A randomized controlled cross-over trial investigating the effect of anti-inflammatory diet on disease activity and quality of life in rheumatoid arthritis: the Anti-inflammatory Diet In Rheumatoid Arthritis (ADIRA) study protocol.
ABSTRACT: BACKGROUND:Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects 0.5-1.0% of the population, and where many patients in spite of modern pharmacological treatment fail to reach remission. This affects physical as well as mental wellbeing and leads to severely reduced quality of life and reduced work capacity, thus yielding high individual as well as societal costs. As a complement to modern pharmacological treatment, lifestyle intervention should be evaluated as a treatment option. Scientific evidence exists for anti-inflammatory effects by single foods on RA, but no study exists where these foods have been combined to obtain maximum effect and thus offer a substantial improvement in patient life quality. The main goal of the randomized cross-over trial ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis) is to test the hypothesis that an anti-inflammatory diet intervention, compared to a regular diet, will decrease disease activity and improve quality of life in patients with stable established RA. METHODS:In total, 50 RA patients with moderate disease activity are randomized to receive initially either a portfolio diet based on several food items with suggested anti-inflammatory effects or a control diet during 2?×?10 weeks with 3 months wash-out between diets. Food bags are delivered weekly by a home food delivery chain and referred to as the fiber bag and the protein bag, respectively, to partially blind participants. Both groups continue with regular pharmacological treatment. Known food biomarkers will be analyzed to measure intervention compliance. Impact on disease severity (measured by DAS28, a composite score which predicts disability and progression of RA), risk markers for cardiovascular disease and quality of life are evaluated after each diet regimen. Metabolomics will be used to evaluate the potential to predict responders to dietary treatment. A health economic evaluation is also included. DISCUSSION:The nutritional status of patients with RA often is poor and many ask their physician for diet advice. No evidence-based dietary guidelines for patients with RA exist because of the paucity of well-conducted sufficiently large diet intervention trials. ADIRA is an efficacy study and will provide evidence as to whether dietary treatment of RA can reduce disease activity and improve quality of life as well as reduce individual and societal costs. TRIAL REGISTRATION:ClinicalTrials.gov Registration Number: NCT02941055 .
Project description:BACKGROUND:Many patients with rheumatoid arthritis (RA) report symptom relief from certain foods. Earlier research indicates positive effects of food and food components on clinical outcomes in RA, but insufficient evidence exists to provide specific dietary advice. Food components may interact but studies evaluating combined effects are lacking. OBJECTIVES:We aimed to investigate if an anti-inflammatory diet reduces disease activity in patients with RA. METHODS:In this single-blinded crossover trial, 50 patients with RA were randomly assigned to an intervention diet containing a portfolio of suggested anti-inflammatory foods, or a control diet similar to the general dietary intake in Sweden, for 10 wk. After a 4-mo washout period the participants switched diet. Food equivalent to ?50% of energy requirements was delivered weekly to their homes. For the remaining meals, they were encouraged to consume the same type of foods as the ones provided during each diet. Primary outcome was change in Disease Activity Score in 28 joints-Erythrocyte Sedimentation Rate (DAS28-ESR). Secondary outcomes were changes in the components of DAS28-ESR (tender and swollen joints, ESR, and visual analog scale for general health) and DAS28-C-reactive protein. RESULTS:In the main analysis, a linear mixed ANCOVA model including the 47 participants completing ?1 diet period, there was no significant difference in DAS28-ESR between the intervention and control periods (P = 0.116). However, in unadjusted analyses, DAS28-ESR significantly decreased during the intervention period and was significantly lower after the intervention than after the control period in the participants who completed both periods (n = 44; median: 3.05; IQR: 2.41, 3.79 compared with median: 3.27; IQR: 2.69, 4.28; P = 0.04, Wilcoxon's Signed Rank test). No significant differences in the components were observed. CONCLUSIONS:This trial indicates positive effects of a proposed anti-inflammatory diet on disease activity in patients with RA. Additional studies are required to determine if this diet can cause clinically relevant improvements.This trial was registered at clinicaltrials.gov as NCT02941055.
Project description:Rheumatoid Arthritis (RA) is a chronic inflammatory disease. This study evaluates the effect of blue mussel intake on disease activity and quality of life in women with RA. Thirty-nine women with established RA and a disease activity score 28 (DAS28) >3.0 were recruited to a randomized 2 × 11-week cross-over dietary intervention. The participants continued with their medication and habitual diet and exchanged one cooked meal a day, five days a week, with a meal including 75 g blue mussels or 75 g meat. Diets were switched after an eight week washout period. Data regarding quality of life (SF-36), blood lipids, erythrocyte sediment rate (ESR), C-reactive protein (CRP) and tender and swollen joints were examined at the start and end of each dietary period. Thirty women completed one period, and twenty-three completed both. Intake of the blue mussel diet led to a significant reduction of DAS28-CRP (p = 0.048), but not DAS28. The number of EULAR (European League Against Rheumatism) criteria moderate and good responders were higher when consuming blue mussel diet (p = 0.036). Blood lipids did not change. To conclude, blue mussel intake reduced disease symptoms in women with RA and improved perceived health. The reported effects need to be confirmed by non-patient reported outcomes, such as inflammation markers.
Project description:<h4>Background</h4>The chronic inflammation in patients with rheumatoid arthritis (RA) increases the risk for cardiovascular diseases (CVD). The contribution of diet as a risk factor for CVD among these patients is however not fully understood. The aim of this study is to investigate if a proposed anti-inflammatory diet improves cardiovascular profile in weight stable patients with RA.<h4>Methods</h4>Patients (n?=?50) with RA were included in a cross-over trial. They were randomized to either a diet rich in whole grain, fatty fish, nuts, vegetables and fruit and supplemented with probiotics, or a control diet resembling average nutritional intake in Sweden, for ten weeks. After a 4-month washout they switched diet. Participants received food bags and dietary guidelines. Primary outcome was triglyceride (TG) concentration. Secondary outcomes were total-, high density lipoprotein- (HDL) and low density lipoprotein- (LDL) cholesterol, Apolipoprotein-B100 and -A1, lipoprotein composition, plasma phospholipid fatty acids and blood pressure.<h4>Results</h4>Forty-seven patients completed at least one period and they remained weight stable. There was a significant between-dietary treatment effect in TG and HDL-cholesterol concentration in favor of intervention (p?=?0.007 and p?=?0.049, respectively). Likewise, Apolipoprotein-B100/A1 ratio shifted toward a less atherogenic profile in favor of the intervention (p?=?0.007). Plasma fatty acids increased in polyunsaturated- and decreased in monounsaturated- and saturated fatty acids between diet periods in favor of the intervention period.<h4>Conclusion</h4>Blood lipid profile improved indicating cardioprotective effects from an anti-inflammatory dietary intervention in patients with RA.<h4>Trial registration</h4>This trial is registered at ClinicalTrials.gov as NCT02941055 .
Project description:The aim was to compile the evidence from Randomized Controlled Trials (RCTs) of diet or dietary supplements used to reduce disease activity in adults with Rheumatoid Arthritis (RA). Searches were performed in the databases PubMed, Scopus and Cochrane. Only RCT studies of diets, foods or dietary supplements, looking at effects on the Disease Activity Score in 28 joints (DAS28) among adults with RA, published in peer-reviewed journals, were included. A total of 27 articles were included-three of whole diets (Mediterranean diet, raw food and anti-inflammatory diet), five of food items, five of n-3 fatty acids, five of single micronutrient supplements, four of single antioxidant supplements and five of pre-, pro- or synbiotics. Studies that showed moderate strength evidence for positive effects on disease activity in RA included interventions with a Mediterranean diet, spices (ginger powder, cinnamon powder, saffron), antioxidants (quercetin and ubiquinone), and probiotics containing Lactobacillus Casei. Other diets or supplements had either no effects or low to very low strength of evidence. In conclusion, RCT studies on diet or dietary supplements are limited in patients with RA, but based on the results in this review there is evidence that some interventions might have positive effects on DAS28.
Project description:<h4>Background</h4> This study aims to analyze the effects of a potentially anti-inflammatory nutritional intervention in disease assessment parameters, inflammatory markers, and quality of life of fibromyalgia (FM) patients. <h4>Methods</h4> A sample of 100 female patients diagnosed with FM, followed up at Portuguese Institute of Rheumatology (IPR) in Lisbon, is being randomly allocated in two groups. Patients in the intervention group are adopting an anti-inflammatory diet, characterized by the exemption of the intake of foods containing gluten, dairy, sugar, and ultra-processed foods, during 3?months. During the first month, a low fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) diet is implemented, along with the anti-inflammatory diet, followed by the reintroduction of all fruits and vegetables over a consecutive period of 2?months. Patients in the control group are adopting a diet based on general recommendations for healthy eating. The outcomes are pain, fatigue, quality of sleep, quality of life, gastrointestinal symptoms, and inflammation. Before and after the 3?months intervention, and also 1?month after beginning the intervention, the following questionnaires are applied: Revised Fibromyalgia Impact Questionnaire, visual analog pain scale, Brief Pain Inventory,visual analog scale from a list of common gastrointestinal and extraintestinal symptoms in FM, Short Form 36, Fatigue Severity Survey, and Pittsburg Sleep Quality Index. Ultra-sensitive serum C-reactive protein, eritrocyte sedimentation rate, and interleukin-8 are determined. Age, physical activity, anthropometric parameters, and body composition are being collected. Student’s t test will assess the association between the disease evaluation parameters, the inflammatory markers, and the dietary interventions. <h4>Discussion</h4> The results of this study are expected to determine whether a change in patient nutrition helps to alleviate symptoms, which would optimize medical intervention. <h4>Trial registration</h4> www.ClinicalTrials.gov NCT04007705. Registered on July 5, 2019. <h4>Supplementary Information</h4> The online version contains supplementary material available at 10.1186/s13063-021-05146-3.
Project description:Rheumatoid arthritis (RA) is an autoimmune and inflammatory disease that can cause joint damage. Among the environmental risk factors, diet plays an important role because it can aggravate or attenuate inflammation. Selenium (Se) is considered an essential trace element since it is a structural component of antioxidant enzymes; however, its concentration can be affected by diet, drugs and genetic polymorphisms. Studies have reported that RA patients have a deficient diet in some food groups that is associated with parameters of disease activity. Furthermore, it has been shown that there is an alteration in serum Se levels in this population. Although some clinical trials have been conducted in the past to analyze the effect of Se supplementation in RA, no significant results were obtained. Contrastingly, experimental studies that have evaluated the effect of novel Se nanoparticles in RA-induced models have shown promising results on the restoration of antioxidant enzyme levels. In particular, glutathione peroxidase (GPx) is an important selenoprotein that could have a modulating effect on inflammation in RA. Considering that RA patients present an inflammatory and oxidative state, the aim of this review is to give an overview of the current knowledge about the relevance of Se status in RA.
Project description:OBJECTIVE:Our objective was to determine the impact of the Health Literacy Universal Precautions Toolkit, adapted for rheumatology, on medication adherence, patient satisfaction, and feasibility in all patients; its effect on the clinical disease activity index (CDAI) was studied in a rheumatoid arthritis (RA) subpopulation. METHODS:Data collected during a 6-month prospective quality assurance intervention was compared with data from a prior 6-month period. Interventions included 1) encouraging questions, 2) teach-back communication, and 3) brown-bag medication review. Analysis was performed using linear regression or generalized estimating equation (GEE) regression. RESULTS:During the intervention period, 46 physicians completed 1737 patient visits. Questions were encouraged, and teach-back communication was performed in more than 90% of visits. Brown-bag medication reviews were performed in 47% of visits overall and 69% of visits in a subgroup that received additional reminder calls. Visit duration and patient satisfaction were not significantly increased. Adherence for rheumatology-related medications that were prescribed both before and during the intervention increased by 22% (P ? 0.001; by GEE). Teach-back communication predicted a statistically significant improvement in medication adherence in this subpopulation (by linear regression). The mean CDAI did not improve; however, African American race and Hispanic ethnicity were associated with a decreased CDAI (by GEE). CONCLUSION:Implementation of the Health Literacy Universal Precautions Toolkit, adapted for rheumatology, improved medication adherence in our safety-net clinic, with particularly strong effects seen with teach-back communication. In certain populations, use of the toolkit may also improve RA disease activity. This is the first study to document improved medication adherence with this intervention in a real-world setting.
Project description:BACKGROUND:Parent-child diet quality resemblance is unknown in families of youth with type 1 diabetes, for whom nutrition is central to disease management. OBJECTIVE:Examine diet quality resemblance in families of youth with type 1 diabetes participating in a behavioral nutrition intervention trial and investigate whether treatment assignment or family meal frequency modifies resemblance. DESIGN:This is a secondary data analysis from an 18-month randomized controlled trial conducted August 2010 to May 2013. PARTICIPANTS/SETTING:Parent-youth dyads (N=136, child age=12.3±2.5 years) were recruited from a northeast US diabetes center. MAIN OUTCOME MEASURES:Parent and child Healthy Eating Index-2005 (HEI-2005, reflecting adherence to 2005 Dietary Guidelines for Americans) and whole plant food density (WPFD, reflecting intervention target foods) were calculated from 3-day food records collected every 6 months. STATISTICAL ANALYSIS:Linear random effects models adjusting for demographics and disease characteristics investigated parent-child diet quality resemblance. Separate models examined whether treatment assignment or family meal frequency modified resemblance. Three-way interaction terms examined whether resemblance changed over time by treatment assignment. RESULTS:Time-varying parent and child HEI-2005 and WPFD were positively associated (P<0.001), and there were no interactions with family meals. Parent-child HEI-2005 resemblance was similar across treatment groups; however, parent-child WPFD resemblance was stronger in the intervention (?±standard error [SE]=.30±.06) vs control families (?±SE=.12±.05). Parent-child HEI-2005 resemblance was similar over time by treatment assignment, whereas parent-child WPFD resemblance increased over time for families in the intervention group (three-way interaction term ?±SE=.03±.01). CONCLUSIONS:Parent and youth diet quality were positively correlated in families of youth with type 1 diabetes. Resemblance was stronger in the intervention group for target foods, but not for a general measure of diet quality. The lack of effect modification by family meal frequency suggests that family diet quality resemblance is not contingent on shared meals.
Project description:BACKGROUND:Children who are picky eaters typically demonstrate persistent food refusal and poor diet quality and may be resistant to intervention. OBJECTIVE:This study tested whether pickiness moderated the effect of a nutrition intervention on diet quality in youth with type 1 diabetes, hypothesizing that the intervention effect would be smaller among picky relative to nonpicky eaters. DESIGN:The study was an 18-month randomized clinical trial. PARTICIPANTS:Youth age 8.0 to 16.9 years (n=136) with type 1 diabetes duration ?1 year, receiving care at an outpatient diabetes center in Boston, MA, and a parent, participated from 2010 to 2013. INTERVENTION:The intervention integrated motivational interviewing, active learning, and applied problem solving to increase whole plant food intake. MAIN OUTCOME MEASURES:Whole plant food density (WPFD, cup/oz equivalents per 1,000 kcal target food groups), Healthy Eating Index-2005 (HEI2005, measures conformance to US dietary guidelines), and dietary variety were calculated from 3-day food records completed at six different times. Parents completed the pickiness subscale of the Child Feeding Questionnaire. STATISTICAL ANALYSES PERFORMED:Mean WPFD and HEI2005 were estimated using the population ratio method; standard errors were computed using jackknife variance-covariance estimation. Overall P value comparing groups across visits was derived using the ?2 test. RESULTS:Baseline diet quality was lower in picky than in nonpicky eaters. No intervention effect on pickiness or dietary variety was seen. In stratified analyses, the intervention effect on diet quality was significant for picky eaters only (WPFD P=0.0003; HEI2005 P=0.04). Among picky eaters, diet quality in the treatment group improved, whereas diet quality in the control group remained low. Diet quality of nonpicky eaters in the intervention group changed to a lesser degree. CONCLUSIONS:The intervention resulted in increased diet quality in picky eaters, whereas no intervention effect was seen in nonpicky eaters. Findings suggest that diet quality of picky eaters can be improved without changing their underlying pickiness.
Project description:Rheumatoid arthritis (RA) is a chronic, inflammatory rheumatic disease with the potential to induce significant disability. Patients with RA are at increased risk of cardiovascular diseases (CVD). Smokers with RA tend to experience more pain and fatigue, higher disease activity, more erosive joint destruction and a lower health-related quality of life (HR-QoL) than non-smokers. It remains to be determined whether these effects can be reduced by smoking cessation. This randomised controlled trial (RCT) in patients with RA aims to examine the effect of intensive smoking cessation intervention (motivational counselling combined with tailored nicotine replacement therapy) versus standard care on smoking cessation, and consequently on disease activity. Secondary objectives are to explore the effect on flare, risk factors for CVD, lung function, physical function, HR-QoL, pain and fatigue in patients with RA.This will be a multicentre, open label, two arm, parallel group, RCT, including 150 daily smokers with RA, being in remission or having low-moderate disease activity (DAS28 ≤ 5.1). The intervention group (n = 75) will receive five counselling sessions with a trained smoking cessation counsellor based on the principles of motivational counselling. Furthermore, intervention patients will be offered nicotine replacement therapy tailored to individual needs. Participants randomised to the control group will receive standard care. The co-primary outcome is a hierarchical endpoint, which will be evaluated at 3 months follow-up and will include (1) self-reported smoking cessation biochemically validated by exhaled carbon monoxide and (2) achievement of EULAR clinical response (an improvement in DAS28 of > 0.6). Follow-up visits will be performed at 3, 6 and 12 months post-intervention.This trial will reveal whether intensive smoking cessation counselling helps smokers with RA to achieve continuous smoking cessation and whether, as a concomitant benefit, it will reduce their RA disease activity. The trial aims to generate high quality evidence for the feasibility of a health promotion intervention for smokers with RA.ClinicalTrials.gov, identifier: NCT02901886 . Registered on 10 September 2016. Recruitment status updated on 10th October 2016.