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开发一款用于监测水解软骨基质补充剂对关节不适疗效的移动应用程序:真实世界研究。

Development of a Mobile App to Monitor the Effectiveness of a Hydrolyzed Cartilage Matrix Supplement on Joint Discomfort: Real-World Study.

作者信息

Newman Christie, Adriaens Els, Virgilio Nicolina, Vleminckx Sara, de Pelsmaeker Sara, Prawitt Janne, F Silva Catarina I

机构信息

Elénzia Ltd, Redditch, United Kingdom.

Adriaens Consulting, Aalter, Belgium.

出版信息

JMIR Form Res. 2023 Apr 3;7:e42967. doi: 10.2196/42967.

Abstract

BACKGROUND

Joint discomfort is a widespread and growing problem in active adults. The rising interest in preventative nutrition has increased the demand for supplements reducing joint discomfort. Protocols assessing the effect of a nutritional intervention on health commonly involve a series of face-to-face meetings between participants and study staff that can weigh on resources, participant availabilities, and even increase dropout rates. Digital tools are increasingly added to protocols to facilitate study conduct, but fully digitally run studies are still scarce. With the increasing interest in real-world studies, the development of health apps for mobile devices to monitor study outcomes is of great importance.

OBJECTIVE

The purpose of this real-world study was to develop a specific mobile app, Ingredients for Life, to conduct a 100% digital study testing the effectiveness of a hydrolyzed cartilage matrix (HCM) supplement on joint discomfort in a heterogeneous group of healthy, active consumers.

METHODS

The Ingredients for Life mobile app using a visual analog scale was specifically developed to monitor the variation in joint pain after exercise by the study participants. A total of 201 healthy and physically active women and men (18-72 years old) with joint pain completed the study over a period of 16 weeks. Participants were randomly allocated to the study groups and did not receive any dietary or lifestyle advice. Each participant indicated one area of joint pain and logged the type and duration of their weekly activities. They received blinded study supplements and took a daily regimen of 1 g of HCM (HCM group) or 1 g of maltodextrin (placebo group) for 12 weeks while weekly logging joint pain scores in the app. This was followed by a 4-week washout period during which participants continued reporting their joint pain scores (until the end of week 16).

RESULTS

Joint pain was reduced within 3 weeks of taking a low dosage of HCM (1 g/day), regardless of gender, age group, and activity intensity when compared with the placebo group. After stopping supplementation, joint pain scores gradually increased but still remained significantly lower than those of the placebo group after 4 weeks of washout. The low dropout rate (<6% of participants, mainly in the placebo group) demonstrates that the digital study was well received by the study population.

CONCLUSIONS

The digital tool allowed us to measure a heterogeneous group of active adults in a real-world setting (without any lifestyle intervention), thus promoting inclusivity and diversity. With low dropout rates, it demonstrates that mobile apps can generate qualitative, quantifiable, real-world data showcasing supplement effectiveness. The study confirmed that the oral intake of a low dose (1 g/day) of HCM led to a significant reduction of joint pain from 3 weeks after starting supplementation.

摘要

背景

关节不适在活跃的成年人中是一个普遍且日益严重的问题。对预防性营养的兴趣日益浓厚,增加了对减轻关节不适补充剂的需求。评估营养干预对健康影响的方案通常涉及参与者与研究人员之间的一系列面对面会议,这可能会消耗资源、影响参与者的可及性,甚至增加退出率。数字工具越来越多地被添加到方案中以促进研究开展,但完全数字化运行的研究仍然很少。随着对真实世界研究的兴趣增加,开发用于移动设备的健康应用程序以监测研究结果非常重要。

目的

这项真实世界研究的目的是开发一款名为“生命要素”的特定移动应用程序,以进行一项100%数字化研究,测试水解软骨基质(HCM)补充剂对一组异质性健康、活跃消费者关节不适的有效性。

方法

专门开发了使用视觉模拟量表的“生命要素”移动应用程序,以监测研究参与者运动后关节疼痛的变化。共有201名有关节疼痛的健康且身体活跃的女性和男性(18 - 72岁)在16周内完成了该研究。参与者被随机分配到研究组,且未接受任何饮食或生活方式建议。每位参与者指出一个关节疼痛区域,并记录其每周活动的类型和持续时间。他们收到盲法研究补充剂,并在12周内每天服用1克HCM(HCM组)或1克麦芽糊精(安慰剂组),同时每周在应用程序中记录关节疼痛评分。之后是4周的洗脱期,在此期间参与者继续报告他们的关节疼痛评分(直到第16周结束)。

结果

与安慰剂组相比,服用低剂量HCM(1克/天)3周内关节疼痛减轻,无论性别、年龄组和活动强度如何。停止补充后,关节疼痛评分逐渐增加,但在4周洗脱期后仍显著低于安慰剂组。低退出率(<6%的参与者,主要在安慰剂组)表明该数字化研究受到研究人群的欢迎。

结论

该数字工具使我们能够在真实世界环境中测量一组异质性活跃成年人(无需任何生活方式干预),从而促进包容性和多样性。由于退出率低,表明移动应用程序可以生成定性、可量化的真实世界数据以展示补充剂的有效性。该研究证实,口服低剂量(1克/天)HCM从开始补充3周后可显著减轻关节疼痛。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/685f/10131938/340767ca6106/formative_v7i1e42967_fig1.jpg

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