营养保健品组合物（酵母 β-葡聚糖、益生元、矿物质和水飞蓟素）可预测睡眠质量和代谢参数的改善：一项随机先导研究。
Nutraceutical composition (yeast β-glucan, prebiotics, minerals, and silymarin) predicts improvement of sleep quality and metabolic parameters: A randomized pilot study.
机构信息
Laboratório de Produtos e Derivados Naturais, Laboratório de Investigação Médica-26 (LIM-26), Departamento de Cirurgia, Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP 01246903, Brazil; Pesquisa e Desenvolvimento Efeom Nutrição S/A, São Paulo, SP 03317-000, Brazil; Departamento de Biociências, Universidade Federal de São Paulo (UNIFESP), Santos, SP 11015-020, Brazil.
Laboratório de Produtos e Derivados Naturais, Laboratório de Investigação Médica-26 (LIM-26), Departamento de Cirurgia, Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP 01246903, Brazil; Pesquisa e Desenvolvimento Efeom Nutrição S/A, São Paulo, SP 03317-000, Brazil.
出版信息
Clin Nutr ESPEN. 2024 Oct;63:476-490. doi: 10.1016/j.clnesp.2024.06.033. Epub 2024 Jul 2.
BACKGROUND & AIMS: The search for integrative and natural therapies that favor homeostasis to boost sleep and diet quality took place for young adult populations as a non-pharmacological strategy for long-term good quality of life. Thus, the present pilot study aims to investigate the effects of 90-day consumption of a nutraceutical composition on the neuro-immune-endocrine axis, providing better sleep quality and health improvement.
METHODS
For this, from March 2021 to June 2021, twenty-two Brazilian young adult volunteers (women and men) with BMI between 18.5 and 34.9 kg/m were divided into three distinct supplementation groups: NSupple; NSupple plus_S, and NSupple plus. Briefly, the supplement compositions included yeast β-glucan, prebiotics, and minerals in different concentrations associated or not with the herbal medicine silymarin. Neither nutritional nor physical activity interventions were performed during this pilot study period. The anthropometrics measures, questionnaires answer data, and harvest blood for metabolic, inflammatory, and hormonal tests were collected at baseline time (day zero-T0) and day 90 (T90) post-supplementation.
RESULTS
Our results highlight that the supplementation reduced body mass index (BMI), Waist-to-height ratio (WHtR), waist circumference, AST/ALT ratio, alkaline phosphatase, and HbA1c. Post-supplementation the IL-6 and IL-10 levels and the sleep, humor, and quality of life scores were suggested to improve. Sleep quality improvement seems to predict the reduction of adiposity-related body measures.
CONCLUSION
In sum, the nutraceutical supplementation might be related to anthropometric, metabolic, and endocrine parameters after 90 days reflecting on perception of humor, sleep, and life quality enhancement. However, it is important to recognize the limitation of the data presented considering that this was a pilot study.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, identifier NCT04810572 registered on 20th February 2021.
背景与目的
为了寻找有利于体内平衡的综合和自然疗法，以提高睡眠和饮食质量，年轻人群体将非药物策略作为长期高质量生活的一种选择。因此，本初步研究旨在调查 90 天食用营养补充剂组合物对神经-免疫-内分泌轴的影响，提供更好的睡眠质量和健康改善。
方法
为此，2021 年 3 月至 2021 年 6 月，22 名巴西年轻成年志愿者（男女）的 BMI 在 18.5 至 34.9kg/m 之间，分为三个不同的补充组：NSupple；NSupple plus_S 和 NSupple plus。简而言之，补充剂组合物包括酵母 β-葡聚糖、益生元和矿物质，浓度不同，与草药水飞蓟素相关或不相关。在这个初步研究期间，没有进行营养或体育活动干预。在基线时间（第 0 天-T0）和第 90 天（T90）补充后收集人体测量学测量、问卷回答数据和采集血液进行代谢、炎症和激素测试。
结果
我们的结果表明，补充剂降低了体重指数（BMI）、腰高比（WHtR）、腰围、AST/ALT 比值、碱性磷酸酶和 HbA1c。补充后，IL-6 和 IL-10 水平以及睡眠、情绪和生活质量评分均有所改善。睡眠质量的改善似乎可以预测肥胖相关身体指标的降低。
结论
总之，营养补充剂可能与 90 天后的人体测量、代谢和内分泌参数有关，反映了幽默、睡眠和生活质量的提高。然而，需要认识到所呈现数据的局限性，因为这是一项初步研究。
临床试验注册
ClinicalTrials.gov，标识符 NCT04810572，于 2021 年 2 月 20 日注册。
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