Protocol for a randomized controlled trial to evaluate the impact of daily supplementation with zinc, chromium, vitamin C, and copper on progression of prediabetes in Jakarta, Indonesia

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-07-11 DOI:10.1016/j.cct.2025.108007

Rina Agustina , Erfi Prafiantini , Alfi R. Putri , Rachmi Mufida , Hanifa Hanifa , Shofura Afifah , Dicky L. Tahapary , Anuraj H. Shankar , Pradana Soewondo

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Abstract

The increase in prediabetes globally presents a major public health concern as individuals with prediabetes are at a higher risk of developing type 2 diabetes, highlighting the need for effective interventions. We present an intervention study protocol to evaluate the effects of daily supplementation with zinc, chromium, vitamin C, and copper (ZCC), combined with standard lifestyle interventions, on glucose profiles in prediabetic adults. We will conduct a randomized, double-blind, placebo-controlled trial over 12 months involving 670 prediabetic adults aged 35 to 64 in urban neighborhoods of Jakarta, Indonesia, with access to primary health centers or hospitals providing outpatient services. Participants will be divided into two groups: one will receive daily ZCC tablets (30 mg zinc, 50 μg chromium, 500 mg vitamin C, and 1 mg copper) alongside lifestyle interventions, while the other will receive an identical placebo with the same lifestyle intervention. Primary outcomes will include fasting blood glucose, a 2-h oral glucose tolerance test, hemoglobin A1c, and HOMA-IR levels, as well as the proportion of participants progressing to diabetes or becoming normal. Secondary outcomes will focus on lifestyle changes, lipid profiles, body weight and composition, and safety. Follow-up visits will be scheduled at 3, 6, and 12 months, with compliance monitored through returned tablet counts. This study aims to inform future nutritional interventions for diabetes prevention.

Trial registration

ClinicalTrials.gov ID NCT04511468. Registered on June 1st, 2020.

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一项评估每日补充锌、铬、维生素C和铜对印度尼西亚雅加达糖尿病前期进展影响的随机对照试验方案。

全球糖尿病前期患者的增加引起了一个重大的公共卫生问题，因为糖尿病前期患者患2型糖尿病的风险更高，因此需要采取有效的干预措施。我们提出了一项干预研究方案，以评估每日补充锌、铬、维生素C和铜（ZCC）并结合标准生活方式干预对糖尿病前期成人血糖谱的影响。我们将进行一项为期12个 月的随机、双盲、安慰剂对照试验，涉及670名年龄在35至64岁之间的糖尿病前期成年人，他们来自印度尼西亚雅加达的城市社区，可以进入初级卫生中心或提供门诊服务的医院。参与者将被分为两组：一组每天服用ZCC片（30 毫克锌，50 μg铬，500 毫克维生素C和1 毫克铜）并进行生活方式干预，而另一组服用相同的安慰剂并进行相同的生活方式干预。主要结局将包括空腹血糖、2小时口服葡萄糖耐量试验、血红蛋白A1c和HOMA-IR水平，以及参与者进展为糖尿病或恢复正常的比例。次要结果将集中在生活方式的改变、脂质谱、体重和成分以及安全性。随访将安排在3、6和12 个月，通过退回的药片数量监测依从性。本研究旨在为未来预防糖尿病的营养干预提供信息。试验注册：ClinicalTrials.gov编号NCT04511468。2020年6月1日注册。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.