- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05544825
Ice Plant (Mesembryanthemum Crystallinum) Extract in Patients With Impaired Fasting Glucose
January 17, 2024 updated by: Sang Yeoup Lee, Pusan National University Yangsan Hospital
Evaluation of Efficacy and Safety of Ice Plant (Mesembryanthemum Crystallinum) Extract in Patients With Impaired Fasting Glucose: a Double-blind, Randomized, Placebo-controlled Study
The investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects and tolerability of ice plant (Mesembryanthemum crystallinum) extract in patients with impaired fasting glucose for 12 weeks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A previous animal study has indicated that ice plant (Mesembryanthemum crystallinum) extract (IPE) has a substantial effect on attenuating hyperglycemia and modulating gut microbiota composition in diabetic rats.
Therefore, IPE might be a promising functional food for the prevention of diabetes.
Therefore, the investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects of IPE in patients with impaired fasting glucose for 12 weeks; the safety of the compound is also evaluated.
The Investigators examine 75-g oral glucose tolerance test (OGTT) (120 minute glucose), 75-g OGTT incremental Area Under the Curve 0-120min, 75-g OGTT (0, 30, 60, 90 minute glucose), fasting insulin, Homeostasis Model Assessment for Insulin Resistance, Quantitative Insulin Sensitivity Check Index, HbA1c, lipid profile (total cholesterol, triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol) at baseline and after 12 weeks of intervention.
One hundred adults were administered either 2,000 mg of IPE or a placebo each day for 12 weeks.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sang Yeoup Lee, MD, PhD
- Phone Number: 055 01091345959
- Email: saylee@pnu.edu
Study Contact Backup
- Name: Ye Li Lee
- Phone Number: 055 360-2860
- Email: yeri1230@gmail.com
Study Locations
-
-
Gyeungsangnam-do
-
Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
- Pusan National University Yangsan Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Those with fasting blood glucose of 100 mg/dL or more and less than 140 mg/dL
Exclusion Criteria:
- Those who have been diagnosed with type 1 or type 2 diabetes
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ice plant group
This group takes ice plant extract for 12 weeks.
|
Ice plant extract 2,000 mg/day for 12 weeks
|
Placebo Comparator: Placebo group
This group takes a placebo for 12 weeks.
|
Placebo 2,000 mg/day for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
75-g Oral Glucose Tolerance Test (120 minute glucose)
Time Frame: 12 weeks
|
mg/dL
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incremental Area Under the Curve 0-120 minutes
Time Frame: 12 weeks
|
mg/dL
|
12 weeks
|
75-g Oral Glucose Tolerance Test (0, 30, 60, 90 minute glucose)
Time Frame: 12 weeks
|
mg/dL
|
12 weeks
|
Fasting Insulin
Time Frame: 12 weeks
|
µU/ml
|
12 weeks
|
Homeostasis Model Assessment for Insulin Resistance
Time Frame: 12 weeks
|
fasting insulin (µU/ml) + fasting glucose (mg/dl)/405
|
12 weeks
|
Quantitative Insulin Sensitivity Check Index
Time Frame: 12 weeks
|
1/(log(fasting insulin µU/ml) + log(fasting glucose mg/dl))
|
12 weeks
|
HbA1c
Time Frame: 12 weeks
|
percentage
|
12 weeks
|
Total cholesterol
Time Frame: 12 weeks
|
mg/dL
|
12 weeks
|
Triglyceride
Time Frame: 12 weeks
|
mg/dL
|
12 weeks
|
Low-density lipoprotein cholesterol
Time Frame: 12 weeks
|
mg/dL
|
12 weeks
|
High-density lipoprotein cholesterol
Time Frame: 12 weeks
|
mg/dL
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sang Yeoup Lee, MD, PhD, Pusan National University Yangsan Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Actual)
October 30, 2023
Study Completion (Actual)
October 31, 2023
Study Registration Dates
First Submitted
September 14, 2022
First Submitted That Met QC Criteria
September 14, 2022
First Posted (Actual)
September 16, 2022
Study Record Updates
Last Update Posted (Estimated)
January 18, 2024
Last Update Submitted That Met QC Criteria
January 17, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-2022-016
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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