pressure and high-density lipoproteins cholesterol of adolescents.

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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 ◽

10.3390/md17030157 ◽

2019 ◽

Vol 17 (3) ◽

pp. 157 ◽

Cited By ~ 6

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.

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Low-sodium diet in pregnancy: effects on blood pressure and maternal nutritional status

British Journal Of Nutrition ◽

10.1079/bjn19970069 ◽

1997 ◽

Vol 77 (5) ◽

pp. 703-720 ◽

Cited By ~ 10

Author(s):

Gerrieke D Van Der Maten ◽

Joop M. A Van Raaij ◽

Leontien Visman ◽

Lidwien J. M Van Der Heijden ◽

Herman P Oosterbaan ◽

...

Keyword(s):

Blood Pressure ◽

Intervention Group ◽

Mass Gain ◽

Control Group ◽

Maternal Nutritional Status ◽

Low Sodium Diet ◽

Low Sodium ◽

Nulliparous Women ◽

Energy And Nutrient Intake ◽

In Pregnancy

In ninety-four Dutch nulliparous women the effects of a low-Na diet in pregnancy on blood pressure, energy and nutrient intake, Ca metabolism, Zn and Mg status and body composition were studied longitudinally. The women were randomly divided into an intervention group (n41), which used a low-Na diet (mean urinary Na excretion 61 mmol/24 h) from week 14 of pregnancy until delivery and a control group (n53; mean urinary Na excretion 142 mmol/24 h). No effect of the diet on blood pressure was observed. The use of a low-Na diet resulted in significantly reduced intakes of energy, protein, carbohydrates, fat, Ca, Zn, Mg, Fe and cholesterol. However, the women on the low-Na diet appeared to be able to adapt quite well to the reduced intake since Ca, Zn and Mg homeostasis was maintained. In the case of Ca and Mg this was probably due to the observed reduced urinary excretions of these nutrients. Non-significant reductions in weight gain (1·5 kg) and fat-mass gain (0·9 kg) over pregnancy were found in the women on the low-Na diet. No significant effects of the diet on birth weight or placental weight were observed.

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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

10.21203/rs.3.rs-18733/v2 ◽

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).

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Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

10.21203/rs.3.rs-36678/v1 ◽

2020 ◽

Author(s):

Ricard Carrillo Muñoz ◽

Jose Luis Ballve Moreno ◽

Ivan Villar Balboa ◽

Yolanda Rando Matos ◽

Oriol Cunillera Puertolas ◽

...

Keyword(s):

Primary Care ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Double Blind ◽

Perceived Disability ◽

Randomised Controlled ◽

The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

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Positive Effect of Vitamin D and Magnesium Supplementation on Mental health Status of Attention-Deficit Hyperactive Children; A Randomized Double blind Controlled Clinical Trial

10.21203/rs.3.rs-52324/v1 ◽

2020 ◽

Author(s):

Mostafa Hemamy ◽

Naseh Pahlavani ◽

Gholamreza Askari ◽

Mahsa Malekahmadi

Keyword(s):

Mental Health ◽

Vitamin D ◽

Attention Deficit ◽

Controlled Trial ◽

Neurodevelopmental Disorder ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Magnesium Supplementation ◽

Double Blind

Abstract Background: Attention-Deficit / Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder, characterized by varying severity in attention deficit and hyperactivity. Studies have shown deficiencies in the serum level of magnesium and vitamin D in ADHD. The aim of this study is to determine the effect of Vitamin D and magnesium supplementation on mental health in children with ADHD.Method: This double‑blind, randomized controlled trial was performed on 66 ADHD children. participants were randomly allocated to receive both Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) supplements (n = 33) or placebos (n = 33) for 8 weeks. Strengths and difficulties questionnaire were used to evaluate children’s mental health at baseline and at the end of the study.Results: After 8 weeks of intervention, the serum levels of 25‑hydroxy‑Vitamin D3 and magnesium increased significantly in the intervention group compared with the control group. Also a significant decrease in changes of emotional problems (p=0.001), conduct problems (p=0.002), peer problems (p=0.001), prosocial score (p=0.007), total difficulties (p=0.001), externalizing score (p=0.001), and internalizing score (p=0.001) was seen in intervention group at the end of study.Conclusion: Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) co-supplementation during 8-week could improve the behavioral function and mental health in ADHD. Although further well-designed studies with a larger sample size are needed.the IRCT registration: IRCT2016030326886N1.

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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

10.21203/rs.3.rs-361628/v1 ◽

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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