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烟酰胺核糖和白藜芦醇可降低非酒精性脂肪性肝病的肝炎症标志物:一项双盲、安慰剂对照临床试验。

Nicotinamide riboside and pterostilbene reduces markers of hepatic inflammation in NAFLD: A double-blind, placebo-controlled clinical trial.

机构信息

Elysium Health New York , New York , New York , USA.

Nutrasource , Guelph , Ontario , Canada.

出版信息

Hepatology. 2023 Sep 1;78(3):863-877. doi: 10.1002/hep.32778. Epub 2022 Nov 22.

Abstract

BACKGROUND AND AIMS

The prevalence of NAFLD is increasing globally and on a path to becoming the most frequent cause of chronic liver disease. Strategies for the prevention and treatment of NAFLD are urgently needed.

APPROACH AND RESULTS

A 6-month prospective, randomized, double-blind, placebo-controlled clinical trial was conducted to assess the efficacy of daily NRPT (commercially known as Basis, a combination of nicotinamide riboside and pterostilbene) supplementation in 111 adults with NAFLD. The study consisted of three arms: placebo, recommended daily dose of NRPT (NRPT 1×), and a double dose of NRPT (NRPT 2×). NRPT appeared safe and well tolerated. At the end of the study, no significant change was seen in the primary endpoint of hepatic fat fraction with respect to placebo. However, among prespecified secondary outcomes, a time-dependent decrease in the circulating levels of the liver enzymes alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) was observed in the NRPT 1× group, and this decrease was significant with respect to placebo. Furthermore, a significant decrease in the circulating levels of the toxic lipid ceramide 14:0 was also observed in the NRPT 1× group versus placebo, and this decrease was associated with a decrease in ALT in individuals of this group. A dose-dependent effect was not observed with respect to ALT, GGT, or ceramide 14:0 in the NRPT 2× group.

CONCLUSIONS

This study demonstrates that NRPT at the recommended dose is safe and may hold promise in lowering markers of hepatic inflammation in patients with NAFLD.

摘要

背景和目的

非酒精性脂肪性肝病(NAFLD)的患病率在全球范围内呈上升趋势,并有可能成为慢性肝病最常见的病因。因此,迫切需要制定预防和治疗 NAFLD 的策略。

方法和结果

我们进行了一项为期 6 个月的前瞻性、随机、双盲、安慰剂对照临床试验,以评估每日 NRPT(商品名为 Basis,烟酰胺核糖和白藜芦醇的组合)补充剂在 111 例 NAFLD 成人患者中的疗效。该研究包括 3 个组:安慰剂组、推荐剂量的 NRPT 组(NRPT 1×)和双倍剂量的 NRPT 组(NRPT 2×)。NRPT 似乎安全且耐受良好。在研究结束时,与安慰剂相比,主要终点肝脏脂肪分数没有显著变化。然而,在预先指定的次要终点中,NRPT 1×组观察到循环丙氨酸氨基转移酶(ALT)和γ-谷氨酰转移酶(GGT)水平呈时间依赖性下降,与安慰剂相比,这种下降具有显著意义。此外,NRPT 1×组还观察到循环神经酰胺 14:0 的毒性脂质水平显著下降,与该组 ALT 下降相关。NRPT 2×组在 ALT、GGT 或神经酰胺 14:0 方面未观察到剂量依赖性效应。

结论

本研究表明,推荐剂量的 NRPT 安全且可能有希望降低 NAFLD 患者的肝脏炎症标志物。

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