Evidence map›Paper›PMID 41239421›Full record

ArticleTrials2025

Effects of Jinhua instant dark tea in patients with type 2 diabetes mellitus: study protocol for a multicenter, open-label, randomized controlled trial.

Ningsu Chen, Kai Zhao, Ye Xu, Yana Qi, Daomei Cheng, Mengnan Zhao, Dejiao Meng, Lei Shi, Jiajie Yu

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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3 · Its place in the literature

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0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Ningsu Chen *Department of Clinical Nutrition, West China Hospital, Sichuan University, Chengdu, China.
Kai Zhao *Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, China.
Ye XuChadianzi Health Service Center in Jinniu District, Chengdu, China.
Yana QiChinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, China.
Daomei ChengChengdu Medical College, Chengdu, China.
Mengnan ZhaoChinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, China.
Dejiao MengThe First Affiliated Hospital of Chengdu Medical College, Chengdu, China.
Lei ShiDepartment of Clinical Nutrition, West China Hospital, Sichuan University, Chengdu, China. shileiaini_123@163.com.
Jiajie YuDepartment of Clinical Nutrition, West China Hospital, Sichuan University, Chengdu, China. yujiajie@wchscu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundsThe global prevalence of diabetes is rising, with many patients experiencing challenges in medication adherence and adverse effects associated with synthetic drugs. Natural products have attracted interest as potential preventive or adjunctive therapies. Jinhua dark tea (JHTea), a naturally fermented Chinese tea, has shown promising glucose-lowering and lipid-modulating effects in vitro and animal studies, but robust clinical evidence is lacking. This study is the first large-scale, long-term randomized controlled trial (RCT) evaluating JHTea as an adjunctive therapy for type 2 diabetes mellitus (T2DM).

methodsThis multicenter, open-label parallel randomized controlled trial across three centers in China will enroll 264 participants aged 40-70 years with T2DM, excluding those with gastrointestinal diseases or acute diabetes-related complications. Participants will be randomized 1:1 to the following: (1) intervention Group: 1 g of JHTea three times daily plus current oral hypoglycemic agents for 12 months. (2) control Group: warm water plus current oral hypoglycemic agents alone, with no extra active intervention. The primary outcome is the change in hemoglobin A1c (HbA1c) at 6 months. Secondary outcomes at 6 and 12 months include diabetes remission rate, fasting plasma glucose (FPG), 2-h postprandial glucose, triglyceride-glucose index (TyG), blood pressure, abdominal circumference, body mass index (BMI), and other metabolic parameters. DISCUSSION: This study aims to investigate the glycemic and lipid-modulating effects of Jinhua instant dark tea in patients with T2DM. The findings may support the adjunctive role of fermented Jinhua tea in diabetes management, providing a complementary strategy to conventional therapies.

trial registrationChinese Clinical Trial Registry ChiCTR2400080339. Registered on 26 January 2024. https://www.chictr.org.cn/showproj.html?proj=214179.

Indexed as

Diabetes Mellitus, Type 2Hypoglycemic AgentsTeaAdultAgedBiomarkersBlood GlucoseChinaFemaleGlycated HemoglobinGlycemic ControlHumansMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicBiomarkersBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsTeaJinhua instant dark teaRandomized controlled trialType 2 diabetes

Identifiers

PMID41239421
PMCPMC12619345

What Socratic holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.