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N-SORB,一种专有的 KD120 MEC 代谢激活酶配方的安全性和疗效:一项随机、双盲、安慰剂对照研究。

Safety and Efficacy of N-SORB, a Proprietary KD120 MEC Metabolically Activated Enzyme Formulation: A Randomized, Double-Blind, Placebo-Controlled Study.

机构信息

School of Pharmacy, University of Wyoming , Laramie , Wyoming , USA.

Department of Kinesiology and Health, University of Wyoming , Laramie , Wyoming , USA.

出版信息

J Am Coll Nutr. 2019 Sep-Oct;38(7):577-585. doi: 10.1080/07315724.2019.1586591. Epub 2019 Apr 11.


DOI:10.1080/07315724.2019.1586591
PMID:30971174
Abstract

Enzymes are crucial for all aspects of metabolic function. Digestive enzymes from natural sources have been credited with beneficial effects in the digestion and absorption of food. N-SORB is a novel KD120 multienzyme complex (MEC) of metabolically activated enzymes composed of proteases, amylases, lipases, alpha-galactosidase, and glucoamylase from natural sources. These enzymes are encapsulated in a SK713 SLP (non-GMO soy lecithin phospholipid) absorption technology (Prodosome). This randomized, double-blind placebo-controlled investigation assessed the safety and efficacy of N-SORB KD120 MEC in healthy male and female volunteers on various parameters of the blood, immunity, body composition, physical health, and quality of life following a 90-day intervention. Forty-six male and female (mean age: 25.8 ± 12.1 years) healthy volunteers were randomly assigned to receive either N-SORB (1 mL, twice daily) or placebo for 90 consecutive days. Complete blood count, as well as blood glucose, liver enzymes, and lipid profile were assessed pre- and post-intervention. Serum cytokine levels were determined by using a Bio-Plex Pro Human Cytokine 8-plex assay and enzyme linked immunosorbent assay (ELISA). Whole body composition analysis was performed by dual-energy x-ray absorptiometry (DEXA) to determine body fat mass, lean mass, and android and gynoid fat. Body weight, blood pressure, and physical health were assessed. Changes in quality of life were examined using the World Health Organization Quality of Life-abbreviated version and sleep quality was assessed using the 24-item Pittsburgh Sleep Quality Index (PSQI) questionnaire. Adverse events were monitored before, during, and after completion of the study. Of the 46 subjects enrolled, a total of 40 subjects successfully completed the study. Compared to placebo, changes in blood cell counts including hematocrit, hemoglobin, mean corpuscular volume, platelets, and lymphocytes provide evidence of some improvement. Quality of life (QOL) parameters showed a small but significant improvement in the N-SORB group. A significant increase was observed in aspartate aminotransferase level in the placebo group at the end of 90 days of treatment; however, no increase was observed in the N-SORB group. No significant changes in blood urea nitrogen, serum creatinine, alkaline phosphatase, alanine aminotransferase, and lipid profile were observed between the placebo and treatment groups before and following intervention. No adverse effects were reported. This randomized, double blind, placebo-controlled clinical study demonstrates that short-term intervention with N-SORB improves the QOL and PSQI in healthy volunteers and did not significantly alter cardiometabolic parameters, lipid profile, or body composition.

摘要

酶对新陈代谢的各个方面都至关重要。天然来源的消化酶被认为对食物的消化和吸收有益。N-SORB 是一种新型的 KD120 多酶复合物(MEC),由天然来源的蛋白酶、淀粉酶、脂肪酶、α-半乳糖苷酶和葡萄糖淀粉酶组成。这些酶被包裹在 SK713 SLP(非转基因大豆卵磷脂磷脂)吸收技术(Prodosome)中。 这项随机、双盲、安慰剂对照研究评估了 N-SORB KD120 MEC 在 90 天干预后对健康男性和女性志愿者血液、免疫、身体成分、身体健康和生活质量的各种参数的安全性和有效性。46 名男性和女性(平均年龄:25.8±12.1 岁)健康志愿者被随机分配接受 N-SORB(1 毫升,每天两次)或安慰剂治疗 90 天。在干预前后评估了全血细胞计数以及血糖、肝酶和血脂谱。通过使用 Bio-Plex Pro 人类细胞因子 8 合子测定法和酶联免疫吸附测定法(ELISA)测定血清细胞因子水平。通过双能 X 射线吸收法(DEXA)进行全身成分分析,以确定体脂肪量、瘦体重以及安卓和女性脂肪。评估了体重、血压和身体健康状况。使用世界卫生组织生活质量简明版和匹兹堡睡眠质量指数(PSQI)问卷评估了生活质量的变化。监测了研究完成前后的不良事件。 在纳入的 46 名受试者中,共有 40 名受试者成功完成了研究。与安慰剂相比,包括红细胞压积、血红蛋白、平均红细胞体积、血小板和淋巴细胞在内的血细胞计数的变化提供了一些改善的证据。N-SORB 组的生活质量(QOL)参数也显示出较小但有意义的改善。在安慰剂组中,在 90 天治疗结束时观察到天门冬氨酸氨基转移酶水平显著升高;然而,在 N-SORB 组中没有观察到这种升高。在干预前后,安慰剂和治疗组之间的血尿素氮、血清肌酐、碱性磷酸酶、丙氨酸氨基转移酶和血脂谱均无明显变化。没有报告不良反应。 这项随机、双盲、安慰剂对照的临床研究表明,N-SORB 的短期干预可提高健康志愿者的生活质量和 PSQI,且不会显著改变心脏代谢参数、血脂谱或身体成分。

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