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A local-ingredients-based supplement is an alternative to corn-soy blends plus for treating moderate acute malnutrition among children aged 6 to 59 months: A randomized controlled non-inferiority trial in Wolaita, Southern Ethiopia.
Nane, D, Hatløy, A, Lindtjørn, B
PloS one. 2021;(10):e0258715
Abstract
BACKGROUND Globally, moderate acute malnutrition (MAM) affects approximately 5% of children below five years of age. MAM is a persistent public health problem in Ethiopia. The current approach in Ethiopia for managing MAM is a supplementary feeding program; however, this is only provided to chronically food-insecure areas. The objective of the study was to compare a local-ingredients-based supplement (LIBS) with the standard corn-soy blend plus (CSB+) in treating MAM among children aged 6 to 59 months to test the hypothesis that the recovery rate achieved with LIBS will not be more than 7% worse than that achieved with CSB+. METHODS AND FINDINGS We used an individual randomized controlled non-inferiority trial design with two arms, involving 324 children with MAM aged 6 to 59 months in Wolaita, Southern Ethiopia. One hundred and sixty-two children were randomly assigned to each of the two arms. In the first arm, 125.2 g of LIBS with 8 ml of refined deodorized and cholesterol-free sunflower oil/day was provided. In the second arm, 150 g of CSB+ with 16 ml of refined deodorized and cholesterol-free sunflower oil/day was provided. Each child was provided with a daily ration of either LIBS or CSB+ for 12 weeks. Both intention-to-treat (ITT) and per-protocol (PP) analyses were done. ITT and PP analyses showed non-inferiority of LIBS compared with CSB+ for recovery rate [ITT risk difference = 4.9% (95% CI: -4.70, 14.50); PP risk difference = 3.7% (95% CI: -5.91, 13.31)]; average weight gain [ITT risk difference = 0.10 g (95% CI: -0.33 g, 0.53 g); PP risk difference = 0.04 g (95% CI: -0.38 g, 0.47 g)]; and recovery time [ITT risk difference = -2.64 days (95% CI: -8.40 days, 3.13 days); PP difference -2.17 days (95% CI: -7.97 days, 3.64 days]. Non-inferiority in MUAC gain and length/height gain was also observed in the LIBS group compared with the CSB+ group. CONCLUSIONS LIBS can be used as an alternative to the standard CSB+ for the treatment of MAM. Thus, the potential of scaling up the use of LIBS should be promoted. TRIAL REGISTRATION Pan-African Clinical Trial Registration number: PACTR201809662822990.
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The effect of soy isoflavone combined with calcium on bone mineral density in perimenopausal Chinese women: a 6-month randomised double-blind placebo-controlled study.
Zhang, X, Liu, Y, Xu, Q, Zhang, Y, Liu, L, Li, H, Li, F, Liu, Z, Yang, X, Yu, X, et al
International journal of food sciences and nutrition. 2020;(4):473-481
Abstract
This study was a prospective, randomised, double-blind, placebo-controlled clinical trial and aimed to compare the effect of placebo, soy isoflavone, calcium and soy isoflavone combined with calcium on bone mineral density (BMD). One hundred and sixty perimenopausal women with osteoporosis or osteopenia were enrolled and randomised into four groups: control, soy isoflavone, calcium and soy isoflavone combined with calcium groups. After intervention, compared with control, isoflavone and calcium groups, mean changes from their corresponding baseline values of BMD, calcium/phosphorus, vitamin D and glutathione peroxidase (GSH-pX) activity were significantly increased, however, those of phosphorus, osteocalcin, luteinizing hormone (LH) and follicle stimulating hormone (FSH) were significantly decreased in isoflavone combined with calcium group. The results showed that soy isoflavone, calcium and isoflavone combined with calcium therapy were effective and safe on attenuating BMD loss in perimenopausal women and isoflavone combined with calcium therapy was better than soy isoflavone and calcium alone.
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Metabolic tracking of isoflavones in soybean products and biosamples from healthy adults after fermented soybean consumption.
Jang, HH, Noh, H, Kim, HW, Cho, SY, Kim, HJ, Lee, SH, Lee, SH, Gunter, MJ, Ferrari, P, Scalbert, A, et al
Food chemistry. 2020;:127317
Abstract
Fermentation may enhance the nutritional properties of foods by increasing metabolite bioactivity or bioavailability. This study explored the effect of fermentation on isoflavone bioavailability and metabolism. Isoflavone metabolites were tracked in foods and biospecimens of healthy adults after fermented soybean (FS) or non-fermented soybean (NFS) consumption in a randomized, controlled, crossover intervention study. The change in soybean isoflavones caused by fermentation resulted in faster absorption and higher bioavailability after consumption of FS. Although the urinary level of total isoflavone metabolites was similar after the consumption of the two diets, urinary genistein 7-O-sulfate was derived as a discriminant metabolite for the FS diet by partial least squares discriminant analysis. This study suggests that an isoflavone conjugate profile might be a more appropriate marker than total isoflavone levels for discriminating between the consumption of FS and NFS diets.
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Effect of whole soy and purified daidzein on androgenic hormones in chinese equol-producing post-menopausal women: a six-month randomised, double-blinded and Placebo-Controlled trial.
Liu, ZM, Li, G, Zhang, D, Ho, SC, Chen, YM, Ma, J, Huang, Q, Li, S, Ling, WH
International journal of food sciences and nutrition. 2020;(5):644-652
Abstract
A randomised, double-blind and placebo-controlled trial was performed to examine the effects of whole soy and isoflavone daidzein on serum androgenic hormones in Chinese equol-producing post-menopausal women. A total of 270 eligible women aged 45-70 years were randomised to either one of the three iso-caloric supplements: 40 g soy flour (whole soy group), 40 g low-fat milk powder +63 mg daidzein (daidzein group) or 40 g low-fat milk powder (placebo group) daily for 6 months. Fasting venous samples were tested for serum androstenedione (AD), testosterone (T), prolactin, sex hormone binding globulin and dehydroepiandrosterone sulphate. Intention-to-treat analysis indicated that serum T (p = .022) and AD (p = .05) levels modestly but significantly decreased after 6-month daidzein treatment in comparison with placebo, with a mean difference of -0.057 nmol/L (95%CI: -0.185 to 0.070, p = .018) and -0.118 ng/mL (95%CI: -0.240-0.004, p = .045), respectively. This 6-month trial suggested that purified daidzein may exhibit less androgenic effect.Trial registration: The trial was registered in ClinicalTrials.gov with identifier of NCT01270737. (URL: http://clinicaltrials.gov/ct2/show/NCT01270737.).
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Acute Soy Supplementation Improves 20-km Time Trial Performance, Power, and Speed.
Seeley, AD, Jacobs, KA, Signorile, JF
Medicine and science in sports and exercise. 2020;(1):170-177
Abstract
INTRODUCTION Isoflavones, a chemical class of phytoestrogens found in soybeans and soy products, may have biological functions similar to estradiol. After binding with ERβ or perhaps independently of estrogen receptors, isoflavones may augment vascular endothelial relaxation, contributing to improved limb blood flow. PURPOSE To determine if acute fermented soy extract supplementation influences 20-km time trial cycling performance and cardiac hemodynamics compared with a placebo. METHODS Subjects included 25 cyclists and triathletes (31 ± 8 yr, V˙O2peak: 55.1 ± 8.4 mL·kg·min). Each subject completed a V˙O2peak assessment, familiarization, and two 20-km time trials in randomized order after ingestion of a fermented soy extract supplement or placebo. The fermented soy extract consisted of 30 g powdered supplement in 16 fl. ounces of water. The placebo contained the same quantities of organic cocoa powder and water. Each trial consisted of 60 min of rest, 30 min at 55% Wpeak, and a self-paced 20-km time trial. RESULTS Soy supplementation elicited a faster time to 20-km completion (-0.22 ± 0.51 min; -13 s), lower average HR (-5 ± 7 bpm), and significantly greater power (7 ± 3 W) and speed (0.42 ± 0.16 km·h) during the last 5 km of the time trial compared with placebo. Analysis of the results by relative fitness level (<57 vs ≥ 57 mL⋅kg⋅min) indicated that those with a higher level of fitness reaped the largest performance improvement alongside a reduced HR (-5 ± 7 bpm). CONCLUSIONS Ingestion of a fermented soy extract supplement improved sprint-distance performance through improvements in both power and speed. For those with great aerobic fitness, soy supplementation may help to decrease cardiac demand alongside performance improvement.
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The effect of soy nut on serum total antioxidant, endothelial function and cardiovascular risk factors in patients with type 2 diabetes.
Sedaghat, A, Shahbazian, H, Rezazadeh, A, Haidari, F, Jahanshahi, A, Mahmoud Latifi, S, Shirbeigi, E
Diabetes & metabolic syndrome. 2019;(2):1387-1391
Abstract
BACKGROUND Type 2 diabetes has a high spread and growing process. Using appropriate food diets is among therapeutic approaches has been applied for diabetic patients. Soya utilization has shown effective results in controlling metabolic abnormalities of these patients. The aim of this study is to investigate the effects of soy nut on glycemic conditions, blood pressure, lipid profile, antioxidant effects and vascular endothelial function of these patients. METHODS 70 patients with type 2 diabetes were randomly divided into two groups of the test (35 people) and control (35 people). The patients in the intervention group were subjected to 60 g soy nut diet as a part of daily protein for 8 weeks and the control group under the usual diet of diabetes. The fasting glucose, blood pressure, lipid profile, brachial blood flow, the level of serum E-Selectin and total antioxidant capacity in control and test group were assessed before and after diet. RESULTS Consuming 60 g soy nut for 8 weeks significantly decreased the fasting blood glucose (P = 0.03), total serum cholesterol (P < 0.01), LDL-c (P = 0.01), and E-Selectin (P < 0.01) and increased the capacity of serum total antioxidants (P < 0.01), brachial blood flow (P < 0.01) but didn't have any significant effect on systolic/diastolic blood pressure, HDL-c, and TG. CONCLUSION Soy nut utilization in the patients with type-2 diabetes can significantly improve the glycemic condition, increase brachial blood flow, decrease E-selectin (improvement of endothelial function), increase serum total antioxidants and lipid profile but has no significant effect on blood pressure and HDL-c.
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Novel effects of phytoestrogenic soy isoflavones on serum calcium and chloride in premenopausal women: A 2-year double-blind, randomized, placebo-controlled study.
Lu, LW, Chen, NW, Nayeem, F, Ramanujam, VS, Kuo, YF, Brunder, DG, Nagamani, M, Anderson, KE
Clinical nutrition (Edinburgh, Scotland). 2018;(6 Pt A):1862-1870
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Abstract
BACKGROUND Soy phytoestrogens are potential alternatives to postmenopausal hormone replacement therapy (HRT). Adverse effects of HRT such as myocardial infarction, stroke, and pulmonary embolism are mediated by calcium-induced signaling. OBJECTIVE To determine whether soy isoflavones affect serum calcium in healthy female subjects. DESIGN In a double-blind trial, 197 premenopausal women were randomly assigned to either isoflavone (N = 99) or placebo pills (N = 98) 5 days per week for up to 2 years, plus prenatal vitamins. Isoflavone pills contained 60 mg genistein, 60 mg daidzein and 16.6 mg glycitein (expressed as aglycone equivalents). All pills contained 15 mg riboflavin as an adherence marker. Blood chemistries and urinary daidzein, genistein and riboflavin were measured multiple times during the luteal phase before and during treatment. RESULTS Analysis of the adherent population (N = 83 per group), revealed significantly strong associations between urinary levels of isoflavones and serum concentrations of calcium (regression coefficients 0.082 for daidzein and 0.229 for genistein, all P < 0.01) and chloride (regression coefficient, -1.537 for genistein, P < 0.0001), mediated in part by albumin. The effects amounted to mean changes of +0.24 mg/dL for calcium and -1.45 mEq/L for chloride, with each visit for subjects excreting the most vs. the least amounts of isoflavones. These associations were not evident in the intention-to-treat analysis (N = 197) that did not assess expected variations in isoflavone levels within and between subjects from metabolism and adherence. CONCLUSIONS These novel and strong effects of soy isoflavones on calcium homeostasis have important implications for long term effects of these natural substances on cardiovascular diseases.
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PPARγ2 C1431T Polymorphism Interacts with the Antiobesogenic Effects of Kochujang, a Korean Fermented, Soybean-Based Red Pepper Paste, in Overweight/Obese Subjects: A 12-Week, Double-Blind Randomized Clinical Trial.
Lee, Y, Cha, YS, Park, Y, Lee, M
Journal of medicinal food. 2017;(6):610-617
Abstract
Kochujang, a Korean fermented soybean-based red pepper paste, has been reported to have beneficial health effects. The aim of this study was to examine the antiobesity effects of Kochujang as a supplement in overweight/obese subjects according polymorphisms in the obesity-linked gene, peroxisome proliferator activator receptor γ (PPARγ2). Sixty overweight/obese subjects, who had body mass indexes (BMI, kg/m2) ≥23 or waist/hip ratios (WHR) ≥0.90 for males or ≥0.85 for females, were randomly assigned to either taking 32 g/day of placebo or Kochujang for 12 weeks. Before and after the intervention, anthropometric and metabolic parameters and body fat distribution (by computed tomography) were measured. After PPARγ2 C1431T polymorphism was analyzed by PCR-restriction fragment length polymorphism, the differences among the four groups (wild and mutant alleles in Kochujang and placebo groups) were determined. Between the Kochujang (n = 26) and placebo (n = 27) groups, there were no differences in body composition, insulin resistance, or antioxidant biomarkers before and after intervention. Compared to placebo, Kochujang significantly decreased plasma triglyceride (TG), TG/high-density lipoprotein (HDL), and dietary intakes of protein, sodium, and potassium after age, sex, and BMI were adjusted. The beneficial effects of Kochujang on lowering of TG and TG/HDL were weakened in subjects with the PPARγ2 mutant T allele with increasing subcutaneous fat area. However, the interaction between Kochujang and the PPARγ2 T allele improved insulin sensitivity. The obesogenic variables affected by the T mutant allele of PPARγ2 C1431T SNP were different in overweight/obese subjects in response to Kochujang.
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Evaluation of Levothyroxine Bioavailability after Oral Administration of a Fixed Combination of Soy Isoflavones in Post-menopausal Female Volunteers.
Persiani, S, Sala, F, Manzotti, C, Colovic, M, Zangarini, M, Donazzolo, Y, Barbetta, B, Vitalini, C, Giacovelli, G, Benvenuti, C, et al
Drug research. 2016;(3):136-40
Abstract
BACKGROUND Post-menopausal women under treatment with levothyroxine for their medical conditions may take concomitantly dietary supplements containing soy isoflavones in combination to treat their post-menopausal symptoms. The aim of this study was to investigate the effect of a fixed combination of soy isoflavones on the oral bioavailability of levothyroxine in post-menopausal female volunteers. METHODS 12 healthy post-menopausal female, who were on stable oral levothyroxine as replacement/supplementation therapy for hypothyroidism, received a single recommended oral dose of a food supplement containing 60 mg of soy isoflavones (>19% genistin and daidzin) concomitantly with (test) and 6 h later (reference) the administration of levothyroxine in a randomized, open label, crossover fashion. Plasma concentrations of levothyroxine and soy isoflavones (daidzin, daidzein, genistin, genistein, S-equol) were determined by LC-MS/MS. Pharmacokinetic (PK) parameters were determined by non-compartmental analysis. No effect of soy isoflavones was assumed if the 90% confidence intervals (CIs) for the estimated ratio test/reference was included in the acceptance limits 0.80-1.25 for PK parameters Cmax and AUCt. RESULTS The test/reference ratios Cmax and AUCt of levothyroxine were very close to unity (1.02 and 0.99, respectively) and the corresponding 90% CIs (0.99-1.04 and 0.88-1.12, respectively) fell entirely within the acceptance bioequivalence limits. CONCLUSION The combination of soy isoflavones used in the present investigation does not affect the rate and extent of levothyroxine absorption when administered concomitantly in post-menopausal women.
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Beneficial Effects of Pterocarpan-High Soybean Leaf Extract on Metabolic Syndrome in Overweight and Obese Korean Subjects: Randomized Controlled Trial.
Ryu, R, Jeong, TS, Kim, YJ, Choi, JY, Cho, SJ, Kwon, EY, Jung, UJ, Ji, HS, Shin, DH, Choi, MS
Nutrients. 2016;(11)
Abstract
Pterocarpans are known to have antifungal and anti-inflammatory properties. However, little is known about the changes in transcriptional profiles in response to a pterocarpan-high soybean leaf extract (PT). Therefore, this study investigated the effects of PT on blood glucose and lipid levels, as well as on the inflammation-related gene expression based on a peripheral blood mononuclear cells (PBMCs) mRNA sequencing analysis in Korean overweight and obese subjects with mild metabolic syndrome. The participants were randomly assigned to two groups and were administered either placebo (starch, 3 g/day) or PT (2 g/day) for 12 weeks. The PT intervention did not change body weight, body fat percentage and body mass index (BMI). However, PT significantly decreased the glycosylated hemoglobin (HbA1c), plasma glucose, free fatty acid, total cholesterol, and non-HDL cholesterol levels after 12 weeks. Furthermore, PT supplementation significantly lowered the homeostatic index of insulin resistance, as well as the plasma levels of inflammatory markers. Finally, the mRNA sequencing analysis revealed that PT downregulated genes related to immune responses. PT supplementation is beneficial for the improvement of metabolic syndrome by altering the fasting blood and plasma glucose, HbA1c, plasma lipid levels and inflammation-related gene expression in PBMCs.