Ice Plant (Mesembryanthemum Crystallinum) Extract in Patients With Impaired Fasting Glucose
Primary Purpose
Impaired Fasting Glucose
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ice plant group
Placebo group
Sponsored by
About this trial
This is an interventional treatment trial for Impaired Fasting Glucose
Eligibility Criteria
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)
Sites / Locations
- Pusan National University Yangsan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ice plant group
Placebo group
Arm Description
This group takes ice plant extract for 12 weeks.
This group takes a placebo for 12 weeks.
Outcomes
Primary Outcome Measures
75-g Oral Glucose Tolerance Test (120 minute glucose)
mg/dL
Secondary Outcome Measures
Incremental Area Under the Curve 0-120 minutes
mg/dL
75-g Oral Glucose Tolerance Test (0, 30, 60, 90 minute glucose)
mg/dL
Fasting Insulin
µU/ml
Homeostasis Model Assessment for Insulin Resistance
fasting insulin (µU/ml) + fasting glucose (mg/dl)/405
Quantitative Insulin Sensitivity Check Index
1/(log(fasting insulin µU/ml) + log(fasting glucose mg/dl))
HbA1c
percentage
Total cholesterol
mg/dL
Triglyceride
mg/dL
Low-density lipoprotein cholesterol
mg/dL
High-density lipoprotein cholesterol
mg/dL
Full Information
NCT ID
NCT05544825
First Posted
September 14, 2022
Last Updated
October 20, 2023
Sponsor
Pusan National University Yangsan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05544825
Brief Title
Ice Plant (Mesembryanthemum Crystallinum) Extract in Patients With Impaired Fasting Glucose
Official Title
Evaluation of Efficacy and Safety of Ice Plant (Mesembryanthemum Crystallinum) Extract in Patients With Impaired Fasting Glucose: a Double-blind, Randomized, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Fasting Glucose
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ice plant group
Arm Type
Experimental
Arm Description
This group takes ice plant extract for 12 weeks.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This group takes a placebo for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ice plant group
Intervention Description
Ice plant extract 2,000 mg/day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo group
Intervention Description
Placebo 2,000 mg/day for 12 weeks
Primary Outcome Measure Information:
Title
75-g Oral Glucose Tolerance Test (120 minute glucose)
Description
mg/dL
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Incremental Area Under the Curve 0-120 minutes
Description
mg/dL
Time Frame
12 weeks
Title
75-g Oral Glucose Tolerance Test (0, 30, 60, 90 minute glucose)
Description
mg/dL
Time Frame
12 weeks
Title
Fasting Insulin
Description
µU/ml
Time Frame
12 weeks
Title
Homeostasis Model Assessment for Insulin Resistance
Description
fasting insulin (µU/ml) + fasting glucose (mg/dl)/405
Time Frame
12 weeks
Title
Quantitative Insulin Sensitivity Check Index
Description
1/(log(fasting insulin µU/ml) + log(fasting glucose mg/dl))
Time Frame
12 weeks
Title
HbA1c
Description
percentage
Time Frame
12 weeks
Title
Total cholesterol
Description
mg/dL
Time Frame
12 weeks
Title
Triglyceride
Description
mg/dL
Time Frame
12 weeks
Title
Low-density lipoprotein cholesterol
Description
mg/dL
Time Frame
12 weeks
Title
High-density lipoprotein cholesterol
Description
mg/dL
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Yeoup Lee, MD, PhD
Phone
01091345959
Ext
055
Email
saylee@pnu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Li Lee
Phone
360-2860
Ext
055
Email
yeri1230@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD, PhD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeungsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD
Phone
360-1442
Ext
055
Email
saylee@pnu.edu
First Name & Middle Initial & Last Name & Degree
Ye Li Lee
Phone
360-2860
Ext
055
Email
saylee@pnu.edu
12. IPD Sharing Statement
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Ice Plant (Mesembryanthemum Crystallinum) Extract in Patients With Impaired Fasting Glucose
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