Ice Plant (Mesembryanthemum Crystallinum) Extract in Patients With Impaired Fasting Glucose
NCT ID: NCT05544825
Last Updated: 2024-01-18
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
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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-07-01
2023-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ice plant group
This group takes ice plant extract for 12 weeks.
Ice plant group
Ice plant extract 2,000 mg/day for 12 weeks
Placebo group
This group takes a placebo for 12 weeks.
Placebo group
Placebo 2,000 mg/day for 12 weeks
Interventions
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Ice plant group
Ice plant extract 2,000 mg/day for 12 weeks
Placebo group
Placebo 2,000 mg/day for 12 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Those who have continuously taken drugs that may affect blood glucose, such as blood glucose-lowering drugs or anti-obesity drugs, within 3 months
* A person who has continuously taken health functional food that can affect blood glucose within 1 month or health functional food can affect the interpretation of the results of this study
* Those who took systemic steroids within 1 month
* Those who lost 0% or more in weight within the last 3 months
* Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.) within the last 6 months), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia that needs to be treated), or a malignant tumor (however, subjects with a history of cerebrovascular disease or heart disease but clinically stable are not eligible for the study at the discretion of the investigator.
* Persons with local or systemic inflammatory diseases
* Persons with renal disease such as hereditary hyperlipidemia, acute/chronic renal failure, nephrotic syndrome
* Persons with systolic blood pressure (BP) 160mmHg or diastolic BP 100mmHg or higher (provided that, those who are stably controlling their BP through drug treatment can participate)
* Those with HbAc1 of 7.0% or higher
* Abnormal liver or renal function (more than twice the normal upper limit of the research institute)
* Those who are currently being treated for thyroid disease
* Those who have a history of gastrointestinal disease (eg, Crohn's disease) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of the test food
* Those who have participated or plan to participate in other drug clinical trials within the last 1 month
* Persons taking drugs for psychiatric disorders (except for cases of intermittent medication due to sleep disturbance)
* Persons with alcoholism, drug abuse, or dependence
* Pregnant or lactating or during this human application test period Women who plan to become pregnant during pregnancy
* Those who have a clinically significant history or allergic reaction to drugs or food for human application
* Appropriate methods of contraception among women of childbearing age (condoms, diaphragms, intrauterine contraceptives, male partner Women who do not accept the procedure (if they have undergone resection) (however, women who have undergone sterilization are excluded)
19 Years
85 Years
ALL
Yes
Sponsors
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Pusan National University Yangsan Hospital
OTHER
Responsible Party
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Sang Yeoup Lee
Professor
Principal Investigators
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Sang Yeoup Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Yangsan Hospital
Locations
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Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, South Korea
Countries
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Other Identifiers
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02-2022-016
Identifier Type: -
Identifier Source: org_study_id
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