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Effects of nutritional supplementation for HIV patients starting antiretroviral treatment: randomised controlled trial in Ethiopia.
Olsen, MF, Abdissa, A, Kæstel, P, Tesfaye, M, Yilma, D, Girma, T, Wells, JC, Ritz, C, Mølgaard, C, Michaelsen, KF, et al
BMJ (Clinical research ed.). 2014;:g3187
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Abstract
OBJECTIVES To determine the effects of lipid based nutritional supplements with either whey or soy protein in patients with HIV during the first three months of antiretroviral treatment (ART) and to explore effects of timing by comparing supplementation at the start of ART and after three months delay. DESIGN Randomised controlled trial. SETTING Three public ART facilities in Jimma, Oromia region, Ethiopia. PARTICIPANTS Adults with HIV eligible for ART with body mass index (BMI) >16. INTERVENTION Daily supplementation with 200 g (4600 kJ) of supplement containing whey or soy during either the first three or the subsequent three months of ART. OUTCOME MEASURES Primary: lean body mass assessed with deuterium dilution, grip strength measured with dynamometers, and physical activity measured with accelerometer and heart rate monitors. Secondary: viral load and CD4 counts. Auxiliary: weight and CD3 and CD8 counts. RESULTS Of 318 patients enrolled, 210 (66%) were women, mean age was 33 (SD 9), and mean BMI was 19.5 (SD 2.4). At three months, participants receiving the supplements containing whey or soy had increased their lean body mass by 0.85 kg (95% confidence interval 0.16 kg to 1.53 kg) and 0.97 kg (0.29 kg to 1.64 kg), respectively, more than controls. This was accompanied by an increased gain of grip strength of 0.68 kg (-0.11 kg to 1.46 kg) for the whey supplement group and 0.93 kg (0.16 kg to 1.70 kg) for the soy supplement group. There were no effects on physical activity. Total weight gain increased by 2.05 kg (1.12 kg to 2.99 kg) and 2.06 kg (1.14 kg to 2.97 kg) for the whey and soy groups, respectively. In addition, in the whey supplement group overall CD3 counts improved by 150 cells/µL (24 to 275 cells/µL), of which 112 cells/µL (15 to 209 cells/µL) were CD8 and 25 cells/µL (-2 to 53 cells/µL) were CD4. Effects of the soy containing supplement on immune recovery were not significant. The effects of the two supplements, however, were not significantly different in direct comparison. Exploratory analysis showed that relatively more lean body mass was gained by patients with undetectable viral load at three months. Patients receiving delayed supplementation had higher weight gain but lower gains in functional outcomes. CONCLUSIONS Lipid based nutritional supplements improved gain of weight, lean body mass, and grip strength in patients with HIV starting ART. Supplements containing whey were associated with improved immune recovery. Trial registration Controlled-trials.com ISRCTN32453477.
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Randomized trial to assess the impact of venlafaxine and soy protein on hot flashes and quality of life in men with prostate cancer.
Vitolins, MZ, Griffin, L, Tomlinson, WV, Vuky, J, Adams, PT, Moose, D, Frizzell, B, Lesser, GJ, Naughton, M, Radford, JE, et al
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2013;(32):4092-8
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Abstract
PURPOSE Hot flashes occur in approximately 80% of androgen-deprived men. Few intervention studies have been conducted to relieve hot flashes in men. PATIENTS AND METHODS Eligible androgen-deprived men were randomly assigned to one of four daily regimens (2 × 2 factorial design) for 12 weeks: milk protein powder and placebo pill, venlafaxine and milk protein powder, soy protein powder and placebo pill, or venlafaxine and soy protein powder. The primary end point was hot flash symptom severity score (HFSSS), defined as number of hot flashes times severity. The secondary end point was quality of life (QoL), assessed by using the Functional Assessment of Cancer Therapy-Prostate. RESULTS In all, 120 men age 46 to 91 years participated. Most were white (78%) and overweight or obese (83%). Toxicity was minimal. Neither venlafaxine nor soy protein alone or in combination had a significant effect on HFSSS. Soy protein, but not venlafaxine, improved measures of QoL. CONCLUSION In androgen-deprived men, neither venlafaxine nor soy proved effective in reducing hot flashes. Interventions that appear effective for decreasing hot flashes in women may not always turn out to be effective in men.
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Effect of soy protein isolate supplementation on biochemical recurrence of prostate cancer after radical prostatectomy: a randomized trial.
Bosland, MC, Kato, I, Zeleniuch-Jacquotte, A, Schmoll, J, Enk Rueter, E, Melamed, J, Kong, MX, Macias, V, Kajdacsy-Balla, A, Lumey, LH, et al
JAMA. 2013;(2):170-8
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IMPORTANCE Soy consumption has been suggested to reduce risk or recurrence of prostate cancer, but this has not been tested in a randomized trial with prostate cancer as the end point. OBJECTIVE To determine whether daily consumption of a soy protein isolate supplement for 2 years reduces the rate of biochemical recurrence of prostate cancer after radical prostatectomy or delays such recurrence. DESIGN, SETTING, AND PARTICIPANTS Randomized, double-blind trial conducted from July 1997 to May 2010 at 7 US centers comparing daily consumption of a soy protein supplement vs placebo in 177 men at high risk of recurrence after radical prostatectomy for prostate cancer. Supplement intervention was started within 4 months after surgery and continued for up to 2 years, with prostate-specific antigen (PSA) measurements made at 2-month intervals in the first year and every 3 months thereafter. INTERVENTION Participants were randomized to receive a daily serving of a beverage powder containing 20 g of protein in the form of either soy protein isolate (n=87) or, as placebo, calcium caseinate (n=90). MAIN OUTCOMES AND MEASURES Biochemical recurrence rate of prostate cancer (defined as development of a PSA level of ≥0.07 ng/mL) over the first 2 years following randomization and time to recurrence. RESULTS The trial was stopped early for lack of treatment effects at a planned interim analysis with 81 evaluable participants in the intervention group and 78 in the placebo group. Overall, 28.3% of participants developed biochemical recurrence within 2 years of entering the trial (close to the a priori predicted recurrence rate of 30%). Among these, 22 (27.2%) occurred in the intervention group and 23 (29.5%) in the placebo group. The resulting hazard ratio for active treatment was 0.96 (95% CI, 0.53-1.72; log-rank P = .89). Adherence was greater than 90% and there were no apparent adverse events related to supplementation. CONCLUSION AND RELEVANCE Daily consumption of a beverage powder supplement containing soy protein isolate for 2 years following radical prostatectomy did not reduce biochemical recurrence of prostate cancer in men at high risk of PSA failure. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00765479.
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Effect of soybean protein on novel cardiovascular disease risk factors: a randomized controlled trial.
Rebholz, CM, Reynolds, K, Wofford, MR, Chen, J, Kelly, TN, Mei, H, Whelton, PK, He, J
European journal of clinical nutrition. 2013;(1):58-63
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BACKGROUND/OBJECTIVES Cardiovascular disease (CVD) is the leading cause of death in the United States and the world. Clinical trials have suggested that soybean protein lowers lipids and blood pressure. The effect of soybean protein on novel CVD risk factors has not been well studied. The objective of this study was to examine the effect of soybean protein on biomarkers of inflammation, endothelial dysfunction and adipocytokines. SUBJECTS/METHODS The effect of 8 weeks of 40 g of soybean protein supplement (89.3 mg isoflavones), 40 g of milk protein supplement and 40 g of complex carbohydrate placebo was examined in a randomized, placebo-controlled, double-blind, three-phase crossover trial among adults in New Orleans, Louisiana and Jackson, Mississippi. Plasma levels of inflammation biomarkers (C-reactive protein, interleukin-6, tumor necrosis factor-α), endothelial dysfunction biomarkers (E-selectin, intercellular adhesion molecule-1, vascular cell adhesion molecule-1, thrombomodulin) and adipocytokines (high-molecular weight adiponectin, leptin, resistin) were measured at baseline and at the end of each intervention using immunoturbidimetric and enzyme-linked immunosorbent assay techniques. RESULTS Soy protein supplementation resulted in a significant mean net change (95% confidence interval) in plasma E-selectin of -3.93 ng/ml (-7.05 to -0.81 ng/ml; P=0.014) compared with milk protein, and in plasma leptin of -2089.8 pg/ml (-3689.3 to -490.3 pg/ml; P=0.011) compared with carbohydrate. There were no significant changes in any other risk factors. CONCLUSIONS Soy protein supplementation may reduce levels of E-selectin and leptin. Further research is warranted to investigate the mechanisms through which protein may confer protective effects on novel CVD risk factors.
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Effect of soybean protein on blood pressure: a randomized, controlled trial.
He, J, Gu, D, Wu, X, Chen, J, Duan, X, Chen, J, Whelton, PK
Annals of internal medicine. 2005;(1):1-9
Abstract
BACKGROUND Epidemiologic studies suggest that vegetable protein intake is inversely related to blood pressure. OBJECTIVE To examine the effect of soybean protein supplementation on blood pressure in persons with prehypertension or stage 1 hypertension. DESIGN Randomized, double-blind, controlled trial. SETTING Three communities in the People's Republic of China. PATIENTS 302 participants 35 to 64 years of age with an initial untreated systolic blood pressure of 130 to 159 mm Hg, diastolic blood pressure of 80 to 99 mm Hg, or both. INTERVENTION Study participants were randomly assigned to receive 40 g of isolated soybean protein supplements per day or complex carbohydrate control for 12 weeks; 91.4% completed the intervention. MEASUREMENTS Blood pressure measurements were obtained by using random-zero sphygmomanometers at baseline and at 6 and 12 weeks. RESULTS At baseline, the mean systolic and diastolic blood pressures were 135.0 mm Hg (SD 10.9) and 84.7 mm Hg (SD 6.9), respectively. Compared with the control group, the net changes in systolic blood pressure and diastolic blood pressure were -4.31 mm Hg (95% CI, -2.11 to -6.51 mm Hg; P < 0.001) and -2.76 mm Hg (CI, -1.35 to -4.16 mm Hg; P < 0.001), respectively, after the 12-week intervention. The net changes in systolic and diastolic blood pressure reductions were -7.88 mm Hg (CI, -4.66 to -11.1 mm Hg) and -5.27 mm Hg (CI, -3.05 to -7.49 mm Hg), respectively, in persons with hypertension and -2.34 mm Hg (CI, 0.48 to -5.17 mm Hg) and -1.28 mm Hg (CI, 0.52 to -3.07 mm Hg), respectively, in those without hypertension. LIMITATIONS This trial did not examine whether the blood pressure reduction was due to protein or isoflavones in soybean. CONCLUSIONS Soybean protein supplementation resulted in a reduction in systolic and diastolic blood pressure. These findings suggest that increased intake of soybean protein may play an important role in preventing and treating hypertension.
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Plasma lipoproteins in soy-treated postmenopausal women: a double-blind, placebo-controlled trial.
Vigna, GB, Pansini, F, Bonaccorsi, G, Albertazzi, P, Donegà, P, Zanotti, L, De Aloysio, D, Mollica, G, Fellin, R
Nutrition, metabolism, and cardiovascular diseases : NMCD. 2000;(6):315-22
Abstract
BACKGROUND AND AIM Postmenopausal modification of the lipid profile plays a major role in the risk of ischemic heart disease. Lifestyle counseling and estrogen replacement therapy have all been proposed as first-line measures, but there is no agreement on the best way to treat climacteric dyslipidemia. Soybean-based diet seems particularly attractive in this context, given its cholesterol lowering potential, its hypothetical anticancerous effects and possible modification of climacteric symptoms. METHODS AND RESULTS We evaluated the effect of 60 g isolated soy protein (ISP) daily on the lipid profile of 104 postmenopausal women (53.3 +/- 3.3 years) in a double-blind, parallel, placebo-controlled (caseinate) trial, as part of a broader assessment of the effect of ISP on climacteric symptomatology. Serum total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, apo A-I, apo B and lipoprotein (a) were determined before and after a 12-week diet modification. Seventy-seven women completed the trial. Both soy and placebo determined a significant reduction in total cholesterol (-0.42 +/- 0.79 and -0.40 +/- 0.57 mmol/L) and LDL-cholesterol (-0.35 +/- 0.72 and -0.31 +/- 0.54 mmol/L), but only soy had a significant lowering effect on apo B and the LDL-cholesterol/HDL-cholesterol ratio (-6% and -8% from baseline respectively); lipoprotein (a) plasma levels were not significantly changed by either treatment. Forty-four women were dyslipidemic at baseline; those with increased LDL concentrations showed a somewhat greater improvement in their lipoprotein profile (LDL-cholesterol and apo B reduction) with soy rather than placebo. No further information emerged when the subjects were divided into three apo E phenotypes. CONCLUSIONS We conclude that diet supplementation with 60 g ISP is slightly better than caseinate in favorably modifying the lipoprotein metabolism of postmenopausal women; this effect is more evident in hypercholesterolemic subjects.