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健康成年人中软糖型和胶囊型维生素C的生物等效性:一项随机对照试验。

Vitamin C Bioequivalence from Gummy and Caplet Sources in Healthy Adults: A Randomized-Controlled Trial.

作者信息

Evans Malkanthi, Guthrie Najla, Zhang H Kelly, Hooper William, Wong Andrew, Ghassemi Annahita

机构信息

KGK Science Inc, London, Ontario, Canada.

Church & Dwight Co., Inc, Ewing, New Jersey, USA.

出版信息

J Am Coll Nutr. 2020 Jul;39(5):422-431. doi: 10.1080/07315724.2019.1684398. Epub 2019 Nov 20.

Abstract

The efficacy of Vitamin C (L-ascorbic acid) supplementation can be assessed by uptake into the blood and retention in leukocytes. Vitafusion® Power C gummy is an alternative vitamin C source which may exhibit similar bioavailability to comparator caplets. The objective of this study was to evaluate the bioequivalence of vitamin C from a vitafusion® Power C gummy formulation and a comparator caplet in healthy adults. Thirty healthy men and women, 34.0 ± 11.4 years of age and Body Mass Index (BMI) 24.5 ± 3.6 kg/m completed the randomized examiner-blind, comparator controlled, cross-over trial with two sequences: gummy (1000 mg) to caplet (1000 mg) or caplet to gummy. Intake of foods fortified with Vitamin C was restricted 7 days prior to each dosing. Blood samples were collected pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 h post-dose for plasma and leukocytes; and urine was collected pre-dose and between 0-2, 2-4, 4-8, 8-12 and 12-24 h post-dose for L-ascorbic acid analysis. Vitafusion® Power C gummy and comparator caplet demonstrated similar plasma absorption profiles as there were no significant differences in plasma L-ascorbic acid total Area Under the Curve (AUC), and T between gummy and caplet. The caplet did elicit a significantly higher C than the gummy ( < 0.05), however, the difference was numerically small. Leukocyte L-ascorbic acid total AUC and C were not significantly different between gummy and caplet, however T of the gummy group was significantly longer ( = 0.012). Urinary L-ascorbic acid levels were also not significantly different between gummy and caplet. There were no serious adverse events and safety parameters remained within normal clinical range for both products. Vitafusion® Power C gummy exhibited similar Vitamin C absorption and bioavailability to a comparator caplet in healthy adults and were considered bioequivalent.

摘要

补充维生素C(L-抗坏血酸)的功效可通过其在血液中的摄取量和在白细胞中的留存量来评估。维塔富新®强力C咀嚼软糖是一种替代维生素C来源,其生物利用度可能与对照胶囊相似。本研究的目的是评估维塔富新®强力C咀嚼软糖配方中的维生素C与对照胶囊在健康成年人中的生物等效性。30名健康男性和女性,年龄34.0±11.4岁,体重指数(BMI)24.5±3.6kg/m²,完成了随机、研究者盲法、对照、交叉试验,试验分两个序列:软糖(1000mg)到胶囊(1000mg)或胶囊到软糖。每次给药前7天限制摄入富含维生素C的食物。在给药前以及给药后0.5、1、2、3、4、5、6、8、10、12和24小时采集血样用于血浆和白细胞检测;给药前以及给药后0-2、2-4、4-8、8-12和12-24小时收集尿液用于L-抗坏血酸分析。维塔富新®强力C咀嚼软糖和对照胶囊的血浆吸收曲线相似,因为软糖和胶囊之间血浆L-抗坏血酸的总曲线下面积(AUC)和达峰时间(Tmax)没有显著差异。胶囊的峰浓度(Cmax)确实比软糖显著更高(P<0.05),然而,数值差异较小。软糖和胶囊之间白细胞L-抗坏血酸的总AUC和Cmax没有显著差异,然而软糖组的达峰时间(Tmax)显著更长(P=0.012)。软糖和胶囊之间的尿L-抗坏血酸水平也没有显著差异。两种产品均未出现严重不良事件,安全参数均保持在正常临床范围内。维塔富新®强力C咀嚼软糖在健康成年人中表现出与对照胶囊相似的维生素C吸收和生物利用度,被认为具有生物等效性。

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