Effect of dairy products on oxidative stress in type 2 diabetic patients: A randomized controlled clinical trial

ObjectiveThe aim of this randomized control trial was to assess the effect of dairy product (milk and yogurt) consumption on oxidative stress biomarkers in diabetic patients.Material and methodsNinety-one diabetic patients were randomly assigned to one of the three following intervention groups: group A (<1 serving of dairy products), group B (2 to 3 servings), and group C (4 to 5 servings). Biomarkers of oxidative stress including, serum total antioxidant capacity, catalase activity, malondialdehyde (MDA) were measured at baseline and after the 8-week intervention.ResultsNo significant difference was found in oxidative stress between groups, except for MDA that significantly decreased in group C.ConclusionsConsumption of dairy products including milk and yogurt, ≥ 4 servings per day, reduced MDA concentration, however consumption ≤ 3 serving per day had no significant effect on oxidative stress among diabetic patients.     

Intake of a protein-enriched milk and effects on muscle mass and strength. A 12-week randomized placebo controlled trial among community-dwelling older adults

Objectives

To investigate the effect of 20 g protein with breakfast and evening meal on muscle mass, muscle strength and functional performance in older adults.

Design

A double-blinded randomized controlled study.

Setting

Oslo and Akershus University College of Applied Sciences, Norway.

Participants

Healthy community-dwelling men and women (≥ 70 years) with reduced physical strength and/or performance.

Intervention

Subjects were randomly assigned to receive either protein-enriched milk (2 x 0.4 L/d; protein group) or an isocaloric carbohydrate drink (2 x 0.4 L/d; control group) with breakfast and evening meal for 12 weeks.

Measurements

The primary endpoints were muscle mass measured by dual X-ray absorptiometry, and tests of muscle strength (one repetition maximum test of chest press and leg press) and functional performance (handgrip strength, stair climb and repeated chair rise).

Results

In total, 438 subjects were screened, 50 subjects were randomized and 36 completed the study. Chest press improved significantly in the protein (1.3 kg (0.1-2.5), p=0.03) and the control group (1.5 kg (0.0-3.0), p=0.048), but with no difference between the groups (p=0.85). No significant change in leg press (p=0.93) or muscle mass (p=0.54) were observed between the protein and the control group. Nor did we observe any significant differences in the functional performance tests (p>0.05 for all tests) between the groups.

Conclusion

Increased protein intake (2 x 20 g/d) did not significantly improve muscle mass, muscle strength or functional performance in healthy older weight stable adults. Whether intake of > 20 g protein to each meal is necessary for preservation of muscle mass and strength in older adults should be further investigated in a larger study. This underscores the need for well-designed studies that can differentiate between the effect of protein intake and increased energy. This trial was registered at Clinicaltrials.gov (ID no. NCT02218333).

     

Effects of nutritional supplements on muscle mass and activities of daily living in elderly rehabilitation patients with decreased muscle mass: A randomized controlled trial

Objective

To investigate the effects of nutritional intervention with resistance training on skeletal muscle mass in elderly patients with disabilities in a convalescent rehabilitation setting.

Design

A randomized controlled trial. (UMIN Clinical Trials Registry ID: UMIN000006238).

Setting

A rehabilitation hospital.

Participants

39 elderly patients with decreased skeletal muscle mass in an inpatient convalescence rehabilitation unit.

Interventions

A combination of resistance training plus nutritional supplementation (R/N group) or resistance training alone (R group). The training and supplementation were conducted essentially from the patient’s admission to discharge (2–6 months).

Outcome Measures

The patients were evaluated at the time of admission and at the end of the intervention for skeletal muscle mass (calf circumference [CC] as a primary outcome, and arm circumference [AC]), hand grip strength (HG), Mini-Nutritional Assessment-Short Form (MNA®-SF) score, serum albumin level (Alb), body mass index (BMI), and activities of daily living (ADL) as represented by the Barthel Index (BI) score.

Results

Significant treatment effects were seen for CC, AC, BI, Alb in the R/N group compared to the R group. A mean treatment effect of 3.2 (95%CI: 2.0–4.4) was seen in CC, 1.4 (95%CI: 0.8–2.1) was seen in AC, 11.2 (95%CI: 0.5–21.8) was seen in BI, 0.3 (95%CI: 0.1–0.5) was seen in Alb.

Conclusion

The results of this study suggest that nutritional intervention added to resistance training during convalescent rehabilitation may improve skeletal muscle mass and activities of daily living.

     

Effects of Capoeira on children's executive functions: A randomized controlled trial

PurposeA growing body of evidence suggests that the benefits of exercise go far beyond physical health and may include cognitive gains. Capoeira is an Afro-Brazilian martial art that challenges Executive Functions (EFs), and inspires children's commitment in an environment characterized by positive affect, inclusiveness, and camaraderie. The primary aim of the study was to evaluate the effect of Capoeira on EFs in children. The secondary aims were to look at the effects of Capoeira on academic achievement and motor function and to look at dose-response effects of Capoeira on EF.MethodsIn this randomized controlled trial, 67 children (aged 8–13 years) were randomly assigned to Capoeira instruction (n = 37) or a wait-list control group (n = 30). Children in the Capoeira group participated in 60-min Capoeira classes three times per week. The Stroop Test, EF subtests of the Wechsler Intelligence Scale for Children, an Academic Achievement Test, agility and eye-hand coordination tests were conducted before and after the intervention period.ResultsANCOVA analyses, controlling for sex and age, revealed that children who attended at least 70% of the Capoeira classes improved more in eye-hand coordination than the control group. There was also a positive association between EF improvement and the number of Capoeira classes attended.ConclusionThe results suggest that Capoeira practice benefits eye-hand motor coordination in children and that the improvements in EFs might be dose-dependent. The results highlight the need for further studies to determine the potential advantages of adopting Capoeira as a holistic movement practice for children.     

Low anthocyanin plum nectar does not impact cognition,blood pressure and gut microbiota in healthy older adults: A randomized crossover trial

Queen Garnet plum (QGP), known for its high levels of anthocyanins, is a hybrid of the Japanese plum developed in Queensland, Australia. Anthocyanins provide the red, blue, and purple pigments in plants with demonstrated beneficial health effects. This study hypothesized that low-dose anthocyanin QGP intake will have a significant positive effect on cognition, blood pressure, and gut microbiota in healthy older adults. A randomized crossover trial was conducted to determine the effect and within subject variance on cognition and 24 hr. ambulatory blood pressure in older adults without cognitive impairment following daily consumption of 200 mL low-dose anthocyanin (5 mg/100 g) QGP nectar (intervention) or raspberry cordial (control). Secondary outcomes included inflammatory markers (C-reactive protein), nerve growth factor (BDNF), and gut microbiota (16S rRNA gene sequencing). Twenty-eight participants (55+ years) were recruited. Each randomized treatment arm lasted for 8 weeks with a 4-week washout period. Cognition, blood pressure, and urine samples were measured at each visit (5 total) while blood and fecal samples were collected at baseline, 8 weeks, and 20 weeks. Repeated-measures ANOVA was used to analyze the data. Across the treatments, no significant difference was observed for the different domains of cognition, blood pressure, or anti-inflammatory biomarkers. No intervention effect was found for genera or class of gut microbes. Low anthocyanin nectar derived from the QGP did not have any significant effects on cognition, blood pressure, or gut microbiota in healthy older adults.     

Biological effects of a dietary omega-3 polyunsaturated fatty acids supplementation in cystic fibrosis patients: a randomized, crossover placebo-controlled trial

BACKGROUND AND AIMS: Various anti-inflammatory therapies, including dietary omega-3 polyunsaturated fatty acids (PUFA) supplementation, have been investigated in cystic fibrosis (CF) patients. To further explore this nutritional approach, biological effects of an omega-3 PUFA oral liquid supplementation were measured in 17 CF patients in a double-blind, randomized, crossover without a washout period and placebo-controlled study. METHODS: CF patients (age: 18+/-9 year; weight: 43+/-13 kg) received a liquid dietary supplementation either enriched or not in omega-3 PUFA (390-1170 mg/day according to patient weight) during two 6-month periods. RESULTS: Increase in eicosapentaenoic acid was observed in neutrophil membrane following omega-3 PUFA dietary supplementation (from 0.7+/-0.6 to 1.6+/-0.6 micromol%, P<0.01). The leukotriene B(4) (LTB(4))/leukotriene B(5) (LTB(5)) ratio was decreased (from 72+/-27 to 24+/-7, P<0.001) in CF patients taking omega-3 PUFA supplements. In contrast, omega-3 PUFA supplementation affected neither internalization of IL-8 receptors following IL-8 exposure, nor IL-8-induced neutrophil chemotaxis. CONCLUSION: Our results show that omega-3 PUFA are incorporated in neutrophil membranes. The subsequent decrease in LTB(4)/LTB(5) ratio suggests that, in such conditions, neutrophils may produce less pro-inflammatory mediators from the acid arachidonic pathway. These data indicate that omega-3 PUFA intake may have anti-inflammatory effect that still need to be assessed by long-term studies following large groups of patients.     

The acceptability of the female and male condom: a randomized crossover trial

CONTEXT: Although studies have assessed the acceptability of male and female condoms, comparative trial data are lacking. METHODS: A sample of 108 women in stable relationships recruited from an urban, reproductive health clinic were randomly assigned to use 10 male or female condoms, followed by use of 10 of the other type. A nurse provided instruction in correct method use. Demographic information was collected in a baseline questionnaire; acceptability data were collected in follow-up and exit questionnaires and coital logs. Nonparametric and chi-square statistics were used to analyze measures of the methods' relative acceptability. Bowker's test of symmetry was adapted to test the null hypothesis of no difference in acceptability between condom types. RESULTS: Participants used 678 female and 700 male condoms. Although neither method scored high on user satisfaction measures, the 63 women completing the study protocol preferred the male condom to the female condom for ease of application or insertion, ease of removal, general fit, feel of the condom during intercourse and ease of penetration. Participants reported that their partner also favored the male condom, although women generally appeared to like this method more than their partner did. In a direct comparison between the methods at the end of the study, women generally judged male condoms superior on specified preference criteria. CONCLUSIONS: Across a range of criteria, the female condom was less acceptable than the male condom to most women and their partners. Although both types had low acceptability, they are needed and valid methods of pregnancy and disease prevention. That neither rated high on user satisfaction measures underscores the need for more barrier methods that women and men can use.     

A randomized trial to reduce the prevalence of depression and self-harm behavior in older primary care patients

PURPOSE

We wanted to determine whether an educational intervention targeting general practitioners reduces the 2-year prevalence of depression and self-harm behavior among their older patients.

METHODS

Our study was a cluster randomized controlled trial conducted between July 2005 and June 2008. We recruited 373 Australian general practitioners and 21,762 of their patients aged 60 years or older. The intervention consisted of a practice audit with personalized automated audit feedback, printed educational material, and 6 monthly educational newsletters delivered over a period of 2 years. Control physicians completed a practice audit but did not receive individualized feedback. They also received 6 monthly newsletters describing the progress of the study, but they were not offered access to the educational material about screening, diagnosis and management of depression, and suicide behavior in later life. The primary outcome was a composite measure of clinically significant depression (Patient Health Questionnaire score ≥10) or self-harm behavior (suicide thoughts or attempt during the previous 12 months). Information about the outcomes of interest was collected at the baseline assessment and again after 12 and 24 months. We used logistic regression models to estimate the effect of the intervention in a complete case analysis and intention-to-treat analysis by imputed chain equations (primary analysis).

RESULTS

Older adults treated by general practitioners assigned to the intervention experienced a 10% (95% CI, 3%–17%) reduction in the odds of depression or self-harm behavior during follow-up compared with older adults treated by control physicians. Post hoc analyses showed that the relative effect of the intervention on depression was not significant (OR = 0.93; 95% CI, 0.83–1.03), but its impact on self-harm behavior over 24 months was (OR = 0.80; 95% CI, 0.68–0.94). The beneficial effect of the intervention was primarily due to the relative reduction of self-harm behavior among older adults who did not report symptoms at baseline. The intervention had no obvious effect in reducing the 24-month prevalence of depression or self-harm behavior in older adults who had symptoms at baseline.

CONCLUSIONS

Practice audit and targeted education of general practitioners reduced the 2-year prevalence of depression and self-harm behavior by 10% compared with control physicians. The intervention had no effect on recovery from depression or self-harm behavior, but it prevented the onset of new cases of self-harm behavior during follow-up. Replication of these results is required before we can confidently recommend the roll-out of such a program into normal clinical practice.     

Efficacy of transdermal clonidine for headache prophylaxis and reduction of narcotic use in migraine patients. A randomized crossover trial

Thirty patients completed a double-blind, randomized crossover study utilizing transdermal clonidine and an identical-appearing placebo. Crossover occurred at 6 weeks, with a total study time of 12 weeks. Subjects were asked to record daily in a special diary (1) the presence or absence of headache, (2) duration of headache, (3) severity of headache, and (4) use of pain medication for headache relief. The severity of the headaches was rated from 1 (very mild) to 5 (very severe). Although the subjects reported a decrease in frequency, duration, and intensity of headaches while using the medicated patch, these differences did not reach statistical significance. Nineteen patients subjectively preferred the medicated patch, while five preferred the placebo (P less than .01). During use of the medicated patch, a significant reduction (P = .039) occurred in use of class II narcotics. Three doses of these substances were used by the patients when treated with clonidine, while 34 doses were taken during placebo use. These findings suggest that clonidine might have a role in reduction of parenteral narcotic use in acute pain syndromes.