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Black soybean extract improves lipid profiles in fenofibrate-treated type 2 diabetics with postprandial hyperlipidemia.
Kusunoki, M, Sato, D, Tsutsumi, K, Tsutsui, H, Nakamura, T, Oshida, Y
Journal of medicinal food. 2015;(6):615-8
Abstract
Black soybeans (Glycine max (L.) Merr.) are known to be rich in polyphenols, including anthocyanins, and they have been consumed since ancient times for their beneficial effects on health. In addition, it has been reported that black soybean (BS) seed coat may ameliorate obesity and insulin resistance. In the present study, we administered BS extract to type 2 diabetics for 2 months to investigate the effects of BS on glycemic control and lipid metabolism parameters. In addition, we administered BS and antihyperlipidemic agent, fenofibrate, to patients with type 2 diabetes complicated by postprandial hyperlipidemia for 2 months and assessed the combined effects of fenofibrate and BS on serum lipid profile. The results showed that administration of the BS alone had no effect on the blood glucose or lipid levels, but that administration of fenofibrate alone and fenofibrate in combination with the BS significantly lowered their serum triglyceride (TG) level at fasting state, and the percent decrease in the serum TG level after combined administration was significantly higher than in the subjects who received fenofibrate alone. Furthermore, the serum LDL cholesterol concentration, which did not decrease when fenofibrate was administered alone, decreased significantly when the BS and fenofibrate were administered in combination. These results suggest that combined administration of the BS with fenofibrate enhanced the antihyperlipidemic action of fenofibrate, and the results of this study demonstrated the usefulness of the BS in clinical practice.
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Isoflavone pharmacokinetics and metabolism after consumption of a standardized soy and soy-almond bread in men with asymptomatic prostate cancer.
Ahn-Jarvis, JH, Clinton, SK, Grainger, EM, Riedl, KM, Schwartz, SJ, Lee, ML, Cruz-Cano, R, Young, GS, Lesinski, GB, Vodovotz, Y
Cancer prevention research (Philadelphia, Pa.). 2015;(11):1045-54
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Abstract
Epidemiologic associations suggest that populations consuming substantial amounts of dietary soy exhibit a lower risk of prostate cancer. A 20-week randomized, phase II, crossover trial was conducted in 32 men with asymptomatic prostate cancer. The crossover involved 8 weeks each of soy bread (SB) and soy-almond bread (SAB). The primary objective was to investigate isoflavone bioavailability and metabolite profile. Secondary objectives include safety, compliance, and assessment of biomarkers linked to prostate carcinogenesis. Two distinct SBs were formulated to deliver approximately 60 mg aglycone equivalents of isoflavones per day. The isoflavones were present as aglycones (∼78% as aglycones) in the SAB whereas in the standard SB predominantly as glucosides (18% total isoflavones as aglycones). Compliance to SB (97% ± 4%) and SAB (92% ± 18%) was excellent; toxicity was rare and limited to grade 1 gastrointestinal complaints. Pharmacokinetic studies between SB and SAB showed modest differences. Peak serum concentration time (Tmax) was significantly faster with SAB meal compared with SB in some isoflavonoids, and AUC0 to 24 h of dihydrodaidzein and O-desmethylangolensin was significantly greater after an SB meal. An exploratory cluster analysis was used to identify four isoflavone-metabolizing phenotypes. Insulin-like growth factor-binding protein increased significantly by 41% (P = 0.024) with soy intervention. Findings from this study provide the necessary framework to study isoflavone-metabolizing phenotypes as a strategy for identification of individuals that might benefit or show resistance to cancer preventive strategies using dietary soy. A standardized SB used for future large-scale randomized clinical trials to affect human prostate carcinogenesis is feasible.
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Consumption of soy isoflavone enriched bread in men with prostate cancer is associated with reduced proinflammatory cytokines and immunosuppressive cells.
Lesinski, GB, Reville, PK, Mace, TA, Young, GS, Ahn-Jarvis, J, Thomas-Ahner, J, Vodovotz, Y, Ameen, Z, Grainger, E, Riedl, K, et al
Cancer prevention research (Philadelphia, Pa.). 2015;(11):1036-44
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Abstract
We hypothesized that soy phytochemicals may have immunomodulatory properties that may affect prostate carcinogenesis and progression. A randomized, phase II trial was conducted in 32 patients with prostate cancer with asymptomatic biochemical recurrence but no measurable disease on standard staging studies. Patients were randomized to two slices of soy bread (34 mg isoflavones/slice) or soy bread containing almond powder daily as a source of β-glucosidase. Flow cytometry and bioplex assays were used to measure cytokines or immune cell phenotype in blood at baseline (day 0) and following intervention (day 56). Adequate blood samples were available at enrollment and day 56 and evaluated. Multiple plasma cytokines and chemokines were significantly decreased on day 56 versus baseline. Subgroup analysis indicated reduced TH1 (P = 0.028) and myeloid-derived suppressor cell (MDSC)-associated cytokines (P = 0.035). TH2 and TH17 cytokines were not significantly altered. Phenotypic analysis revealed no change in CD8(+) or CD4(+) T cells but showed increased CD56(+) natural killer (NK) cells (P = 0.038). The percentage of cells with a T regulatory cell phenotype (CD4(+)CD25(+)FoxP3(+)) was significantly decreased after 56 days of soy bread (P = 0.0136). Significantly decreased monocytic (CD33(+)HLADR(neg)CD14(+)) MDSC were observed in patients consuming soy bread (P = 0.0056). These data suggest that soy bread modulates systemic soluble and cellular biomarkers consistent with limiting inflammation and suppression of MDSCs. Additional studies to elucidate impact on the carcinogenic process or as a complement to immune-based therapy are required.
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Effects of short-term fructooligosaccharide intake on equol production in Japanese postmenopausal women consuming soy isoflavone supplements: a pilot study.
Tousen, Y, Uehara, M, Abe, F, Kimira, Y, Ishimi, Y
Nutrition journal. 2013;:127
Abstract
BACKGROUND Recent studies suggest that some of the clinical effectiveness of soy or daidzein, which is a type of isoflavone, may be attributed to a person's ability to produce equol from daidzein. Equol, which is a metabolite of one of the major soybean isoflavones called daidzein, is produced in the gastrointestinal tract by certain intestinal microbiota where present. Habitual dietary patterns may alter the intestinal bacterial profile, and influence the metabolism of isoflavones and the production of equol. Fructooligosaccharides (FOS) have a prebiotic activity as well as being a dietary fibre. The purpose of the present study was to determine whether FOS supplementation increases equol production in equol producers and stimulates equol production in equol non-producers in Japanese postmenopausal women. METHODS A soy challenge was used to assess equol-producer status prior to the start of the study in healthy postmenopausal Japanese women. The study involved 4 separate groups in randomised crossover design. First, subjects were classified as equol producers (n = 25) or non-producers (n = 18), and then they were randomly assigned to the FOS or control group. All subjects received a daily dose of 37 mg isoflavone conjugates in the capsule (21 mg aglycone form) and either FOS (5 g/day) or sucrose as control, in a randomised crossover study design. Equol -production was assessed by testing the serum and urine before and after the 2-week supplementation period. RESULTS The analyses were conducted on 34 subjects completed the study, 21 (61.8%) were classified as equol producers, and 13 (38.2%) as non-producers. Significant differences were observed in the interaction effect of time × equol state after 1 week of intervention (p = 0.006). However there were no effects after 2 weeks of intervention (p = 0.516). Finally, in both equol producers and non-producers, FOS supplementation did not affect the serum equol concentration or the urinary equol to daidzein concentration ratios. CONCLUSIONS We have reported that FOS intervention (5 g/day for 2 weeks) does not significantly modulate the capacity of intestinal microbiota to produce equol in postmenopausal Japanese women, in either equol producers or non-producers in this pilot study. Further larger investigations that explore the roles of specific intestinal microbiota in equol production will enable the establishment of dietary conditions that are required to enhance equol production.
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[Using of a specialized fermented soy milk product on the basis of soybeans in cardiology practice].
Siniavskiĭ, IuA, Kraĭsman, VA, Suleĭmenova, ZhM
Voprosy pitaniia. 2013;(5):51-7
Abstract
The article is dedicated to the use of a specialized fermented milk product on the basis of soybeans in cardiology practice. 45 patients of both sexes (27 men and 18 women) aged 38 to 69 years (mean age 53.7 +/- 3.1 years) who underwent macrofocal myocardial infarction and abide in the acute period and the period of early rehabilitation have been observed. The data obtained by the comparison of the dynamics of clinical, laboratory and functional parameters in patients, strongly suggests the possibility of increasing the effectiveness of the basic treatment by anti-atherogenic diet with fermented soy drink, enriched with magnesium salts, water-soluble forms of beta-carotene and alpha-tocopherol, ascorbic acid and selenium. 30-35 day inclusion of a fermented soy-based product in comprehensive treatment was accompanied by a marked lipid lowering effect, compared with the standard anti-atherogenic diet. Total cholesterol level in patients from the intervention group (n = 21) decreased by 36.3 per cent, thus reaching the standard level, the corresponding figure in the control group (n = 24) decreased by 24.7 per cent (the difference is statistically significant). Total number of rhythm and conduction disorders in patients receiving product was 1.43 per patient, while it reached 1.83 per patient on the basic therapy and a standard diet. The vast majority were beats, no cases of ventricular fibrillation and one case of atrioventricular block took place in patients from the experimental group. Paroxysmal and atrial fibrillation in the control group of patients were recorded 2 fold more often than in the main group. In addition, three cases of ventricular fibrillation were reported in patients from the control group. Early usage of soy drink 3 fold reduced the incidence of complications in the 10-14 day from the moment of macrofocal myocardial infarction. The frequency of angina attacks per week per patient more significantly reduced under nutritional support, compared with patients receiving standard therapy and diet. The decrease of mean number of nitroglycerin tablets taken per week for one person from the experimental group was equal to 9.0 fold, and in the control group--2.43, this demonstrates a significant strengthening of the effectiveness of basic therapy with early administration of soy product. The recovery of ischemic changes in the electrocardiogram in patients receiving soy product was significantly decreased compared with those receiving standard therapy and anti-atherogenic diet, the degree of reduction in the intervention group was 43.3%, while in the control group--27.5%. These data indicate that the use of soy product in a comprehensive early rehabilitation therapy of patients with macrofocal myocardial infarction significantly reduces the risk of arrhythmias and conduction.
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Soy isoflavone supplementation for breast cancer risk reduction: a randomized phase II trial.
Khan, SA, Chatterton, RT, Michel, N, Bryk, M, Lee, O, Ivancic, D, Heinz, R, Zalles, CM, Helenowski, IB, Jovanovic, BD, et al
Cancer prevention research (Philadelphia, Pa.). 2012;(2):309-19
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Soy isoflavone consumption may protect against breast cancer development. We conducted a phase IIB trial of soy isoflavone supplementation to examine its effect on breast epithelial proliferation and other biomarkers in the healthy high-risk breast. One hundred and twenty-six consented women underwent a random fine-needle aspiration (rFNA); those with 4,000 or more epithelial cells were randomized to a double-blind 6-month intervention of mixed soy isoflavones (PTIG-2535) or placebo, followed by repeat rFNA. Cells were examined for Ki-67 labeling index and atypia. Expression of 28 genes related to proliferation, apoptosis, and estrogenic effect was measured using quantitative reverse transcriptase PCR. Hormone and protein levels were measured in nipple aspirate fluid (NAF). All statistical tests were two-sided. Ninety-eight women were evaluable for Ki-67 labeling index. In 49 treated women, the median Ki-67 labeling index was 1.18 at entry and 1.12 post intervention, whereas in 49 placebo subjects, it was 0.97 and 0.92 (P for between-group change: 0.32). Menopausal stratification yielded similar results between groups, but within premenopausal soy-treated women, Ki-67 labeling index increased from 1.71 to 2.18 (P = 0.04). We saw no treatment effect on cytologic atypia or NAF parameters. There were significant increases in the expression of 14 of 28 genes within the soy, but not the control group, without significant between-group differences. Plasma genistein values showed excellent compliance. A 6-month intervention of mixed soy isoflavones in healthy, high-risk adult Western women did not reduce breast epithelial proliferation, suggesting a lack of efficacy for breast cancer prevention and a possible adverse effect in premenopausal women.
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Effects of soybean peptide on immune function, brain function, and neurochemistry in healthy volunteers.
Yimit, D, Hoxur, P, Amat, N, Uchikawa, K, Yamaguchi, N
Nutrition (Burbank, Los Angeles County, Calif.). 2012;(2):154-9
Abstract
OBJECTIVE Soybeans, an excellent source of dietary peptides, have beneficial effects on health. We investigated the effect of the soybean peptide on immune function, brain function, and neurochemistry in healthy volunteers. METHODS Near-infrared spectroscopy (NIRS) was used to analyze brain cerebral blood flow. The A and DA levels in the serum were analyzed by ELISA kit. The total number of leukocytes was recorded with a standard counter. Flow cytometry was used to assess lymphocyte subset levels. RESULTS Cell numbers were upregulated in the group that had fewer leukocytes but downregulated in the group with more leukocytes. For the lymphocyte-rich type, lymphocyte counts tended to decrease, accompanied by an increase in granulocyte numbers. For the granulocyte-rich type, granulocyte counts tended to increase, but lymphocyte counts also increased. The numbers of CD11b(+) cells and CD56(+) cells increased significantly. Soybean peptide decreased the adrenalin level in plasma but increased the level of dopamine. Near-infrared spectroscopy showed significant increases in the amplitudes of θ, α-2, and β-L frequency bands after the ingestion of peptides. CONCLUSION Soybean peptides can modulate cellular immune systems, regulate neurotransmitters, and boost brain function.
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Serum IGF-1 concentrations change with soy and seaweed supplements in healthy postmenopausal American women.
Teas, J, Irhimeh, MR, Druker, S, Hurley, TG, Hébert, JR, Savarese, TM, Kurzer, MS
Nutrition and cancer. 2011;(5):743-8
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Insulin-like growth factor 1 (IGF-1) is an anabolic hormone important for growth and development. However, high-circulating serum concentrations in adults are associated with increased risk of postmenopausal breast cancer. Nutritional status and specific foods influence serum IGF-1 concentrations. Breast cancer incidence is typically low in Asian countries where soy is commonly consumed. Paradoxically, soy supplement trials in American women have reported significant increases in IGF-1. Seaweed also is consumed regularly in Asian countries where breast cancer risk is low. We investigated the possibility that seaweed could modify soy-associated increases in IGF-1 in American women. Thirty healthy postmenopausal women (mean age 58 yr) participated in this 14-wk double-blinded, randomized, placebo-controlled crossover clinical trial. Participants consumed 5 g/day placebo or seaweed (Alaria esculenta) in capsules for 7 wk. During the 7th wk, a high-soy protein isolate powder was added (2 mg/kg body weight aglycone equivalent isoflavones). Overnight fasting blood samples were collected after each intervention period. Soy significantly increased serum IGF-1 concentrations compared to the placebo (21.2 nmol/L for soy vs. 16.9 nmol/L for placebo; P = 0.0001). The combination of seaweed and soy significantly reduced this increase by about 40% (21.2 nmol/L for soy alone vs. 19.4 nmol/L; P = 0.01). Concurrent seaweed and soy consumption may be important in modifying the effect of soy on IGF-1 serum concentrations.
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The effect of soy-derived isoflavones over hot flushes, menopausal symptoms and mood in climacteric women with increased body mass index.
Chedraui, P, San Miguel, G, Schwager, G
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology. 2011;(5):307-13
Abstract
BACKGROUND Risk-benefit issues raised after the WHI have significantly increased the use of alternative treatments for the menopause. Despite this, data regarding the effect of soy isoflavones over mood and menopausal symptoms in high risk populations is still lacking. OBJECTIVE To evaluate the effect of soy derived isoflavones over hot flushes, menopausal symptoms and mood in climacteric women with increased body mass index (BMI). METHODS Fifty symptomatic climacteric women aged 40 to 59 with increased BMI (≥ 25) were recruited to receive oral 100 mg/day of soy derived isoflavones (Climasoy) for 3 months. Hot flushes (frequency/intensity), menopausal symptoms (Menopause Rating Scale [MRS]) and mood (Hamilton Depressive Rating Scale [HDRS]) were evaluated at baseline and at 90 days. RESULTS A total of 45 women completed the study. After 3 months of soy isoflavone supplementation hot flushes significantly decreased in percentage, number and severity (100% to 31.1%; 3.9 ± 2.3 to 0.4 ± 0.8 and 2.6 ± 0.9 to 0.4 ± 0.8, respectively, p < 0.001). MRS scores (total and for subscales) reflecting general menopausal symptoms also significantly decreased compared to baseline. Regarding mood, after three months total HDRS scores and the rate of women presenting depressed mood (scores ≥ 8) significantly decreased (16.3 ± 5.4 to 6.9 ± 5.2 and 93.3% to 28.9%, respectively, p < 0.05). There was no effect on blood pressure levels or BMI values after treatment. CONCLUSION In this high risk climacteric population, soy derived isoflavone treatment improved mood as well as vasomotor and general menopausal symptoms. More research is required to determine if the positive effect over mood is a direct or an indirect one through hot flush alleviation.
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Product-evaluation registry of Meriva®, a curcumin-phosphatidylcholine complex, for the complementary management of osteoarthritis.
Belcaro, G, Cesarone, MR, Dugall, M, Pellegrini, L, Ledda, A, Grossi, MG, Togni, S, Appendino, G
Panminerva medica. 2010;(2 Suppl 1):55-62
Abstract
AIM: A proprietary complex of curcumin with soy phosphatidylcholine (Meriva®, Indena SpA) was evaluated in a registry study to define its efficacy in 50 patients with osteoarthritis (OA) at dosages corresponding to 200 mg curcumin per diem. METHODS OA signs/symptoms were evaluated by the WOMAC scores. Mobility was studied by walking performance (treadmill), and inflammatory status was assessed by measurements of C-reactive protein (CRP). RESULTS After three months of treatment, the global WOMAC score decreased by 58% (P<0.05), walking distance in the treadmill test was prolonged from 76 m to 332 m (P<0.05), and CRP levels decreased from 168 +/- 18 to 11.3 +/-. 4.1 mg/L in the subpopulation with high CRP. In comparison, the control group experienced only a modest improvement in these parameters (2% in the WOMAC score, from 82 m to 129 m in the treadmill test, and from 175 +/- 12.3 to 112 +/- 22.2 mg/L in the CRP plasma concentration), while the treatment costs (use of anti-inflammatory drugs, treatment and hospitalization) were reduced significantly in the treatment group. CONCLUSION These results show that Meriva® is clinically effective in the management and treatment of osteoarthritis and suggest that the increased stability and better absorption of curcumin induced by complexation with phospholipids have clinical relevance, setting the stage for larger and more prolonged studies.