scholarly journals Effects of a Rice Bran Dietary Intervention on the Composition of the Intestinal Microbiota of Adults with a High Risk of Colorectal Cancer: A Pilot Randomised-Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 526
Author(s):  
Winnie K. W. So ◽  
Judy Y. W. Chan ◽  
Bernard M. H. Law ◽  
Kai Chow Choi ◽  
Jessica Y. L. Ching ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
High Risk ◽  
Intestinal Microbiota ◽  
Rice Bran ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Intestinal Health ◽  
Health Promoting

Rice bran exhibits chemopreventive properties that may help to prevent colorectal cancer (CRC), and a short-term rice bran dietary intervention may promote intestinal health via modification of the intestinal microbiota. We conducted a pilot, double-blind, randomised placebo-controlled trial to assess the feasibility of implementing a long-term (24-week) rice bran dietary intervention in Chinese subjects with a high risk of CRC, and to examine its effects on the composition of their intestinal microbiota. Forty subjects were randomised into the intervention group (n = 19) or the control group (n = 20). The intervention participants consumed 30 g of rice bran over 24-h intervals for 24 weeks, whilst the control participants consumed 30 g of rice powder on the same schedule. High rates of retention (97.5%) and compliance (≥91.3%) were observed. No adverse effects were reported. The intervention significantly enhanced the intestinal abundance of Firmicutes and Lactobacillus, and tended to increase the Firmicutes/Bacteroidetes ratio and the intestinal abundance of Prevotella_9 and the health-promoting Lactobacillales and Bifidobacteria, but had no effect on bacterial diversity. Overall, a 24-week rice bran dietary intervention was feasible, and may increase intestinal health by inducing health-promoting modification of the intestinal microbiota. Further larger-scale studies involving a longer intervention duration and multiple follow-up outcome assessments are recommended.

INOVASIA Study: A Randomized Open Controlled Trial to Evaluate Pravastatin to Prevent Preeclampsia and its Effects on sFlt1/PLGF Levels

2021 ◽  
Author(s):  
Muhammad Ilham Aldika Akbar ◽  
Angelina Yosediputra ◽  
Raditya Eri Pratama ◽  
Nur Lailatul Fadhilah ◽  
Sulistyowati Sulistyowati ◽  
...  
Keyword(s):  
High Risk ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Perinatal Outcomes ◽  
Neonatal Morbidity ◽  
Clinical Risk Factor ◽  
Control Group ◽  
Significant Deterioration ◽  
Plgf Ratio

Objectives To evaluate the effect of pravastatin to prevent preeclampsia (PE) in pregnant women at a high risk of developing preeclampsia and the maternal and perinatal outcomes and the sFlt1/PLGF ratio. Study Design This is an open labelled RCT part of INOVASIA trial. Pregnant women at a high risk of developing PE were recruited and randomized into an intervention group (40) and a control group (40). The inclusion criteria consisted of pregnant women with positive clinical risk factor and abnormal uterine artery doppler examination at 10-20 weeks gestational age. The control group received low dose aspirin (80 mg/day) and calcium (1 g/day), while the intervention group received additional pravastatin (20 mg twice daily) starting from 14-20 weeks gestation until delivery. Research blood samples were collected before the first dose of pravastatin and before delivery. The main outcome was the rate of maternal preeclampsia, maternal-perinatal outcomes, and sFlt-1, PLGF, sFlt-1/PlGF ratio and sEng levels. Results The rate of preeclampsia was (non-significantly) lower in the pravastatin group compared with the control group (17.5% vs 35%). The pravastatin group also had a (non-significant) lower rate of severe preeclampsia, HELLP syndrome, acute kidney injury and severe hypertension. The rate of (iatrogenic) preterm delivery was significantly (p=0.048) lower in the pravastatin group (n=4) compared with the controls (n=12). Neonates in the pravastatin group had significantly higher birthweights (2931 + 537 vs 2625 + 872 g; p=0.006), lower Apgar scores < 7 (2.5 vs 27.5%, p=0.002), composite neonatal morbidity (0 vs 20%, p=0.005) and NICU admission rates (0 vs 15%, p=0.026). All biomarkers show a significant deterioration in the control group compared with non significant changes in the pravastatin group. Conclusions Pravastatin holds promise in the secondary prevention of preeclampsia and placenta-mediated adverse perinatal outcomes by improving the angiogenic imbalance.

Abstract TP168: Efficacy of a Pictogram to Promote Stroke Knowledge Among Illiterate Korean Elderly

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Cha-Nam Shin ◽  
Jeongha Sim ◽  
Dongchoon Ahn
Keyword(s):  
Older Adults ◽  
High Risk ◽  
Longitudinal Research ◽  
Controlled Trial ◽  
Intervention Group ◽  
Warning Signs ◽  
Repeated Measure ◽  
Control Group ◽  
Control Group Design ◽  
Stroke Knowledge

Background and Purpose: Extensive research supports the importance of knowledge in stroke prevention and reducing prehospital delay time. However, the level of stroke knowledge among Korean older adults remains low. In particular, older adults who are illiterate lack of stroke information despite being at high risk. The purpose of this study was to develop and examine the efficacy of a pictogram to enhance stroke knowledge in the high-risk and illiterate older adults. Methods: We conducted a pretest-posttest nonequivalent control group design study and compared differences in stroke knowledge before and after the intervention. A total of 117 older adults (82 in the intervention group and 35 in the control group) who were 60 years and older residing in community participated in the study. Participants in the intervention group received a pictogram-based education, while participants in the control group received a powerpoint-based education. Stroke knowledge was measured by structured survey questionnaires. Descriptive statistics for sample characteristics, repeated measure ANOVA for the efficacy, and independent t-test for satisfaction comparison between groups were used. Results: The intervention group showed a higher increase in stroke knowledge (F=16.45), awareness of risk factors (F=15.71), stroke warning signs and symptoms (F=17.29), and action at stroke (F=19.36) compared to the control group at p <.001. Also, the intervention group reported that they would recommend the education program to others (t=2.64, p<.05) and the program was applicable to real situation (t=4.47, p <.001), which were scored higher than the control group. Conclusions: The data revealed that a pictogram-based education is more effective than a powerpoint-based education among illiterate older adults. Replicated studies with this pictogram in a larger randomized controlled trial is warranted, which may give greater validity to our findings. Future longitudinal research is recommended to examine retention of stroke knowledge over the long term.

scholarly journals A Lifestyle (Dietary) Intervention Reduces Tiredness in Children with Subclinical Hypothyroidism, a Randomized Controlled Trial

2020 ◽  
Vol 17 (10) ◽  
pp. 3689
Author(s):  
Ellen van der Gaag ◽  
Job van der Palen ◽  
Pim Schaap ◽  
Mirthe van Voorthuizen ◽  
Thalia Hummel
Keyword(s):  
Lipid Profile ◽  
Subclinical Hypothyroidism ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Thyroid Stimulating Hormone ◽  
Control Group ◽  
Significant Difference ◽  
Scale Scores

Purpose: Subclinical hypothyroidism (SH) in children and adults is a subject for discussion in terms of whether to treat it or not with respect to the short-term clinical implications and consequences of SH and in the long term. If treatment with thyroxine supplementation is not indicated, no other treatment is available. We investigated whether a lifestyle (dietary) intervention improves or normalizes SH or decreases the presence of Thyroid Stimulating Hormone (TSH) and/or tiredness. Methods: We randomized children aged 1–12 years with SH to the control group (standard care = no treatment) or intervention group (dietary intervention). The dietary intervention consisted of green vegetables, beef, whole milk and butter for 6 months. The rest of the diet remained unchanged. We measured TSH, FreeT4, Lipid profile, Body Mass Index (BMI) and Pediatric Quality of Life (PedQL) multidimensional fatigue scale scores. Results: In total, 62 children were included. After 6 months, TSH decreased in both groups without a significant difference between the groups (p = 0.98). PedQL fatigue scores for sleep (p = 0.032) and total fatigue scores (p = 0.039) improved significantly in the intervention group, compared to the control group. No unfavorable effects occurred in the lipid profile or BMI. Conclusion: The lifestyle (dietary) intervention did not normalize SH and TSH levels, but it significantly reduced tiredness. These results suggest that children’s well-being can be improved without medication.

scholarly journals Malnutrition in an obese world: Can a dietary intervention improve iron status in pre-school children?

2020 ◽  
Vol 79 (OCE2) ◽  
Author(s):  
Ellen van der Gaag ◽  
Kim Grootelaar ◽  
Thalia Hummel
Keyword(s):  
Iron Deficiency ◽  
School Children ◽  
Dietary Intervention ◽  
Growth Parameters ◽  
Iron Status ◽  
Controlled Trial ◽  
Intervention Group ◽  
Dietary Advice ◽  
Control Group ◽  
National Guidelines

AbstractIntroduction:In previous studies iron deficiency was present in preschool children in the developed world1. The objective of this randomized controlled trial was to investigate whether iron deficiency was present in pre-school children and to what extend laboratory values could be improved with a nutrient rich diet.Material and Methods:A diet consisting of green vegetables, beef, full-fat milk and butter was developed. This diet comes close to the traditional Dutch diet from a century ago. All food products were in age appropriate portions, according to the national guidelines. Children aged one to four years, who were referred to the paediatrician due to recurrent URTI (without immunologic disorders) were allocated to the intervention or the control group. Both groups were given standard care. The intervention group was also given the dietary advise. All parents were asked to note of daily food intake.Results:No iron deficiency was present in our group of 1–4 years old. Mean Hb was 7.3 mmol/l in both groups. After following the dietary advice for 6 months,the hemoglobulin (Hb) concentration increased in both groups, but a little more in the intervention group :(0,280 mmol/l; p < 0,001 in the dietary intervention group and 0,214 mmol/l in the control group; p = 0,003). MCV values increased in the interventiongroup from 77.9 to 78.8 fl (p = 0.007) whereas a smaller increase was visible in the control group ;78.5 to 78.9 fl (p = 0.18). Ferritin, a marker for iron status but also a marker for inflammation, decreased non-significantly in both groups. There was a significantly correlation with decreasing CRP levels, therefore indicating a decrease in inflammation and not merely representing iron status. Growth parameters (weight, height or BMI) did not change significantly in both groups.Discussion and Conclusion:NoHb deficiency was present in our research population. However, a diet consisting of green vegetables, beef, full-fat milk and butter did improve the iron status in pre-school children. Hb and MCV values increased, suggesting some evidence of subclinical iron deficiency in this group.

scholarly journals INOVASIA Study: A Randomized Open Controlled Trial to Evaluate Prophylactic Pravastatin in the Prevention of Preeclampsia and its Effects on sFlt1/PLGF Levels in Pregnant Women at High Risk of Developing Preeclampsia

2021 ◽  
Author(s):  
Muhammad Ilham Aldika Akbar ◽  
Angelina Yosediputra ◽  
Raditya Eri Pratama ◽  
Nur Lailatul Fadhilah ◽  
Sulistyowati Sulistyowati ◽  
...  
Keyword(s):  
High Risk ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Perinatal Outcomes ◽  
Clinical Risk Factor ◽  
Control Group ◽  
Significant Deterioration ◽  
Secondary Outcomes ◽  
Plgf Ratio

Objectives The study aim is to evaluate the effect of pravastatin to prevent preeclampsia (PE) in pregnant women at a high risk of developing preeclampsia and the maternal and perinatal outcomes and the sFlt1/PLGF ratio in the Surabaya cohort of the INOVASIA trial. Setting This study involved 2 academic hospital (a tertiary and secondary center) in Surabaya, Indonesia. Participants Pregnant women at a high risk of developing PE were recruited and randomized into an intervention group (40) and a control group (40). The inclusion criteria consisted of pregnant women with positive clinical risk factor and abnormal uterine artery doppler examination at 10-20 weeks gestational age. Inteventions The control group received low dose aspirin (80 mg/day) and calcium (1 g/day), while the intervention group received additional pravastatin (20 mg twice daily) starting from 14-20 weeks gestation until delivery. Research blood samples were collected before the first dose of pravastatin, and just before delivery. Primary and Secondary Outcomes The primary outcome was the rate of maternal preeclampsia, secondary outcomes included maternal-perinatal outcomes and sFlt-1, PLGF, sFlt-1/PlGF ratio and sEng levels. Results The rate of preeclampsia was (non-significantly) lower in the pravastatin group compared with the control group (17.5% vs 35%). The pravastatin group also had a (non-significant) lower rate of severe preeclampsia, HELLP syndrome, acute kidney injury and severe hypertension. The rate of (iatrogenic) preterm delivery was significantly lower (p 0.048) in the pravastatin group (n=4) compared with the controls (n=12). Neonates in the pravastatin group had significantly higher birthweights, higher Apgar scores, and lower composite neonatal morbidity and NICU admission rates. All biomarkers show a significant deterioration in the control group compared with non-significant changes in the pravastatin group. Conclusions Pravastatin holds promise in the secondary prevention of preeclampsia and placenta-mediated adverse perinatal outcomes by improving the anti-angiogenic/pro-angiogenic imbalance. Trial Registration Clinical Trial Gov (ID: NCT03648970)

scholarly journals Effectiveness of a digital dietary intervention program targeting young adults before parenthood: protocol for the PREPARED randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e055116
Author(s):  
Nina Cecilie Øverby ◽  
Anine C Medin ◽  
Erlend Larsen Valen ◽  
Lorentz Salvesen ◽  
Andrew Keith Wills ◽  
...  
Keyword(s):  
Young Adults ◽  
Intervention Program ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Perinatal Outcomes ◽  
Dietary Behaviour ◽  
Control Group ◽  
Next Generation ◽  
Maternal Risk

IntroductionThe importance of preconception health for lifelong physical and mental health in the next generation has gained increasing recognition in recent years. Preconception paternal and maternal risk factors such as obesity and inadequate diet affect the metabolic and cardiovascular health of their offspring later in life. This highlights the importance of diet and dietary behaviour in the years before parenthood. In our project, PREPARED, we will evaluate the effectiveness of a digital intervention targeting young adults. Our primary aim is to improve participants’ preconception diet, and our secondary aim is to improve preconception quality of life and maternal and child perinatal outcomes.Methods and analysisWe plan to recruit 7000 men and women individually, aged 20–35 years without children, to be randomised to an intervention or a control group. The intervention group will receive access to a digital resource for 6 months promoting a healthy diet for their health now, later in life and for the next generation. Follow-up is up to 20 years or until they have their first child. To evaluate intervention effects, we will collect dietary data (2×24-hour dietary recalls and a screener). For those participants for which birth ensues, we will link study data with data from the Medical Birth Registry of Norway on maternal and child perinatal outcomes.Ethics and disseminationThe study is approved by the Regional Ethics Committee, the Norwegian Data Protection Service and our Faculty Ethical Committee (REC: 78104, NSD: 907212, FEC 20/10119). Participation is voluntary and all participants will provide informed consent. Participants can withdraw their consent without giving any reason. Findings will be communicated to the public through a project website and social media, and to professionals through conferences and peer-reviewed papers.Trial registration numberISRCTN44294662.

The effects of an educational program based on the Theory of Reasoned Action on high-risk sexual behaviors among patients with human papillomavirus infection: a randomized controlled trial

2020 ◽  
Author(s):  
Nima Pourgholamamiji ◽  
Hooman Shahsavari ◽  
Arpi Manookian ◽  
Tahereh Soori ◽  
Maryam zandkarimkhani
Keyword(s):  
Human Papillomavirus ◽  
High Risk ◽  
Sexual Behaviors ◽  
Educational Program ◽  
Theory Of Reasoned Action ◽  
Reasoned Action ◽  
Controlled Trial ◽  
Intervention Group ◽  
Hpv Infection ◽  
Control Group

Abstract Background: Sexually transmitted diseases are a major health problem in all countries. Human papillomavirus (HPV) infection is the most common viral sexually transmitted disease in both genders. High-risk sexual behaviors (HRSBs) are among the major risk factors for HPV infection. Lack of knowledge can contribute to HRSBs and hence, education can potentially reduce HRSB risk. This study evaluated the effects of an educational program based on the Theory of Reasoned Action on HRSBs among patients with HPV. Methods: This two-group randomized controlled trial was conducted in 2017-2018. The educational program was developed based on the results of a survey into the most important components of the Theory of Reasoned Action contributing to HRSBs among 100 patients recruited from Razi hospital, Tehran, Iran. Then, 110 patients from the same hospital were consecutively recruited and randomly allocated to a control (n = 55) and an intervention (n = 55) group and all of them completed a demographic questionnaire and the Sexual Risk Scale. Then, each participant in the intervention group was provided with the developed educational program which consisted of two face-to-face educational sessions in the first and the thirtieth days of the intervention, an educational booklet, and biweekly follow-up telephone contacts. Their counterparts in the control group solely received routine care services. Three months after the first educational session, HRSBs were reassessed in both groups. Results: There were no significant between-group differences respecting participants’ baseline characteristics and mean score of HRSBs (P > 0.05). After the intervention, the mean score of HRSBs significantly decreased in the intervention group (P < 0.001) but did not significantly change in the control group (P = 0.70). The posttest mean score of HRSBs in the intervention group was significantly less than the control group (P = 0.015). Conclusion: Education based on the Theory of Reasoned Action is effective in significantly reducing HRSBs among patients with HPV infection. Nurses can develop and use educational interventions based on this theory to reduce HRSBs and HPV infection. Trial registration: IRCT2016121831453N1 (8 Oct 2017) Keywords: Theory of Reasoned Action, High-risk sexual behaviors, Human papillomavirus

Evaluation of an AIDS educational game (AIDS Fighter · Health Defense) for young students to improve AIDS-related knowledge, stigma and attitude of high-risk behaviors in China: A Pilot Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Jian Tang ◽  
Xingli Yu ◽  
Jianlan Ren ◽  
Mei Li ◽  
Yue Luo
Keyword(s):  
High Risk ◽  
Risk Behaviors ◽  
Controlled Trial ◽  
Intervention Group ◽  
Educational Game ◽  
Control Group ◽  
High Risk Behaviors ◽  
Randomized Controlled ◽  
Young Students ◽  
Pilot Randomized Controlled Trial

BACKGROUND The AIDS epidemic among young students is serious, and effective preventive interventions are urgently needed. Game-based intervention has become an innovative way to change healthy behaviors, and we have developed an AIDS educational game called AIDS Fighter · Health Defense. In this study we pilot-tested the effect of an AIDS Fighter · Health Defense for young students to improve AIDS-related knowledge, stigma and attitude of high-risk behaviors in Southwest China. OBJECTIVE To pilot-test the effect of an AIDS educational game (AIDS Fighter · Health Defense) for young students to improve AIDS-related knowledge, stigma and attitude of high-risk behaviors in Southwest China. METHODS A pilot randomized controlled trial was conducted from September 14 to September 27, 2020. Ninety-six students from two classes in a middle school were selected by stratified cluster sampling in Luzhou City, China. The two classes were randomly divided into the intervention group (n=50) and the control group (n=46) . The intervention group received AIDS educational game (AIDS Fighter · Health Defense); the control group learned AIDS-related knowledge through independent learning on the QQ chat group. The AIDS-related knowledge questionnaire, the stigma scale, the attitude questionnaire on AIDS-related high-risk behaviors were used to measure the effect of an AIDS educational game. The user's experience of the game was assessed by the Educational Game User Experience Evaluation Scale. SPSS 21.0 was used to analyze the data, and the difference was statistically significant with P≤0.05. RESULTS After the intervention, the AIDS knowledge awareness rate (X ̅±S, ％) of the intervention group and the control group were 70.09±11.58 and 57.49±16.58（t=4.282, P<0.001）. The stigma scores of the two groups were 2.44±0.57 and 2.48±0.47（t=0.354, P =0.724）, The positive rate (X ̅±S, ％) of attitudes of high-risk AIDS behaviors of the two groups were 82.00±23.44 and 79.62±17.94（t=0.555, P =0.580. A total of 54.73% of users rated the game as excellent, 31.45% of good, 13.09% of medium, and 0.73% of poor. CONCLUSIONS AIDS Fighter · Health Defense could increase the AIDS-related knowledge among young students, but the effect in reducing AIDS-related stigma and improving the attitudes of high-risk AIDS behaviors has not appeared. Long-term effects and large-scale studies are needed to assess the efficacy of game-based intervention. CLINICALTRIAL Chinese Clinical Trial Registry (ChiCTR2000038230)

scholarly journals A web-based dietary intervention in early pregnancy and neonatal outcomes: a randomized controlled trial

2018 ◽  
Vol 41 (2) ◽  
pp. 371-378 ◽  
Author(s):  
R A K Kennedy ◽  
C M E Reynolds ◽  
S Cawley ◽  
E O’Malley ◽  
D M McCartney ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Neonatal Outcomes ◽  
Dietary Behaviour ◽  
Control Group ◽  
Evidence Based ◽  
Randomized Controlled

Abstract Background Maternal nutrition is a determinant of pregnancy outcomes. Few studies have evaluated the potential of online nutrition resources to modify behaviour. This randomized controlled trial aimed to determine whether access to a customized evidence-based nutrition website in pregnancy improved neonatal outcomes. Methods Women <18 weeks gestation were recruited at their convenience. The control group received standard care. In addition to standard care, the intervention group received access to an evidence-based nutrition website, customized to the preferences of pregnant women. Results Of the 250 women, there were no differences in characteristics between the two groups. Of the women, 91.0% reported they make a conscious effort currently to eat a healthy diet. However, only 19.6% met dietary requirements for calcium, 13.2% for iron, 2.7% for folate and 2.3% for iodine. The most popular website section was pregnancy nutrition advice but engagement was not sustained. Access to the website was not associated with any improvement in clinical outcomes (P > 0.05). Conclusions We found that provision of a customized website providing nutrition information, did not improve neonatal outcomes. Future studies should explore whether redesign with website interactivity or embedding information on popular digital platforms sustains women’s engagement and modifies dietary behaviour.

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