Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
95 participants
INTERVENTIONAL
2009-01-10
2009-06-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
control group
During the 12-week study period, the participants consumed two bottles (2 \*200 mL) of the experimental beverage (0g NnEx) per day with or after meals.
Nelumbo nucifera Leaf Extract
Hot water extracted Nelumbo nucifera Leaf, mainly containing quercetin and quercetin 3-O-glucuronide.
low concentration of NnEx group
During the 12-week study period, the participants consumed two bottles (2 \*200 mL) of the experimental beverage (1g NnEx) per day with or after meals.
Nelumbo nucifera Leaf Extract
Hot water extracted Nelumbo nucifera Leaf, mainly containing quercetin and quercetin 3-O-glucuronide.
high concentration of NnEx group
During the 12-week study period, the participants consumed two bottles (2 \*200 mL) of the experimental beverage (2g NnEx) per day with or after meals.
Nelumbo nucifera Leaf Extract
Hot water extracted Nelumbo nucifera Leaf, mainly containing quercetin and quercetin 3-O-glucuronide.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nelumbo nucifera Leaf Extract
Hot water extracted Nelumbo nucifera Leaf, mainly containing quercetin and quercetin 3-O-glucuronide.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Has no history of using any antidiabetic medication
* Absence of liver, kidney, or heart disease
* Absence of food allergy and daily tea consumption \<2 L
* Meet all of the above criteria and to follow the instructions given during the study.
Exclusion Criteria
* Difficulty attending the hospital on the required days
* Lack of data regarding the times of beverage consumption for over 5% of the study
* Abnormal overeating
* Test results believed to be unreliable because of the lack of provision of diet and exercise reports during the fasting period
* Difficulty drawing blood
* Poor confidence in the test data
40 Years
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Meiji Health Science and Technology Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zai-Si Ji, phD
Principal Investigator
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ShanghaiMHST
Identifier Type: -
Identifier Source: org_study_id