scholarly journals A Dietary Intervention High in Green Leafy Vegetables Reduces Oxidative DNA Damage in Adults at Increased Risk of Colorectal Cancer: Biological Outcomes of the Randomized Controlled Meat and Three Greens (M3G) Feasibility Trial

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1220
Author(s):  
Andrew D. Frugé ◽  
Kristen S. Smith ◽  
Aaron J. Riviere ◽  
Rachel Tenpenny-Chigas ◽  
Wendy Demark-Wahnefried ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Dna Damage ◽  
Dietary Intervention ◽  
Intervention Group ◽  
Leafy Vegetables ◽  
Feasibility Trial ◽  
Plasma Vitamin ◽  
Green Leafy Vegetables ◽  
Randomized Controlled ◽  
Increased Risk

Green leafy vegetables (GLV) may reduce the risk of red meat (RM)-induced colonic DNA damage and colorectal cancer (CRC). We previously reported the primary outcomes (feasibility) of a 12-week randomized controlled crossover trial in adults with habitual high RM and low GLV intake with body mass index (BMI) > 30 kg/m2 (NCT03582306). Herein, our objective was to report a priori secondary outcomes. Participants were recruited and enrolled in 2018, stratified by gender, and randomized to two arms: immediate intervention group (IG, n = 26) or delayed intervention group (DG, n = 24). During the 4 week intervention period, participants were provided with frozen GLV and counseled to consume 1 cooked cup equivalent daily. Participants consumed their normal diet for the remaining 8 weeks. At each of four study visits, anthropometrics, stool, and blood were taken. Overall, plasma Vitamin K1 (0.50 ± 1.18 ng/mL, p < 0.001) increased, while circulating 8OHdG (−8.52 ± 19.05 ng/mL, p < 0.001), fecal 8OHdG (−6.78 ± 34.86 ng/mL, p < 0.001), and TNFα (−16.95 ± 60.82 pg/mL, p < 0.001) decreased during the GLV intervention compared to control periods. Alpha diversity of fecal microbiota and relative abundance of major taxa did not differ systematically across study periods. Further investigation of the effects of increased GLV intake on CRC risk is warranted.

scholarly journals Primary Outcomes of a Randomized Controlled Crossover Trial to Explore the Effects of a High Chlorophyll Dietary Intervention to Reduce Colon Cancer Risk in Adults: The Meat and Three Greens (M3G) Feasibility Trial

Nutrients ◽  
2019 ◽  
Vol 11 (10) ◽  
pp. 2349
Author(s):  
Frugé ◽  
Smith ◽  
Riviere ◽  
Demark-Wahnefried ◽  
Arthur ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Dna Damage ◽  
Oxidative Dna Damage ◽  
Crossover Trial ◽  
Dietary Intervention ◽  
Leafy Vegetables ◽  
Feasibility Trial ◽  
Observational Research ◽  
Randomized Controlled ◽  
Increased Risk

Preclinical and observational research suggests green leafy vegetables (GLVs) may reduce the risk of red meat (RM)-induced colonic DNA damage and colon cancer (CC). We sought to determine the feasibility of a high GLV dietary intervention in adults with an increased risk of CC (NCT03582306) via a 12-week randomized controlled crossover trial. Participants were randomized to immediate or delayed (post-4-week washout) intervention groups. During the 4-week intervention period, participants were given frozen GLVs and counseled to consume one cooked cup equivalent daily. The primary outcomes were: accrual—recruiting 50 adults in 9 months; retention—retaining 80% of participants at completion; and adherence—meeting GLV intake goals on 90% of days. Adherence data were collected twice weekly and 24-h dietary recalls at each time point provided nutrient and food group measures. The Food Acceptability Questionnaire (FAQ) was completed to determine acceptability. On each of the four study visits, anthropometrics, stool, saliva, and blood were obtained. Fifty adults were recruited in 44 days. Participants were 48 ± 13 years of age, 62% female, and 80% Caucasian, with an average BMI at screening of 35.9 ± 5.1. Forty-eight (96%) participants were retained and completed the study. During the intervention phase, participants consumed GLVs on 88.8% of days; the adherence goal of one cup was met on 73.2% of days. Dietary recall-derived Vitamin K and GLVs significantly increased for all participants during the intervention periods. Overall satisfaction did not differ between intervention and control periods (p = 0.214). This feasibility trial achieved accrual, retention and acceptability goals, but fell slightly short of the benchmark for adherence. The analysis of biological specimens will determine the effects of GLVs on gut microbiota, oxidative DNA damage, and inflammatory cytokines.

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Nutritional support for lactating women with or without Azithromycin for infants compared to breast-feeding counselling alone, to improve six-month growth outcomes among infants of peri-urban slums of Karachi, Pakistan – a protocol of multi-arm assessor blinded randomized controlled trial (Mumta LW trial)

2020 ◽  
Author(s):  
Ameer Muhammad ◽  
Yasir Shafiq ◽  
M Imran Nisar ◽  
Benazir Baloch ◽  
Amna Tanweer Yazdani ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Income ◽  
Controlled Trial ◽  
Intervention Group ◽  
Relative Length ◽  
Trial Registration ◽  
Control Group ◽  
Lactating Women ◽  
Randomized Controlled ◽  
Increased Risk

Abstract BackgroundGlobally, 45% of under-five deaths are, directly or indirectly, attributable to malnutrition, most of these deaths are in low- and middle-income countries (LMICs). Children in the first 6 months of life are particularly vulnerable. An estimated 4.7 million infants under the age of 6 months are moderately wasted whereas 3.8 million are severely wasted. Despite the increased risk to a child of a mother with nutritional decompensation, there are discrepancies in guidance in this area. MethodsThis is a community-based, open-label factorial randomized controlled trial, using parallel assignment with 1:1:1 allocation ratio, in low-income squatter settlements of urban Karachi, Pakistan. In the control group (Arm A), women are randomized to standard counseling only; whereas in the first intervention group (Arm B), lactating women receive two sachets of balanced energy-protein (BEP) supplementation per day from enrollment till the infant reaches six months of age, in the second intervention group (Arm C), lactating women receive same BEP as in intervention Arm B while their babies also receive a single stat dose (20mg/kg orally) of azithromycin at 42 days. The primary outcome is relative length velocity from 0 to 6 months by the limb of allocation. The primary analysis will be Intention-to-treat analysisTrial registrationRegistration of the trial is done at ClinicalTrials.gov. NCT03564652, registered on June 21, 2018. Trial registration data is available through https://clinicaltrials.gov/ct2/show/NCT03564652

Impact of the Ser326Cys polymorphism of the OGG1 gene on the level of oxidative DNA damage in patients with colorectal cancer

2018 ◽  
Vol 90 (2) ◽  
pp. 13-15 ◽  
Author(s):  
Jacek Kabzinski ◽  
Anna Walczak ◽  
Adam Dziki ◽  
Michał Mik ◽  
Ireneusz Majsterek
Keyword(s):  
Colorectal Cancer ◽  
Dna Damage ◽  
Oxidative Damage ◽  
Oxidative Dna Damage ◽  
Excision Repair ◽  
Genetic Material ◽  
Control Group ◽  
Ogg1 Gene ◽  
Increased Risk ◽  
Ser326cys Polymorphism

As a result of reactive oxygen species operation, cell damage occurs in both cellular organelles and molecules, including DNA. Oxidative damage within the genetic material can lead to accumulation of mutations and consequently to cancer transformation. OGG1 glycosylase, a component of the Base Excision Repair (BER) system, is one of the enzymes that prevents excessive accumulation of 8-oxoguanine (8-oxG), the most common compound formed by oxidative DNA damage. In case of structural changes of OGG1 resulting from polymorphic variants, we can observe a significant increase in the concentration of 8-oxG. Linking individual polymorphisms to DNA repair systems with increased risk of colorectal cancer will allow patients to be classified as high risk and included in a prophylactic program. The aim of the study was to determine the level of oxidative DNA damage and to analyze the distribution of Ser326Cys polymorphism of the OGG1 gene in a group of patients with colorectal cancer and in a control group in the Polish population. Material and methodology. DNA was isolated from the blood of 174 patients with colorectal cancer. The control group consisted of 176 healthy individuals. The level of oxidative damage was determined by analyzing the amount of 8-oxguanine using the HT 8-oxo-dG ELISA II Kit. Genotyping was performed via the TaqMan method. Results. The obtained results indicate that Ser326Cys polymorphism of the OGG1 gene increases the risk of RJG and is associated with significantly increased levels of 8-oxoguanine. Conclusions. Based on the results obtained, we conclude that Ser326Cys polymorphism of the OGG1 gene may modulate the risk of colorectal cancer by increasing the level of oxidative DNA damage.

scholarly journals Community Assessment of Availability, Consumption, and Cultural Acceptability of Food Sources of (PRO)Vitamin A: Toward the Development of a Dietary Intervention among Preschool Children in Rural Burkina Faso

2005 ◽  
Vol 26 (4) ◽  
pp. 356-365 ◽  
Author(s):  
Constance P. Nana ◽  
Inge D. Brouwer ◽  
Noel-Marie Zagré ◽  
Frans J. Kok ◽  
Alfred S. Traoré
Keyword(s):  
Vitamin A ◽  
Burkina Faso ◽  
Rural Areas ◽  
Dietary Intervention ◽  
Vitamin A Deficiency ◽  
Public Health Problem ◽  
Ethnographic Study ◽  
Leafy Vegetables ◽  
Food Sources ◽  
Green Leafy Vegetables

Background Vitamin A deficiency remains a public health problem in Burkina Faso and elsewhere in the developing world. Dietary diversification is a promising strategy that needs to be explored to strengthen the country's ongoing supplementation program. Objective The purpose of this study was to identify locally available and acceptable (pro)vitamin A–rich foods to be included in a dietary intervention addressing vitamin A deficiency in children aged six months to three years. Methods A food ethnographic study combining recall methods, observation, and focused group discussion was conducted in the dry and rainy seasons. Thirty-five mother–child pairs were randomly selected and included in the study. Results The dietary pattern of children was characterized by low diversity with extremely low energy and vitamin A intake in both seasons. The study identified the availability of numerous (pro)vitamin A–rich foods, but these foods are either not consumed or consumed by few in low amounts and/or in low frequencies. The main constraining factors identified are related to financial accessibility (for liver), seasonal availability (for egg, milk, mango, papaya, and green leafy vegetables), and beliefs related to consumption and preparation (for green leafy vegetables). However, the study also revealed that the study population associated all identified (pro)vitamin A–rich foods with positive attributes such as health, strength, and vitamin richness, which might offer an entry point for designing and implementing dietary interventions. Conclusions Based on the findings of this formative research, intervention strategies with mango and liver are proposed to improve the vitamin A intake and status of children in the rural areas of Burkina Faso.

Health Care Provider-Directed Intervention to Increase Colorectal Cancer Screening Among Veterans: Results of a Randomized Controlled Trial

2005 ◽  
Vol 23 (7) ◽  
pp. 1548-1554 ◽  
Author(s):  
M. Rosario Ferreira ◽  
Nancy C. Dolan ◽  
Marian L. Fitzgibbon ◽  
Terry C. Davis ◽  
Nicolle Gorby ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Cancer Screening ◽  
Colorectal Cancer Screening ◽  
Controlled Trial ◽  
Intervention Group ◽  
Group Versus ◽  
Literacy Skills ◽  
Randomized Controlled

Purpose Colorectal cancer screening is the most underused cancer screening tool in the United States. The purpose of this study was to test whether a health care provider–directed intervention increased colorectal cancer screening rates. Patients and Methods The study was a randomized controlled trial conducted at two clinic firms at a Veterans Affairs Medical Center. The records of 5,711 patients were reviewed; 1,978 patients were eligible. Eligible patients were men aged 50 years and older who had no personal or family history of colorectal cancer or polyps, had not received colorectal cancer screening, and had at least one visit to the clinic during the study period. Health care providers in the intervention firm attended a workshop on colorectal cancer screening. Every 4 to 6 months, they attended quality improvement workshops where they received group screening rates, individualized confidential feedback, and training on improving communication with patients with limited literacy skills. Medical records were reviewed for colorectal cancer screening recommendations and completion. Literacy level was assessed in a subset of patients. Results Colorectal cancer screening was recommended for 76.0% of patients in the intervention firm and for 69.4% of controls (P = .02). Screening tests were completed by 41.3% of patients in the intervention group versus 32.4% of controls (P = .003). Among patients with health literacy skills less than ninth grade, screening was completed by 55.7% of patients in the intervention group versus 30% of controls (P < .01). Conclusion A provider-directed intervention with feedback on individual and firm-specific screening rates significantly increased both recommendations and colorectal cancer screening completion rates among veterans.

36 Nutrigenetic-Guided Dietary Intervention and Weight Loss: A Randomized Controlled Feasibility Trial

2015 ◽  
Vol 148 (4) ◽  
pp. S-11
Author(s):  
Jeremy Egnatios ◽  
Karen A. Frankwich ◽  
Mandy L. Kenyon ◽  
Thomas Rutledge ◽  
Patricia S. Liao ◽  
...  
Keyword(s):  
Weight Loss ◽  
Dietary Intervention ◽  
Feasibility Trial ◽  
Randomized Controlled

scholarly journals First Trimester Metabolites Predict Gestational Diabetes Mellitus Diagnosis: A Case: Control Study (FS03-04-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Manuel Ramos ◽  
Anna Lamb ◽  
Noemi Alarcon ◽  
Adilene Quintana-Diaz ◽  
Rob Fanter ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Dietary Intervention ◽  
Intervention Group ◽  
First Trimester ◽  
Case Control ◽  
Plasma Metabolites ◽  
Blood Draw ◽  
Increased Risk

Abstract Objectives Gestational Diabetes Mellitus (GDM) has an overall prevalence estimated as high as 13% of overweight/obese (OW/OB) pregnant women. Since the occurrence of GDM can have a combination of adverse perinatal outcomes and long-term increased risk of health issues in the future for both the mother and child, it is important that the mechanisms involved in this disease are better understood so that better prevention strategies can be devised. We sought to identify early and late pregnancy metabolites that discriminated women who developed vs. did not develop GDM to provide insight into its etiology and help improve treatments. Methods Participants were 26 OW/OB women enrolled in the Healthy Beginnings Trial and completed blood draws at 13 weeks, 26 weeks, and 35 weeks gestation. Participants from the control and dietary intervention group who developed GDM (N = 12) were matched on age and study entry BMI with those who did not develop GDM (N = 14). Plasma samples were analyzed by ultra-high-performance liquid chromatography-hybrid triple‐quadrupole linear ion trap mass spectrometry (UPLC-QTRAP) using two targeted metabolomics assays for primary metabolomics and aminomics. Results A total of 142 metabolites were identified. Most metabolite differences were observed during the first trimester blood draw, prior to GDM diagnosis. At first trimester, metabolites related to energy metabolism that were altered included lower levels of alpha-ketoglutarate and glycerol-3-phosphate, as well as the medium-chain acylcarnitines’ lauroyl-carnitine, dodecenoyl-carnitine, and octanoyl-carnitine (P < 0.05). Interestingly, the neurotransmitters serotonin and glutamate were elevated in subjects who later developed GDM (P < 0.01). In regards to the observed elevated creatine, the lower concentrations of methionine and glycine may suggest utilization of these amino acids for its production (P < 0.03). Lastly, the gut microbiota-derived indole-3-propionate was higher in GDM cases (P < 0.05). In the third trimester of the GDM group, only levels of 4-pyridoxate (vitamin B-6) were lowered (P < 0.05). Conclusions Metabolic changes associated with the numerous plasma metabolites that were different between GDM case-control subjects during first trimester may predict the development of this condition. Funding Sources NIH, ARI.

Effectiveness of chlorhexidine dressings to prevent catheter-related bloodstream infections. Does one size fit all? A systematic literature review and meta-analysis

2020 ◽  
Vol 41 (12) ◽  
pp. 1388-1395
Author(s):  
Mireia Puig-Asensio ◽  
Alexandre R. Marra ◽  
Christopher A. Childs ◽  
Mary E. Kukla ◽  
Eli N. Perencevich ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Intervention Group ◽  
Bloodstream Infections ◽  
Control Group ◽  
Exit Site ◽  
Short Term ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Pediatric Populations

AbstractObjective:To evaluate the effectiveness of chlorhexidine (CHG) dressings to prevent catheter-related bloodstream infections (CRBSIs).Design:Systematic review and meta-analysis.Methods:We searched PubMed, CINAHL, EMBASE, and ClinicalTrials.gov for studies (randomized controlled and quasi-experimental trials) with the following criteria: patients with short- or long-term catheters; CHG dressings were used in the intervention group and nonantimicrobial dressings in the control group; CRBSI was an outcome. Random-effects models were used to obtain pooled risk ratios (pRRs). Heterogeneity was evaluated using the I2 test and the Cochran Q statistic.Results:In total, 20 studies (18 randomized controlled trials; 15,590 catheters) without evidence of publication bias and mainly performed in intensive care units (ICUs) were included. CHG dressings significantly reduced CRBSIs (pRR, 0.71; 95% CI, 0.58–0.87), independent of the CHG dressing type used. Benefits were limited to adults with short-term central venous catheters (CVCs), including onco-hematological patients. For long-term CVCs, CHG dressings decreased exit-site/tunnel infections (pRR, 0.37; 95% CI, 0.22–0.64). Contact dermatitis was associated with CHG dressing use (pRR, 5.16; 95% CI, 2.09–12.70); especially in neonates and pediatric populations in whom severe reactions occurred. Also, 2 studies evaluated and did not find CHG-acquired resistance.Conclusions:CHG dressings prevent CRBSIs in adults with short-term CVCs, including patients with an onco-hematological disease. CHG dressings might reduce exit-site and tunnel infections in long-term CVCs. In neonates and pediatric populations, proof of CHG dressing effectiveness is lacking and there is an increased risk of serious adverse events. Future studies should investigate CHG effectiveness in non-ICU settings and monitor for CHG resistance.

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