Snacking, Satiety, and Weight: A Randomized, Controlled Trial.

PURPOSE: To compare the effects of nut-based snack bars (NBSB) vs. prepackaged 200-kcal portions of typical conventional snack foods, when consumed over a 12-week period by a group of overweight adults. DESIGN: Randomized, single-blind parallel design with two treatment groups. SUBJECTS: Thirty-four overweight participants were enrolled. INTERVENTION: Commercially available NBSB or conventional snack foods as part of an ad libitum diet for 12 weeks. PRIMARY OUTCOME MEASURES: body mass index, body weight, body composition, waist circumference. SECONDARY OUTCOME MEASURES: blood pressure, lipid profile, nutrients intake, hunger/satiety, quality of life. ANALYSIS: Generalized linear models with time as repeated measure were used to analyze these data. RESULTS: Daily consumption of NBSB for 12 weeks, as compared to daily consumption of conventional snacks, significantly reduced percentage body fat (-1.7% ± 10.8% vs. 6.2% ± 9.3%; p = .04) and visceral fat (-1.3 ± 5.9 vs. 2.7 ± 4.0; p = .03). There were no between-group differences (p > .05) for blood pressure, lipid panel, satiety, or quality of life measures. CONCLUSION: Our data suggest that daily consumption of NBSB for 12 weeks reduced body fat and had no adverse effects on weight, blood pressure, lipid profile, satiety, or quality of life in this small sample of overweight adults.

Inclusion of walnut in the diets of adults at risk for type 2 diabetes and their dietary pattern changes: a randomized, controlled, cross-over trial.

BACKGROUND: In our recently published study, including walnuts in the diets of adults with prediabetes led to overall improvement in diet quality. This report adds to those study findings by examining the food groups displaced during walnut inclusion in the diets of those adults with prediabetes. METHODS: Randomized, controlled, modified Latin square parallel design with 2 treatment arms. The 112 participants (31 men, 81 women) were randomly assigned to a diet with or without dietary counseling to regulate calorie intake in a 1:1 ratio. Within each treatment arm, participants were further randomized to 1 of 2 sequence permutations to receive a walnut-included diet with 56 g (366 kcal) of walnuts per day and a walnut-excluded diet. Participants in the calorie-regulated arm received advice from a dietitian to preserve an isocaloric condition while including walnuts. We analyzed the 12 components of the 2010 Healthy Eating Index to examine dietary pattern changes of study participants. RESULTS: Seafood and plant protein foods intake significantly increased with walnut inclusion, compared with their exclusion (2.14±2.06 vs -0.49±2.33; p=0.003). The ingestion of healthful fatty acids also significantly increased with walnut inclusion, compared with their exclusion (1.43±4.53 vs -1.76±4.80; p=0.02). Dairy ingestion increased with walnut inclusion in the calorie-regulated phase, compared with walnut inclusion without calorie regulation (1.06±4.42 vs -2.15±3.64; p=0.02). CONCLUSIONS: Our data suggest that walnut inclusion in the diets of adults at risk for diabetes led to an increase in intake of other healthful foods. TRIAL REGISTRATION NUMBER: NCT02330848.

Snack Food, Satiety, and Weight.

In today's society, snacking contributes close to one-third of daily energy intake, with many snacks consisting of energy-dense and nutrient-poor foods. Choices made with regard to snacking are affected by a multitude of factors on individual, social, and environmental levels. Social norms, for example, that emphasize healthful eating are likely to increase the intake of nutrient-rich snacks. In addition, satiety, the feeling of fullness that persists after eating, is an important factor in suppressing overconsumption, which can lead to overweight and obesity. Thus, eating snacks between meals has the potential to promote satiety and suppress overconsumption at the subsequent meal. Numerous studies have explored the relation between snack foods and satiety. These studies concluded that whole foods high in protein, fiber, and whole grains (e.g., nuts, yogurt, prunes, and popcorn) enhance satiety when consumed as snacks. Other foods that are processed to include protein, fiber, or complex carbohydrates might also facilitate satiety when consumed as snacks. However, studies that examined the effects of snack foods on obesity did not always account for satiety and the dietary quality and portion size of the snacks consumed. Thus, the evidence concerning the effects of snack foods on obesity has been mixed, with a number of interventional and observational studies not finding a link between snack foods and increased weight status. Although further prospective studies are warranted to conclusively determine the effects of snack foods on obesity risk, the consumption of healthful snacks likely affects satiety and promotes appetite control, which could reduce obesity.

Walnut ingestion in adults at risk for diabetes: effects on body composition, diet quality, and cardiac risk measures.

BACKGROUND: Despite their energy density, walnuts can be included in the diet without adverse effects on weight or body composition. The effect of habitual walnut intake on total calorie intake is not well studied. Effects on overall diet quality have not been reported. METHODS: Randomized, controlled, modified Latin square parallel design study with 2 treatment arms. The 112 participants were randomly assigned to a diet with or without dietary counseling to adjust calorie intake. Within each treatment arm, participants were further randomized to 1 of the 2 possible sequence permutations to receive a walnut-included diet with 56 g (providing 366 kcal) of walnuts per day and a walnut-excluded diet. Participants were assessed for diet quality, body composition, and cardiac risk measures. RESULTS: When compared with a walnut-excluded diet, a walnut-included diet for 6 months, with or without dietary counseling to adjust caloric intake, significantly improved diet quality as measured by the Healthy Eating Index 2010 (9.14±17.71 vs 0.40±15.13; p=0.02 and 7.02±15.89 vs -5.92±21.84; p=0.001, respectively). Endothelial function, total and low-density lipoprotein (LDL) cholesterol improved significantly from baseline in the walnut-included diet. Body mass index, percent body fat, visceral fat, fasting glucose, glycated hemoglobin, and blood pressure did not change significantly. CONCLUSIONS: The inclusion of walnuts in an ad libitum diet for 6 months, with or without dietary counseling to adjust calorie intake, significantly improved diet quality, endothelial function, total and LDL cholesterol, but had no effects on anthropometric measures, blood glucose level, and blood pressure. TRIAL REGISTRATION NUMBER: NCT02330848.

Effects of a cognitive-behavioral therapy-based immersion obesity treatment program for adolescents on weight, fitness, and cardiovascular risk factors: a pilot study.

BACKGROUND: Comprehensive, residential treatment for severe obesity in adolescents may be an alternative to bariatric surgery and more efficacious than outpatient treatment. The aim of this study was to evaluate the effects of a long-term cognitive-behavioral therapy-based immersion obesity treatment program for adolescents. METHODS: Twelve obese adolescents with BMIs above the 95th percentile completed a 14- to 18-week multicomponent intervention. RESULTS: We observed significant improvements in BMI z-score, waist circumference, mile run time, and blood lipids. CONCLUSION: This study suggests that the tested program may be effective, at least in the short term; a randomized, controlled trial to further assess this model is warranted.

Effects of egg ingestion on endothelial function in adults with coronary artery disease: a randomized, controlled, crossover trial.

BACKGROUND: Prevailing recommendations call for restricting intake of dietary cholesterol and eggs for those at risk of heart disease, despite accumulating evidence challenging this association. Our prior studies showed no short-term adverse effects of daily egg intake on cardiac risk factors in at-risk adults. OBJECTIVE: We conducted this study to determine effects of daily egg consumption in adults with established coronary artery disease (CAD). METHODS: Randomized, controlled, single-blind, crossover trial of 32 adults (mean age, 67 years; 6 women, 26 men) with CAD assigned to 1 of 6 possible sequence permutations of 3 different treatments (breakfast with 2 eggs, breakfast with ½ cup Egg Beaters, ConAgra Foods, St. Louis, MO, or a high-carbohydrate breakfast part of an ad libitum diet) for 6 weeks, with 4-week washout periods. The primary outcome measure was endothelial function measured as flow-mediated dilatation. RESULTS: Compared with the control breakfast (ie, high-carbohydrate breakfast), daily consumption of eggs showed no adverse effects on flow-mediated dilatation (7.2% ± 2.9% vs 7.5% ± 2.9%, P = .33), lipids (total cholesterol: 158.3 ± 28.6 mg/dL vs 156.2 ± 27.4 mg/dL, P = .49), blood pressure (systolic blood pressure: 132.8 ± 14.1 mm Hg or vs 135.5 ± 14.9 mm Hg, P = .52; diastolic blood pressure: 77.2 ± 6.1 mm Hg vs 76.7 ± 6.9 mm Hg, P = .86), or body weight (90.8 ± 17.5 kg vs 91.8 ± 17.1 kg, P = .92). No outcomes differed (P > .05) between eggs and Egg Beaters. CONCLUSIONS: We found no evidence of adverse effects of daily egg ingestion on any cardiac risk factors in adults with CAD over a span of 6 weeks.

Massage therapy for osteoarthritis of the knee: a randomized dose-finding trial.

BACKGROUND: In a previous trial of massage for osteoarthritis (OA) of the knee, we demonstrated feasibility, safety and possible efficacy, with benefits that persisted at least 8 weeks beyond treatment termination. METHODS: We performed a RCT to identify the optimal dose of massage within an 8-week treatment regimen and to further examine durability of response. Participants were 125 adults with OA of the knee, randomized to one of four 8-week regimens of a standardized Swedish massage regimen (30 or 60 min weekly or biweekly) or to a Usual Care control. Outcomes included the Western Ontario and McMaster Universities Arthritis Index (WOMAC), visual analog pain scale, range of motion, and time to walk 50 feet, assessed at baseline, 8-, 16-, and 24-weeks. RESULTS: WOMAC Global scores improved significantly (24.0 points, 95% CI ranged from 15.3-32.7) in the 60-minute massage groups compared to Usual Care (6.3 points, 95% CI 0.1-12.8) at the primary endpoint of 8-weeks. WOMAC subscales of pain and functionality, as well as the visual analog pain scale also demonstrated significant improvements in the 60-minute doses compared to usual care. No significant differences were seen in range of motion at 8-weeks, and no significant effects were seen in any outcome measure at 24-weeks compared to usual care. A dose-response curve based on WOMAC Global scores shows increasing effect with greater total time of massage, but with a plateau at the 60-minute/week dose. CONCLUSION: Given the superior convenience of a once-weekly protocol, cost savings, and consistency with a typical real-world massage protocol, the 60-minute once weekly dose was determined to be optimal, establishing a standard for future trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT00970008.

Effects of walnuts on endothelial function in overweight adults with visceral obesity: a randomized, controlled, crossover trial.

OBJECTIVES: Metabolic syndrome is a precursor of diabetes and cardiovascular disease (CVD). Walnut ingestion has been shown to reduce CVD risk indices in diabetes. This randomized controlled crossover trial was performed to investigate the effects of daily walnut consumption on endothelial function and other biomarkers of cardiac risk in a population of overweight individuals with visceral adiposity. METHODS: Forty-six overweight adults (average age, 57.4 years; 28 women, 18 men) with elevated waist circumference and 1 or more additional signs of metabolic syndrome were randomly assigned to two 8-week sequences of walnut-enriched ad libitum diet and ad libitum diet without walnuts, which were separated by a 4-week washout period. The primary outcome measure was the change in flow-mediated vasodilation (FMD) of the brachial artery. Secondary measures included serum lipid panel, fasting glucose and insulin, Homeostasis Model Assessment-Insulin Resistance values, blood pressure, and anthropometric measures. RESULTS: FMD improved significantly from baseline when subjects consumed a walnut-enriched diet as compared with the control diet (1.4% ± 2.4% versus 0.3% ± 1.5%; p = 0.019). Beneficial trends in systolic blood pressure reduction were seen, and maintenance of the baseline anthropometric values was also observed. Other measures were unaltered. CONCLUSION: Daily ingestion of 56 g of walnuts improves endothelial function in overweight adults with visceral adiposity. The addition of walnuts to the diet does not lead to weight gain. Further study of the potential role of walnut intake in diabetes and CVD prevention is warranted.

Effects of sugar-sweetened and sugar-free cocoa on endothelial function in overweight adults.

BACKGROUND: Studies of cocoa suggest an array of cardiovascular benefits; however, the effects of daily intake of sugar-free and sugar-sweetened cocoa beverages on endothelial function (EF) have yet to be established. METHODS: 44 adults (BMI 25-35 kg/m2) participated in a randomized, controlled, crossover trial. Participants were randomly assigned to a treatment sequence: sugar-free cocoa beverage, sugar-sweetened cocoa beverage, and sugar-sweetened cocoa-free placebo. Treatments were administered daily for 6 weeks, with a 4-week washout period. RESULTS: Cocoa ingestion improved EF measured as flow-mediated dilation (FMD) compared to placebo (sugar-free cocoa: change, 2.4% [95% CI, 1.5 to 3.2] vs. -0.8% [95% CI, -1.9 to 0.3]; difference, 3.2% [95% CI, 1.8 to 4.6]; p<0.001 and sugar-sweetened cocoa: change, 1.5% [95% CI, 0.6 to 2.4] vs. -0.8% [95% CI, -1.9 to 0.3]; difference, 2.3% [95% CI, 0.9 to 3.7]; p=0.002). The magnitude of improvement in FMD after consumption of sugar-free versus sugar-sweetened cocoa was greater, but not significantly. Other biomarkers of cardiac risk did not change appreciably from baseline. BMI remained stable throughout the study. CONCLUSIONS: Daily cocoa ingestion improves EF independently of other biomarkers of cardiac risk, and does not cause weight gain. Sugar-free preparations may further augment endothelial function.

A pilot study of chromium picolinate for weight loss.

BACKGROUND: Chromium is an essential trace element and nutritional supplement that has garnered interest for use as a weight loss aid. OBJECTIVE: This trial assesses the effects of chromium picolinate supplementation, alone and combined with nutritional education, on weight loss in apparently healthy overweight adults. DESIGN: This was a randomized, double-blind, placebo-controlled trial of 80 otherwise healthy, overweight adults assessed at baseline for central adiposity measured by computerized tomography. Subjects were randomly assigned to daily ingestion of 1000 microg of chromium picolinate or placebo for 24 weeks. All subjects received passive nutritional education at the 12-week point in both the intervention and control groups. Outcomes include weight, height, blood pressure, percent body fat, serum, and urinary biomarkers. RESULTS: At baseline, both the chromium and placebo groups had similar mean body mass index (BMI) (chromium = 36 +/- 6.7 kg/m(2) versus placebo = 36.1 +/- 7.6 kg/m(2); p = 0.98). After 12 weeks, no change was seen in BMI in the intervention as compared to placebo (chromium = 0.3 +/- 0.8 kg/m(2) versus placebo = 0.0 +/- 0.4 kg/m(2); p = 0.07). No change was seen in BMI after 24 weeks in the intervention as compared to placebo (chromium = 0.1 +/- 0.2 kg/m(2) versus placebo = 0.0 +/- 0.5 kg/m(2); p = 0.81). Variation in central adiposity did not affect any outcome measures. CONCLUSIONS: Supplementation of 1000 microg of chromium picolinate alone, and in combination with nutritional education, did not affect weight loss in this population of overweight adults. Response to chromium did not vary with central adiposity.

Impact of home-based, supervised exercise on congestive heart failure.

AIMS: Comparison of supervised home-based exercise program as adjunctive therapy, with comprehensive disease management alone, on symptoms and quality of life in congestive heart failure patients. METHODS: 8 women and 11 men were enrolled in a randomized trial. The mean subject age was 69 (±4.44) in the controls and 70 (±4.05) in the intervention group. Baseline and 3, 6, and 12-month evaluations consisted of the Chronic Heart Failure Questionnaire (CHFQ), measuring perceived functional capacity (perceived symptoms of dyspnea, fatigue, and emotional function) and the Yale Physical Activity Survey (YPAS). A stress test was given at baseline and 12 months. RESULTS AND CONCLUSIONS: The home-based exercise intervention caused a significant change in perceived fatigue between study groups (p=0.015), after 6 months of study participation, with the control group feeling less fatigued than the intervention group. After 12 months of participation, there were no significant differences in perceived functional capacity. Home-based exercise was well tolerated and favorably evaluated. This pilot study demonstrates the feasibility of studying home-based exercise in patients with moderate congestive heart failure. Larger and longer studies will be required to determine treatment effects.

Partners reducing effects of diabetes (PREDICT): a diabetes prevention physical activity and dietary intervention through African-American churches.

Type 2 diabetes is epidemic in the United States with greater incidence rates in African-American communities. Lifestyle interventions during the phase of insulin resistance mitigate cardiovascular risk and prevent diabetes. The primary aim of this study is to test the impact of a Community Health Advisor (CHA)-based diabetes prevention controlled intervention in urban African-American communities. In this controlled trial, church congregants in New Haven, CT, receiving a 1-year CHA-led diabetes prevention intervention were compared with church congregants in Bridgeport, CT, who did not receive an intervention. Outcome measures included physical activity, dietary pattern, anthropometric measure, social support, diabetes knowledge, nutrition and exercise self-efficacy. The results indicate that at the end of the 1-year intervention period, there were no significant differences observed between intervention and control groups. Possible explanations for the lack of change include difficulty in engaging the CHAs, variability in the CHA-led interventions, baseline discrepancies between the two sites which could not be fully controlled and loss to follow-up. The results indicate important obstacles which impeded the successful implementation of this intervention and lessons learned for future interventions.

Effects of walnut consumption on endothelial function in type 2 diabetic subjects: a randomized controlled crossover trial.

OBJECTIVE: To determine the effects of daily walnut consumption on endothelial function, cardiovascular biomarkers, and anthropometric measures in type 2 diabetic individuals. RESEARCH DESIGN AND METHODS: This study was a randomized, controlled, single-blind, crossover trial. Twenty-four participants with type 2 diabetes (mean age 58 years; 14 women and 10 men) were randomly assigned to one of the two possible sequence permutations to receive an ad libitum diet enriched with 56 g (366 kcal) walnuts/day and an ad libitum diet without walnuts for 8 weeks. Subjects underwent endothelial function testing (measured as flow-mediated dilatation [FMD]) and assessment of cardiovascular biomarkers before and after each 8-week treatment phase. The primary outcome measure was the change in FMD after 8 weeks. Secondary outcome measures included changes in plasma lipids, A1C, fasting glucose, insulin sensitivity, and anthropometric measures. RESULTS: Endothelial function significantly improved after consumption of a walnut-enriched ad libitum diet compared with that after consumption of an ad libitum diet without walnuts (2.2 +/- 1.7 vs. 1.2 +/- 1.6%; P = 0.04). The walnut-enriched diet increased fasting serum glucose and lowered serum total cholesterol and LDL cholesterol from baseline (10.0 +/- 20.5 mg/dl, P = 0.04; -9.7 +/- 14.5 mg/dl, P < 0.01; and -7.7 +/- 10 mg/dl, P < 0.01, respectively), although these changes were not significant compared with those for an ad libitum diet without walnuts. There were no significant changes in anthropometric measures, plasma A1C, and insulin sensitivity. CONCLUSIONS: A walnut-enriched ad libitum diet improves endothelium-dependent vasodilatation in type 2 diabetic individuals, suggesting a potential reduction in overall cardiac risk.

Intravenous micronutrient therapy (Myers' Cocktail) for fibromyalgia: a placebo-controlled pilot study.

OBJECTIVES: Intravenous micronutrient therapy (IVMT), and specifically the Myers' Cocktail, is a popular approach for treating fibromyalgia syndrome (FMS) among complementary and alternative medicine practitioners, but its efficacy is uncertain. This trial assessed the feasibility, safety, and provided insights into the efficacy of this therapy. DESIGN: This was a randomized, double-blind, placebo-controlled pilot study. LOCATIONS: The study locations were an academic research center, teaching hospital, and affiliated Integrative Medicine Center in Derby, CT. SUBJECTS: The subjects were 34 adults with American College of Rheumatology (ACR)-defined FMS. INTERVENTION: Subjects were randomly assigned either to treatment (weekly infusions of IVMT) or to placebo (weekly infusions of lactated Ringer's solution) for 8 weeks. OUTCOME MEASURES: Primary outcome was change in the Tender Point Index, assessed 8 and 12 weeks after initiation. Secondary measures included a Visual Analog Scale to assess global pain, and validated measures of physical function (Fibromyalgia Impact Questionnaire), mood (Beck Depression Index), and quality of life (Health Status Questionnaire 2.0). RESULTS: Clinically significant improvements were noted (of a magnitude similar to other effective interventions). However, in part because of the high placebo response and the small sample size, no statistically significant differences were seen between groups, in any outcome measure, at 8 and 16 weeks. Statistically significant within-group differences were seen in both the intervention and placebo groups, demonstrating a treatment effect for both IVMT and placebo. At 8 weeks, the IVMT group experienced significantly improved tender points, pain, depression, and quality of life directly following treatment (all p < or = 0.02), while the placebo group experienced significantly improved tender points only (p < or = 0.05). The treatment effects of IVMT persisted at 4 weeks postintervention for tender points, pain, and quality of life, while placebo effects persisted only for tender points. A single minor adverse event was noted in one subject in the intervention group. CONCLUSIONS: This first controlled pilot study established the safety and feasibility of treating FMS with IVMT. Most subjects experienced relief as compared to baseline, but no statistically significant differences were seen between IVMT and placebo. The efficacy of IVMT for fibromyalgia, relative to placebo, is as yet uncertain.

Acute dark chocolate and cocoa ingestion and endothelial function: a randomized controlled crossover trial.

BACKGROUND: Studies suggest cardioprotective benefits of dark chocolate containing cocoa. OBJECTIVE: This study examines the acute effects of solid dark chocolate and liquid cocoa intake on endothelial function and blood pressure in overweight adults. DESIGN: Randomized, placebo-controlled, single-blind crossover trial of 45 healthy adults [mean age: 53 y; mean body mass index (in kg/m(2)): 30]. In phase 1, subjects were randomly assigned to consume a solid dark chocolate bar (containing 22 g cocoa powder) or a cocoa-free placebo bar (containing 0 g cocoa powder). In phase 2, subjects were randomly assigned to consume sugar-free cocoa (containing 22 g cocoa powder), sugared cocoa (containing 22 g cocoa powder), or a placebo (containing 0 g cocoa powder). RESULTS: Solid dark chocolate and liquid cocoa ingestion improved endothelial function (measured as flow-mediated dilatation) compared with placebo (dark chocolate: 4.3 +/- 3.4% compared with -1.8 +/- 3.3%; P < 0.001; sugar-free and sugared cocoa: 5.7 +/- 2.6% and 2.0 +/- 1.8% compared with -1.5 +/- 2.8%; P < 0.001). Blood pressure decreased after the ingestion of dark chocolate and sugar-free cocoa compared with placebo (dark chocolate: systolic, -3.2 +/- 5.8 mm Hg compared with 2.7 +/- 6.6 mm Hg; P < 0.001; and diastolic, -1.4 +/- 3.9 mm Hg compared with 2.7 +/- 6.4 mm Hg; P = 0.01; sugar-free cocoa: systolic, -2.1 +/- 7.0 mm Hg compared with 3.2 +/- 5.6 mm Hg; P < 0.001; and diastolic: -1.2 +/- 8.7 mm Hg compared with 2.8 +/- 5.6 mm Hg; P = 0.014). Endothelial function improved significantly more with sugar-free than with regular cocoa (5.7 +/- 2.6% compared with 2.0 +/- 1.8%; P < 0.001). CONCLUSIONS: The acute ingestion of both solid dark chocolate and liquid cocoa improved endothelial function and lowered blood pressure in overweight adults. Sugar content may attenuate these effects, and sugar-free preparations may augment them.

Effect of soy isoflavone protein and soy lecithin on endothelial function in healthy postmenopausal women.

OBJECTIVE: To assess the effects of soy isoflavone protein concentrate and soy lecithin on endothelial function, measured as flow-mediated dilation (FMD) of the brachial artery in healthy postmenopausal women. DESIGN: This was a randomized, double-blind, placebo-controlled crossover trial with 25 participants (mean age, 61 years; body mass index, 25.46 kg/m2). The women underwent endothelial function testing at baseline and after 4 weeks of randomly assigned treatment with intervening 4-week washout periods. Treatment assignments included soy isoflavone protein (25 g/day) and soy lecithin (20 g/day), soy isoflavone protein (25 g/day) and placebo lecithin, placebo protein and soy lecithin (20 g/day), and double placebo. FMD and serum lipid levels were assessed at baseline and the end of each 4-week treatment phase. RESULTS: Twenty-two women completed the trial. No statistically significant (P > 0.05) difference was seen in FMD between treatment groups. A trend was suggested with FMD highest after treatment with soy protein plus lecithin (7.50 +/- 9.85), followed by soy protein (5.51 +/- 10.11), soy lecithin (5.35 +/- 6.13), and lowest after placebo (4.53 +/- 7.84). Soy isoflavone protein and soy lecithin significantly increased the high-density lipoprotein/low-density lipoprotein ratio (soy isoflavone protein plus soy lecithin, 0.64 +/- 0.19, P < 0.0001; soy isoflavone protein plus placebo lecithin, 0.58 +/- 0.17, P = 0.0058; placebo protein plus soy lecithin, 0.65 +/- 0.18, P < 0.0001) relative to the baseline value (0.49 +/- 0.15). CONCLUSIONS: In this sample of healthy postmenopausal women, soy isoflavone protein and soy lecithin significantly improved the lipid profile. A favorable influence on endothelial function could not be confirmed.

Massage therapy for osteoarthritis of the knee: a randomized controlled trial.

BACKGROUND: Massage therapy is an attractive treatment option for osteoarthritis (OA), but its efficacy is uncertain. We conducted a randomized, controlled trial of massage therapy for OA of the knee. METHODS: Sixty-eight adults with radiographically confirmed OA of the knee were assigned either to treatment (twice-weekly sessions of standard Swedish massage in weeks 1-4 and once-weekly sessions in weeks 5-8) or to control (delayed intervention). Primary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and functional scores and the visual analog scale of pain assessment. The sample provided 80% statistical power to detect a 20-point difference between groups in the change from baseline on the WOMAC and visual analog scale, with a 2-tailed alpha of .05. RESULTS: The group receiving massage therapy demonstrated significant improvements in the mean (SD) WOMAC global scores (-17.44 [23.61] mm; P < .001), pain (-18.36 [23.28]; P < .001), stiffness (-16.63 [28.82] mm; P < .001), and physical function domains (-17.27 [24.36] mm; P < .001) and in the visual analog scale of pain assessment (-19.38 [28.16] mm; P < .001), range of motion in degrees (3.57 [13.61]; P = .03), and time to walk 50 ft (15 m) in seconds (-1.77 [2.73]; P < .01). Findings were unchanged in multivariable models controlling for demographic factors. CONCLUSIONS: Massage therapy seems to be efficacious in the treatment of OA of the knee. Further study of cost effectiveness and duration of treatment effect is clearly warranted. .

Repeated serum lipid measurements during the peri-hospitalization period.

The early treatment of hyperlipidemia in hospitalized patients confers potential benefit, yet total cholesterol is known to vary with acute illness, often delaying treatment decisions. A prospective study was conducted of 61 patients (mean age 57 years; 49% women) admitted to an acute care community hospital with various diagnoses with random nonfasting lipid profile measurements at admission, followed by second fasting lipid profile measurements on day 3 of hospitalization or upon discharge (whichever occurred first), and final fasting lipid profile measurements 4 weeks after discharge. All individual values of the lipid profile decreases at discharge, whereas the ratios of total cholesterol to high-density lipoprotein (HDL) and of low-density lipoprotein (LDL) to HDL did not change significantly. The 95% confidence interval around the total cholesterol/HDL ratio for each patient was within the same National Cholesterol Education Program Adult Treatment Panel III treatment recommendation category 42.6% of the time, whereas corresponding intervals for total cholesterol and LDL were within a single treatment category only 6.6% of the time. The total cholesterol/HDL ratio was significantly more consistent with regard to treatment implications than LDL or total cholesterol (p <0.0001). In conclusion, serum lipid values vary significantly during and after a hospital stay, whereas the ratio of total cholesterol to HDL remains relatively stable. This ratio may therefore serve as a more reliable basis for early treatment decisions in dyslipidemia.

Homeopathy for attention-deficit/hyperactivity disorder: a pilot randomized-controlled trial.

OBJECTIVES: The aim of this study was to carry out a preliminary trial evaluating the effectiveness of homeopathy in the treatment of attention-deficit/hyperactivity disorder (ADHD). DESIGN: This work was a randomized, double-blind, placebo-controlled trial. SETTINGS/LOCATION: This study was conducted in a private homeopathic clinic in the Seattle metropolitan area. SUBJECTS: Subjects included children 6-12 years of age meeting Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria for ADHD. INTERVENTIONS: Forty-three subjects were randomized to receive a homeopathic consultation and either an individualized homeopathic remedy or placebo. Patients were seen by homeopathic physicians every 6 weeks for 18 weeks. OUTCOME MEASURES: Outcome measures included the Conner's Global Index-Parent, Conner's Global Index- Teacher, Conner's Parent Rating Scale-Brief, Continuous Performance Test, and the Clinical Global Impression Scale. RESULTS: There were no statistically significant differences between homeopathic remedy and placebo groups on the primary or secondary outcome variables. However, there were statistically and clinically significant improvements in both groups on many of the outcome measures. CONCLUSIONS: This pilot study provides no evidence to support a therapeutic effect of individually selected homeopathic remedies in children with ADHD. A therapeutic effect of the homeopathic encounter is suggested and warrants further evaluation. Future studies should be carried out over a longer period of time and should include a control group that does not receive the homeopathic consultation. Comparison to conventional stimulant medication for ADHD also should be considered.

A randomized controlled trial of meditation and massage effects on quality of life in people with late-stage disease: a pilot study.

CONTEXT: Certain meditation practices may effectively address spiritual needs near end-of-life, an often overlooked aspect of quality of life (QOL). Among people subject to physical isolation, meditation benefits may be blunted unless physical contact is also addressed. OBJECTIVE: To evaluate independent and interactive effects of Metta meditation and massage on QOL in people with acquired immunodeficiency syndrome (AIDS). DESIGN: Randomized controlled blinded factorial pilot trial conducted from November 2001 to September 2003. SETTING: An AIDS-dedicated skilled nursing facility in New Haven, Connecticut. PARTICIPANTS: Fifty-eight residents (43% women) with late stage disease (AIDS or comorbidity). INTERVENTIONS: Residents were randomized to 1 month of meditation, massage, combined meditation and massage, or standard care. The meditation group received instruction, then self-administered a meditation audiocassette daily. A certified massage therapist provided the massage intervention 30 minutes per day 5 days per week. OUTCOME MEASURE: Changes on Missoula-Vitas QOL Index overall and transcendent (spiritual) scores at 8 weeks. RESULTS: The combined group showed improvement in overall (p = 0.005) and transcendent (p = 0.01) scores from baseline to 8 weeks, a change significantly greater (p < 0.05) than the meditation, massage, and control groups. CONCLUSIONS: The combination of meditation and massage has a significantly favorable influence on overall and spiritual QOL in late-stage disease relative to standard care, or either intervention component alone.