-
1.
Comprehensive lifestyle intervention vs soy protein-based meal regimen in non-alcoholic steatohepatitis.
Deibert, P, Lazaro, A, Schaffner, D, Berg, A, Koenig, D, Kreisel, W, Baumstark, MW, Steinmann, D, Buechert, M, Lange, T
World journal of gastroenterology. 2019;(9):1116-1131
Abstract
BACKGROUND Non-alcoholic steatohepatitis (NASH) has become one of the leading causes of liver disease in the western world. In obese patients weight reduction is recommended. Up to now there are no specific guidelines for weight loss in order to reduce hepatic fat content. AIM: To investigate the effects of a 24-wk guided lifestyle intervention program compared to a meal replacement regimen based on soy protein. METHODS Twenty-six subjects with NASH participated in a randomized single-center study. They were randomly assigned to either meal replacement group (MR-G) with soy-yogurt-honey preparation or to guided lifestyle change group (LC-G) with endurance activity and nutrition counselling. Serum alanine transaminase (ALT), aspartate transaminase (AST), lipid parameters, and adipokines were measured. Liver fat content and lipid composition were determined by magnetic resonance imaging and magnetic resonance spectroscopy. Body fat mass and lean body mass were assessed using Bod Pod® device. Pre- and post-intervention monitoring of parameters was performed. Statistical analyses were conducted with SPSS software, results were expressed as median (interquartile range). RESULTS Twenty-two subjects (MR-G, n = 11 and LC-G, n = 11) completed the study (9 women, 13 men; age 52.1 (15.0) years, body mass index (BMI) 32.3 (3.3) kg/m²). In both groups a significant weight loss was achieved (MR-G: -6.4 (3.6) kg, P < 0.01; LC-G: -9.1 (10.4) kg, P < 0.01). BMI dropped in both groups (MR-G: -2.3 (1.5) kg/m2, P = 0.003; LC-G: -3.0 (3.4) kg/m2, P = 0.006). Internal fat and hepatic lipid content were markedly reduced in both groups in comparable amount. There was a strong correlation between reduction in liver fat and decrease in ALT. Likewise, both groups showed an improvement in glycemic control and lipid profile. Changes in adipokines, particularly in adiponectin and leptin were closely related to intrahepatic lipid changes. CONCLUSION Comprehensive lifestyle intervention and meal replacement regimen have comparable effects on body and liver fat, as well as decrease in markers of hepatic inflammation among NASH patients.
-
2.
Glycemic effects following the consumption of mixed soy protein isolate and alginate beverages in healthy adults.
Huang, Z, Wang, Y, Shafer, R, Winn, NC, Kanaley, JA, Vardhanabhuti, B
Food & function. 2019;(3):1718-1725
Abstract
This study examined whether the consumption of beverages containing mixed soy protein isolate (SPI) and fiber, alginate (ALG), would affect postprandial glucose and insulin responses or appetite in healthy adults. Following an overnight fast, twelve healthy subjects were asked to consume six standardized breakfast beverages in a randomized order: a 122 kcal sugar beverage (CONT), a 122 kcal sugar beverage with ALG, a 172 kcal sugar beverage with SPI at pH 7 (SPI-7) or 6 (SPI-6), and a 172 kcal sugar beverage with mixed SPI and alginate at pH 7 (SPI + ALG-7) or 6 (SPI + ALG-6). Subjects consumed one of the beverages at time 0. Blood samples were drawn at -15, 0, 15, 30, 45, 60, 90 and 120 min and questionnaires were completed immediately following the blood drawing at each time point. The results showed that, compared to CONT, the consumption of SPI-7, SPI-6, SPI + ALG-7 and SPI + ALG-6 significantly lowered (P < 0.05) the peak plasma glucose concentration (33.4%, 36.3%, 53.2%, and 58.5%, respectively), 120 min incremental area under the curve (AUC), and peak insulin concentration. SPI + ALG-6 and SPI + ALG-7 exhibited a significant reduction in the peak glucose concentration compared to SPI without alginate (P < 0.05). No significant effect on appetite was found in any conditions. Electrostatic interactions between the protein and alginate during digestion and formation of intragastric gel could play an important role in influencing the postprandial glucose response. This study indicates that the consumption of mixed SPI and ALG beverages was the most effective in attenuating the postprandial glycemic excursion in healthy adult subjects.
-
3.
A Meta-Analysis of 46 Studies Identified by the FDA Demonstrates that Soy Protein Decreases Circulating LDL and Total Cholesterol Concentrations in Adults.
Blanco Mejia, S, Messina, M, Li, SS, Viguiliouk, E, Chiavaroli, L, Khan, TA, Srichaikul, K, Mirrahimi, A, Sievenpiper, JL, Kris-Etherton, P, et al
The Journal of nutrition. 2019;(6):968-981
-
-
Free full text
-
Abstract
BACKGROUND Certain plant foods (nuts and soy protein) and food components (viscous fibers and plant sterols) have been permitted by the FDA to carry a heart health claim based on their cholesterol-lowering ability. The FDA is currently considering revoking the heart health claim for soy protein due to a perceived lack of consistent LDL cholesterol reduction in randomized controlled trials. OBJECTIVE We performed a meta-analysis of the 46 controlled trials on which the FDA will base its decision to revoke the heart health claim for soy protein. METHODS We included the 46 trials on adult men and women, with baseline circulating LDL cholesterol concentrations ranging from 110 to 201 mg/dL, as identified by the FDA, that studied the effects of soy protein on LDL cholesterol and total cholesterol (TC) compared with non-soy protein. Two independent reviewers extracted relevant data. Data were pooled by the generic inverse variance method with a random effects model and expressed as mean differences with 95% CI. Heterogeneity was assessed and quantified. RESULTS Of the 46 trials identified by the FDA, 43 provided data for meta-analyses. Of these, 41 provided data for LDL cholesterol, and all 43 provided data for TC. Soy protein at a median dose of 25 g/d during a median follow-up of 6 wk decreased LDL cholesterol by 4.76 mg/dL (95% CI: -6.71, -2.80 mg/dL, P < 0.0001; I2 = 55%, P < 0.0001) and decreased TC by 6.41 mg/dL (95% CI: -9.30, -3.52 mg/dL, P < 0.0001; I2 = 74%, P < 0.0001) compared with non-soy protein controls. There was no dose-response effect or evidence of publication bias for either outcome. Inspection of the individual trial estimates indicated most trials (∼75%) showed a reduction in LDL cholesterol (range: -0.77 to -58.60 mg/dL), although only a minority of these were individually statistically significant. CONCLUSIONS Soy protein significantly reduced LDL cholesterol by approximately 3-4% in adults. Our data support the advice given to the general public internationally to increase plant protein intake. This trial was registered at clinicaltrials.gov as NCT03468127.
-
4.
Lunasin does not slow ALS progression: results of an open-label, single-center, hybrid-virtual 12-month trial.
Bedlack, RS, Wicks, P, Vaughan, T, Opie, A, Blum, R, Dios, A, Sadri-Vakili, G
Amyotrophic lateral sclerosis & frontotemporal degeneration. 2019;(3-4):285-293
Abstract
Objective: Lunasin, a soy peptide that reportedly alters histone acetylation in vitro, was associated with a single ALS reversal in the media. Following an ALSUntangled report, we sought to determine whether Lunasin altered histone acetylation and improved progression in people with ALS, and whether patient-centric trial design features might improve enrollment and retention. Methods: This single-center, year-long trial (NCT02709330) featured broad inclusion criteria, historical controls, primarily virtual data collection, and real-time results. Participants measured their own ALSFRS-R score, weight and perceived efficacy, and recorded these monthly on PatientsLikeMe. Blood tests at screening and month 1 assessed alterations in histone H3 and H4 acetylation. The protocol was published online, empowering patients outside the study to self-experiment. Results: Fifty participants enrolled in 5.5 months. Although this population had more advanced disease compared to other trials, retention and adherence were very high. There was no significant effect of Lunasin treatment on histone acetylation or disease progression. A cohort following our protocol outside the trial reported similar side effects and perceived effectiveness; however, their compliance with data entry was markedly lower. Conclusions: While Lunasin's lack of efficacy is disappointing, our novel trial design had the highest ALS trial enrollment rate ever recorded, with excellent retention and adherence. Low data density from patients who are self-experimenting outside a formal protocol casts doubt on the possibility of gathering useful information from unsupervised expanded access programs or "right to try" initiatives.
-
5.
Soy, Soy Isoflavones, and Protein Intake in Relation to Mortality from All Causes, Cancers, and Cardiovascular Diseases: A Systematic Review and Dose-Response Meta-Analysis of Prospective Cohort Studies.
Nachvak, SM, Moradi, S, Anjom-Shoae, J, Rahmani, J, Nasiri, M, Maleki, V, Sadeghi, O
Journal of the Academy of Nutrition and Dietetics. 2019;(9):1483-1500.e17
Abstract
OBJECTIVE We conducted a systematic review and dose-response meta-analysis of prospective studies to summarize findings on the associations between intakes of soy, soy isoflavones, and soy protein and risk of mortality from all causes, cancers, and cardiovascular diseases. METHODS Online databases were systematically searched to identify relevant articles published earlier than May 2018. We applied restricted cubic splines using random-effects analysis to assess dose-response associations. Between-study heterogeneity was assessed by I2 value and Cochrane Q test. Potential publication bias was assessed by visual inspection of funnel plots and Begg regression test. RESULTS In total, 23 prospective studies with an overall sample size of 330,826 participants were included in the current systematic review and the meta-analysis. Soy/soy products consumption was inversely associated with deaths from cancers (pooled relative risk 0.88, 95% CI 0.79 to 0.99; P=0.03; I2=47.1%, 95% CI 0.0% to 75.4%) and cardiovascular diseases (pooled effect size: 0.85, 95% CI 0.72 to 0.99; P=0.04; I2=50.0%, 95% CI 0.0% to 77.6%). Such significant associations were also observed for all-cause mortality in some subgroups of the included studies, particularly those with higher quality. In addition, higher intake of soy was associated with decreased risk of mortality from gastric, colorectal, and lung cancers as well as ischemic cardiovascular diseases. Participants in the highest category of dietary soy isoflavones intake had a 10% lower risk of all-cause mortality compared with those in the lowest category. We also found that a 10-mg/day increase in intake of soy isoflavones was associated with 7% and 9% decreased risk of mortality from all cancers and also breast cancer respectively. Furthermore, a 12% reduction in breast cancer death was indicated for each 5-g/day increase in consumption of soy protein. However, intake of soy protein was not significantly associated with all-cause and cardiovascular diseases mortality. CONCLUSIONS Soy and its isoflavones may favorably influence risk of mortality. In addition, soy protein intake was associated with a decreased risk in the mortality of breast cancer. Our findings may support the current recommendations to increase intake of soy for greater longevity.
-
6.
Cumulative Meta-Analysis of the Soy Effect Over Time.
Jenkins, DJA, Blanco Mejia, S, Chiavaroli, L, Viguiliouk, E, Li, SS, Kendall, CWC, Vuksan, V, Sievenpiper, JL
Journal of the American Heart Association. 2019;(13):e012458
Abstract
Background Soy protein foods have attracted attention as useful plant protein foods with mild cholesterol-lowering effects that are suitable for inclusion in therapeutic diets. But on the basis of the lack of consistency in significant cholesterol reduction by soy in 46 randomized controlled trials, the US Food and Drug Administration (FDA) is reassessing whether the 1999 heart health claim for soy protein should be revoked. Methods and Results We have, therefore, performed a cumulative meta-analysis on the 46 soy trials identified by the FDA to determine if at any time, since the 1999 FDA final rule that established the soy heart health claim, the soy effect on serum cholesterol lost significance. The cumulative meta-analysis for both total cholesterol and low-density lipoprotein cholesterol demonstrated preservation of the small, but significant, reductions seen both before and during the subsequent 14 years since the health claim was originally approved. For low-density lipoprotein cholesterol, the mean reduction in 1999 was -6.3 mg/dL (95% CI, -8.7 to -3.9 mg/dL; P=0.00001) and remained in the range of -4.2 to -6.7 mg/dL ( P=0.0006 to P=0.0002, respectively) in the years after 1999. At no time point did the total cholesterol or low-density lipoprotein cholesterol reductions lose significance or were the differences at individual time points in the cumulative meta-analysis significantly different from those seen in 1999 when the health claim was approved. Conclusions A cumulative meta-analysis of the data selected by the FDA indicates continued significance of total cholesterol and low-density lipoprotein cholesterol reduction after soy consumption and supports the rationale behind the original soy FDA heart health claim.
-
7.
Soy and isoflavones consumption and breast cancer survival and recurrence: a systematic review and meta-analysis.
Qiu, S, Jiang, C
European journal of nutrition. 2019;(8):3079-3090
Abstract
BACKGROUND Some studies have investigated the association between soy and isoflavones consumption and breast cancer survival, but the results are far from conclusive. Accordingly, we performed a systematic review and meta-analysis to explore this issue. METHODS We performed a comprehensive search of Web of Science, PubMed, and Embase from inception to January 2018. The summary hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using a random effects model. RESULTS A total of 12 articles were included, which reported overall survival (OS), breast cancer specific survival (BCSS), and recurrence in 5770, 2386, and 1500 cases, respectively, among 37,275 women with breast cancer. The summary HR (95% CI) for the association (highest vs. lowest) of pre-diagnosis soy and isoflavones consumption with OS and BCSS was 0.84 (0.71-0.98) and 0.89 (0.74-1.07), respectively. Stratified analyses suggested that the reduced OS was more easily detected in studies that focused on post-menopausal patients. No significant association was found between post-diagnosis soy and isoflavones consumption with OS and BCSS, with summary HRs (95% CIs) of 0.80 (0.62-1.04) and 0.83 (0.64-1.07), respectively. Pre- and post-diagnosis soy isoflavones consumption were associated with reduced risk of recurrence. CONCLUSION This study provides limited evidence that pre-diagnosis soy and isoflavones intake is associated with a small reduction in post-menopausal breast cancer OS.
-
8.
Effect of Daily Exposure to an Isolated Soy Protein Supplement on Body Composition, Energy and Macronutrient Intake, Bone Formation Markers, and Lipid Profile in Children in Colombia.
Mejía, W, Córdoba, D, Durán, P, Chacón, Y, Rosselli, D
Journal of dietary supplements. 2019;(1):1-13
Abstract
A soy protein-based supplement may optimize bone health, support physical growth, and stimulate bone formation. This study aimed to assess the effect of a daily soy protein supplement (SPS) on nutritional status, bone formation markers, lipid profile, and daily energy and macronutrient intake in children. One hundred seven participants (62 girls), ages 2 to 9, started the study and were randomly assigned to lunch fruit juice with (n = 57, intervention group) or without (n = 50, control group) addition of 45 g (230 Kcal) of a commercial SPS during 12 months; 84 children (51 girls, 33 boys) completed the study (45 and 39 intervention and control, respectively). Nutritional assessment included anthropometry and nutrient intakes; initial and final blood samples were taken; insulin-like growth factor-I (IGF-I), osteocalcin, bone specific alkaline phosphatase (BAP), insulin-like growth factor binding protein-3 (IGFBP-3), cholesterol, triglycerides, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) were analyzed. Statistically significant changes (p < .05) in body mass index and weight for age Z scores were observed between groups while changes in body composition were not. Changes in energy, total protein, and carbohydrate intakes were significantly higher in the intervention group (p < .01). Calorie intake changes were statistically significant between groups (p < .001), and BAP decreased in both groups, with values within normal ranges. Osteocalcin, IGFBP-3, and lipid profile were not different between groups. IGF-I levels and IGF/IGFBP-3 ratio increased significantly in both groups. In conclusion, changes in macronutrient and energy intake and nutritional status in the intervention group compared to control group may ensure harmonious and adequate bone health and development.
-
9.
Soy isoflavones improve cardiovascular disease risk markers in women during the early menopause.
Sathyapalan, T, Aye, M, Rigby, AS, Thatcher, NJ, Dargham, SR, Kilpatrick, ES, Atkin, SL
Nutrition, metabolism, and cardiovascular diseases : NMCD. 2018;(7):691-697
Abstract
BACKGROUND Hormone replacement therapy may be beneficial for cardiovascular disease risk (CVR) in post-menopausal women. Soy isoflavones may act as selective estrogen receptor modulators. The aim of this study was to evaluate whether soy isoflavones had an effect on CVR markers. METHODS The expected 10-year risk of cardiovascular disease and mortality were calculated as a secondary endpoint from a double blind randomised parallel study involving 200 women (mean age 55 years, Caucasian, Hull, UK, 2012) in the early menopause who were randomised to 15 g soy protein with 66 mg isoflavone (SPI) or 15 g soy protein alone (depleted of all isoflavones; SP) given as a snack bar between meals daily for 6 months. Age, diabetes, smoking, blood pressure and lipid profiles were used to calculate CVR using the Framingham CVR engine. RESULTS SPI treatment resulted in a significant reduction in the metabolic parameters and systolic blood pressure compared to SP (p < 0.01). There were no changes in fasting lipid profile and diastolic blood pressure with either treatment. At 6 months, changes in these parameters with SPI treatment were reflected in a calculated 27% (p < 0.01) reduction in 10 year coronary heart disease risk, a 37% (p < 0.01) reduction in myocardial infarction risk, a 24% (p < 0.04) reduction in cardiovascular disease and 42% (p < 0.02) reduction in cardiovascular disease death risk. CONCLUSIONS Supplementation with soy protein with isoflavones for 6 months significantly improved CVR markers and calculated CVR at 6 months during early menopause compared to soy protein without isoflavones. ISRCTN REGISTRY ISRCTN34051237.
-
10.
Development and Characterization of a Soybean Experimental Line Lacking the α' Subunit of β-Conglycinin and G1, G2, and G4 Glycinin.
Song, B, Oehrle, NW, Liu, S, Krishnan, HB
Journal of agricultural and food chemistry. 2018;(2):432-439
Abstract
A soybean experimental line (BSH-3) devoid of a subset of seed storage proteins was developed by crossing a mutant donor line "HS99B" with a Chinese cultivar "Dongnong47" (DN47). One-dimensional and high-resolution 2-D gel electrophoresis revealed the absence of G1 (A1aB2), G2 (A2B1a), and G4 (A5A4B3) glycinin and the α' subunit of β-conglycinin in BSH-3 seeds. Despite the lack of these abundant seed proteins, BSH-3 seeds still accumulated 38% protein. BSH-3 seeds also accumulated high levels of free amino acids as compared with DN47 seeds, particularly arginine, and the amount of several essential amino acids were significantly elevated in BSH-3 seeds. Elevated accumulation of α and β-subunit of β-conglycinin, G5 glycinin, Kunitz trypsin inhibitor, and Bowman-Birk protease inhibitor indicates seed proteome rebalancing in BSH-3 seeds. Immunoblot analysis using sera from soybean allergic patients demonstrated the complete lack of a major allergen (α' subunit of β-conglycinin) in BSH-3 seeds. However, elevated levels of other allergens were found in BSH-3 seeds due to proteome rebalancing. Transmission electron microscopy observation of mature seeds of BSH-3 revealed striking differences in the appearance of the protein storage vacuoles when compared with DN47.