Non-randomized Crossover Trial Research Articles

Post hoc analysis of food costs associated with Dietary Approaches to Stop Hypertension diet, whole food, plant-based diet, and typical baseline diet of individuals with insulin-treated type 2 diabetes mellitus in a nonrandomized crossover trial with meals provided

BackgroundAmericans consume diets that fall short of dietary recommendations, and the cost of healthier diets is often cited as a barrier to dietary change. We conducted a nonrandomized crossover trial with meals provided utilizing 2 diets: Dietary Approaches to Stop Hypertension (DASH) and whole food, plant-based (WFPB), and thus had intake data from baseline and both intervention diets. ObjectivesUsing actual diet records, describe food costs of baseline diets of individuals with type 2 diabetes (T2DM) as well as therapeutic DASH and WFPB diets. MethodsThree-day food records were collected and analyzed for each 7-d diet phase: baseline, DASH, and WFPB. Nutrient content was analyzed using the Nutrient Data System for Research and cost was determined using Fillet, an application to manage menu pricing. Food costs were calculated for each diet as consumed and adjusted to a standardized 1800 kcal/d. Ingredient-only costs of food away from home (FAFH) were approximated and analyzed. Costs were analyzed using linear mixed-effect models as a function of diet. ResultsFifteen subjects enrolled; 12 completed all dietary phases. The baseline, DASH, and WFPB diets, as consumed, cost $15.72/d (95% CI; $13.91, $17.53), $12.74/d ($11.23, $14.25), and $9.78/d ($7.97, $11.59), respectively. When adjusted to an 1800 kcal/d intake, the baseline, DASH, and WFPB diets cost $15.69/d ($13.87, $17.52), $14.92/d ($13.59, $16.26), and $11.96/d ($10.14, $13.78), respectively. When approximated ingredient-only costs of FAFH were analyzed, as consumed baseline [$11.01 ($9.53, $12.49)] and DASH diets [$11.81 ($10.44, $13.18)] had similar costs; WFPB diet [$8.83 ($7.35, $10.31)] cost the least. ConclusionsIn this short-term study with meals provided, the food costs of plant-predominant diets offering substantial metabolic health benefits were less than or similar to baseline food costs of adults with insulin-treated T2DM. Longer-term data without meal provision are needed for more generalizable results.This trial was registered at clinicaltrials.gov as NCT04048642.

The acute effects of a DASH diet and whole food, plant-based diet on insulin requirements and related cardiometabolic markers in individuals with insulin-treated type 2 diabetes

AimsThere is limited research regarding insulin dosing changes following adoption of plant-based diets. We conducted a nonrandomized crossover trial utilizing two plant-based diets (Dietary Approaches to Stop Hypertension, or DASH, and Whole Food, Plant-Based, or WFPB) to assess acute changes in insulin requirements and associated markers among individuals with insulin-treated type 2 diabetes. MethodsParticipants (n = 15) enrolled in a 4-week trial with sequential, one-week phases: Baseline, DASH 1, WFPB, and DASH 2. Each diet was ad libitum and meals were provided. ResultsCompared to baseline, daily insulin usage was 24%, 39%, and 30% lower after DASH 1, WFPB, and DASH 2 weeks respectively (all p < 0.01). Insulin resistance (HOMA-IR) was 49% lower (p < 0.01) and the insulin sensitivity index was 38% higher (p < 0.01) at the end of the WFPB week before regressing toward baseline during DASH 2. Total, LDL, and HDL cholesterol, leptin, urinary glucose, and hsCRP decreased to a nadir at the end of the WFPB week before increasing during DASH 2. ConclusionsAdopting a DASH or WFPB diet can result in significant, rapid changes in insulin requirements, insulin sensitivity, and related markers among individuals with insulin-treated type 2 diabetes, with larger dietary changes producing larger benefits.

Determination of an Acceptable Portion Size of Daal for a Bangladeshi Community-Based Iron Intervention in Adolescent Girls: A Feasibility Study.

Widely consumed daal (lentils) in Bangladesh are an ideal vehicle for iron (Fe) fortification; however, an acceptable portion size in meals needs to be determined to carry out a community feeding study in at-risk adolescent girls. A non-randomized crossover trial was conducted with n = 100 Bangladeshi girls (12.9 ± 2.0 years of age). Two recipes (thin and thick) and three portion sizes (25 g, 37.5 g, 50 g of raw lentil) of daal were served with 250 g of cooked white rice in a counter-balanced manner over 12 weeks. Each meal was fed to participants 5 days/week for two weeks. Ratings of hunger, satiety, and palatability were measured before and after each meal using Visual Analog Scales (VAS). The thick preparation in the 37.5 g portion (~200 g cooked) elicited higher VAS ratings of hunger, satiety, and palatability compared to all other meals. The 50 g portion of the thin preparation had VAS ratings similar to those of the 37.5 g thick preparation. Consuming the 37.5 g portion of fortified daal would provide 6.9 mg Fe/day to girls in a community-based effectiveness study. This would meet ~86% and ~46% of the Recommended Dietary Allowance (RDA) for Fe for girls aged 9–13 and 14–18 years, respectively.

Larviciding to prevent malaria transmission.

BackgroundLarviciding refers to the regular application of chemical or microbial insecticides to water bodies or water containers to kill the aquatic immature forms of the mosquito (the larvae and pupae).ObjectivesTo summarize research evidence evaluating whether larviciding with chemical or microbial insecticides prevents malaria transmission.Search methodsWe searched the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL), published in the Cochrane Library; MEDLINE; Embase; CAB s; LILACS; the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP); ClinicalTrials.gov; and the ISRCTN registry up to 6 June 2019.Selection criteriaWe included cluster‐randomized controlled trials (cRCTs), interrupted time series (ITS), randomized cross‐over studies, non‐randomized cross‐over studies, and controlled before‐and‐after studies (CBAs) that compared larviciding with no larviciding.Data collection and analysisWe independently assessed trials for eligibility and risk of bias, and extracted data. We assessed the certainty of evidence using the GRADE approach.Main resultsFour studies (one cRCT, two CBAs, and one non‐randomized cross‐over design) met the inclusion criteria. All used ground application of larvicides (people hand‐delivering larvicides); one evaluated chemical and three evaluated microbial agents. Studies were carried out in The Gambia, Tanzania, Kenya, and Sri Lanka. Three studies were conducted in areas where mosquito aquatic habitats were less extensive (< 1 km²), and one where habitats were more extensive (> 1 km²; a cross‐over study from The Gambia).For aquatic habitats of less than 1 km², one cRCT randomized eight villages in Sri Lanka to evaluate chemical larviciding using insect growth regulator; and two CBA studies undertaken in Kenya and Tanzania evaluated microbial larvicides. In the cRCT, larviciding across all villages was associated with lower malaria incidence (rate ratio 0.24, 4649 participants, low‐certainty evidence) and parasite prevalence (risk ratio (RR) 0.26, 5897 participants, low‐certainty evidence) compared to no larviciding. The two CBA studies reported lower malaria prevalence during the intervention period (parasite prevalence RR 0.79, 95% confidence interval (CI) 0.71 to 0.89; 70,902 participants; low‐certainty evidence). The Kenyan study also reported a reduction in the incidence of new malaria cases (RR 0.62, 95% CI 0.38 to 1.01; 720 participants; very low‐certainty evidence).For aquatic habitats of more than 1 km², the non‐randomized cross‐over trial using microbial larvicides did not detect an effect for malaria incidence (RR 1.58, 95% CI 0.94 to 2.65; 4226 participants), or parasite prevalence (RR 1.15, 95% CI 0.41 to 3.20; 3547 participants); both were very low‐certainty evidence. The Gambia trial also reported the mean haemoglobin level, and there was no difference across the four comparisons (mean difference –0.13, 95% CI –0.40 to 0.13; 3586 participants).We were unable to summarize or pool entomological outcomes due to unreported and missing data.Authors' conclusionsMost controlled studies on larviciding have been performed with microbial agents. Ground larviciding for non‐extensive larval habitats may have an effect on malaria transmission, and we do not know if there is an effect in large‐scale aquatic habitats. We found no studies using larviciding application techniques that could cover large aquatic habitats, such as aerial spraying using aircraft.16 September 2019Up to dateAll studies incorporated from most recent searchAll published trials found in the last search (6 Jun, 2019) were included, and we did not identify any ongoing trials.

A pilot study using "apps" as a novel strategy for the management of challenging behaviors seen in people living in residential care.

Many adults living in residential care will demonstrate challenging behaviors. Non-pharmacological strategies are recommended as first-line treatment. Using applications (apps) is a novel approach to managing these behaviors, and has yet to be assessed in this group. This paper describes a pilot study to test apps as a novel non-pharmacological strategy to manage challenging behaviors in adults living in residential care. A non-blinded, non-randomized crossover trial design was implemented which compared apps to a control situation and usual care to determine whether apps were able to decrease challenging behaviors. The primary outcome measure was the Neuropsychiatric Inventory (NPI) that measures the frequency and severity of these behaviors. Fifteen residents participated whose mean age was 78.5 years. There were a range of diagnoses and comorbidities, including dementia and schizophrenia. IPads were used as the medium for delivering the apps and residential care staff implemented the interventions. There was a significant decrease in the total NPI score using the apps intervention (10.6 points) compared to the control (17.7 points) and to usual care (21.1 points). There was positive qualitative feedback from the staff who were involved in the study, but they also cited barriers such as lack of confidence using the apps and lack of time. Although this was a small and limited study, results suggest that using apps may be a feasible and personalized approach to managing challenging behaviors. A more rigorous study design that includes larger sample sizes and staff training may enable further research and benefits in this area.

Asynchrony, neural drive, ventilatory variability and COMFORT: NAVA versus pressure support in pediatric patients. A non-randomized cross-over trial

PurposeTo determine if neurally adjusted ventilatory assist (NAVA) improves asynchrony, ventilatory drive, breath-to-breath variability and COMFORT score when compared to pressure support (PS).MethodsThis is a non-randomized short-term cross-over trial in which 12 pediatric patients with asynchrony (auto-triggering, double triggering or non-triggered breaths) were enrolled. Four sequential 10-min periods of data were recorded after 20 min of ventilatory stabilization (wash-out) at each of the following settings: baseline PS with the ventilator settings determined by the attending physician (1-PSb); PS after optimization (2-PSopt); NAVA level set so that maximum inspiratory pressure (P max) equaled P max in PS (3-NAVA); same settings as in 2-PSopt (4-PSopt).ResultsThe median asynchrony index was significantly lower during NAVA (2.0 %) than during 2-PSopt (8.5 %, p = 0.017) and 4-PSopt (7.5 %, p = 0.008). In NAVA mode, the NAVA trigger accounted on average for 66 % of triggered breaths. The median trigger delay with respect to neural inspiratory time was significantly lower during NAVA (8.6 %) than during 2-PSopt (25.2 %, p = 0.003) and 4-PSopt (28.2 %, p = 0.0005). The median electrical activity of the diaphragm (EAdi) change during trigger delay normalized to maximum inspiratory EAdi difference was significantly lower during NAVA (5.3 %) than during 2-PSopt (21.7 %, p = 0.0005) and 4-PSopt (24.6 %, p = 0.001). The coefficient of variation of tidal volume was significantly higher during NAVA (44.2 %) than during 2-PSopt (19.8 %, p = 0.0002) and 4-PSopt (23.0 %, p = 0.0005). The median COMFORT score during NAVA (15.0) was lower than that during 2-PSopt (18.0, p = 0.0125) and 4-PSopt (17.5, p = 0.039). No significant changes for any variable were observed between 1-PSb and 2-PSopt.ConclusionsNeurally adjusted ventilatory assist as compared to optimized PS results in improved synchrony, reduced ventilatory drive, increased breath-to-breath mechanical variability and improved patient comfort.Electronic supplementary materialThe online version of this article (doi:10.1007/s00134-012-2535-y) contains supplementary material, which is available to authorized users.

Antialbuminuric advantage of cilnidipine compared with L-type calcium channel blockers in type 2 diabetic patients with normoalbuminuria and microalbuminuria

We evaluated the antialbuminuric advantage of cilnidipine, an N/L-type calcium channel blocker (CCB), compared with L-type CCBs in diabetic patients with normoalbuminuria and microalbuminuria. The study was a multicenter, non-randomized crossover trial. Participants were 90 type 2 diabetic patients exhibiting either normo- or microalbuminuria, and undergoing CCB treatment for ≥6 months prior to study entry. The CCB at the time of entry was continued for the first 6 months (Period 1). Treatment was subsequently switched from cilnidipine to an L-type CCB, or vice versa, for the second 6-month observation period (Period 2). During Period 1, the L-type CCB group showed a significant increase of urinary albumin excretion (UAE) over time, while the cilnidipine group showed no significant elevation. During Period 2, switching of the treatment from the L-type CCB to cilnidipine resulted in significant reduction of the UAE, whereas switching from cilnidipine to the L-type CCB resulted in no significant change in the UAE. This study demonstrated that the antialbuminuric effect of Cilnidipine, but not the L-type CCBs, was sustained even in patients treated for a long time. In addition, the antialbuminuric effect can be anticipated after switching from an L-type CCB to cilnidipine, but not vice versa.

Sage Tea Drinking Improves Lipid Profile and Antioxidant Defences in Humans

Salvia officinalis (common sage) is a plant with antidiabetic properties. A pilot trial (non-randomized crossover trial) with six healthy female volunteers (aged 40–50) was designed to evaluate the beneficial properties of sage tea consumption on blood glucose regulation, lipid profile and transaminase activity in humans. Effects of sage consumption on erythrocytes’ SOD and CAT activities and on Hsp70 expression in lymphocytes were also evaluated. Four weeks sage tea treatment had no effects on plasma glucose. An improvement in lipid profile was observed with lower plasma LDL cholesterol and total cholesterol levels as well as higher plasma HDL cholesterol levels during and two weeks after treatment. Sage tea also increased lymphocyte Hsp70 expression and erythrocyte SOD and CAT activities. No hepatotoxic effects or other adverse effects were observed.