Impaired Fasting GlucoseNCT05544825
Ice Plant (Mesembryanthemum Crystallinum) Extract in Patients With Impaired Fasting Glucose
A study testing Ice plant group in people with Impaired Fasting Glucose, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Fasting Glucose
- What is being tested?
- Ice plant group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those with fasting blood glucose of 100 mg/dL or more and less than 140 mg/dL
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, 50612
About this study
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
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.
Read the 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.
- Conditions
- Impaired Fasting Glucose
- Being tested
- Ice plant group, Placebo group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice plant groupDietary supplement
Ice plant extract 2,000 mg/day for 12 weeks
Placebo groupDietary supplement
Placebo 2,000 mg/day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ice plant group | Experimental | This group takes ice plant extract for 12 weeks. Receives: Dietary Supplement: Ice plant group |
| Placebo group | Placebo comparator | This group takes a placebo for 12 weeks. Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
75-g Oral Glucose Tolerance Test (120 minute glucose)
mg/dL
Measured: 12 weeks
Secondary outcomes (10)
Incremental Area Under the Curve 0-120 minutes
mg/dL
Measured: 12 weeks
75-g Oral Glucose Tolerance Test (0, 30, 60, 90 minute glucose)
mg/dL
Measured: 12 weeks
Fasting Insulin
µU/ml
Measured: 12 weeks
Homeostasis Model Assessment for Insulin Resistance
fasting insulin (µU/ml) + fasting glucose (mg/dl)/405
Measured: 12 weeks
Quantitative Insulin Sensitivity Check Index
1/(log(fasting insulin µU/ml) + log(fasting glucose mg/dl))
Measured: 12 weeks
HbA1c
percentage
Measured: 12 weeks
Total cholesterol
mg/dL
Measured: 12 weeks
Triglyceride
mg/dL
Measured: 12 weeks
Low-density lipoprotein cholesterol
mg/dL
Measured: 12 weeks
High-density lipoprotein cholesterol
mg/dL
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Jul 2022
- Primary completion30 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Fasting GlucoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544825
- Sponsor's protocol ID
- 02-2022-016
- Status last verified
- Jan 2024
- First submitted
- 14 Sep 2022
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05544825
- Acronym / sponsor ID
- 02-2022-016
- Conditions
- Impaired Fasting Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ice plant group | Experimental | Dietary Supplement: Ice plant groupThis group takes ice plant extract for 12 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupThis group takes a placebo for 12 weeks. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Those with fasting blood glucose of 100 mg/dL or more and less than 140 mg/dL
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ice plant groupIce plant extract 2,000 mg/day for 12 weeks | Dietary supplement | Ice plant group |
| Placebo groupPlacebo 2,000 mg/day for 12 weeks | Dietary supplement | Placebo group |
Primary outcome
75-g Oral Glucose Tolerance Test (120 minute glucose)
Time frame: 12 weeks
mg/dL
10 secondary outcomes
Incremental Area Under the Curve 0-120 minutes
Time frame: 12 weeks
75-g Oral Glucose Tolerance Test (0, 30, 60, 90 minute glucose)
Time frame: 12 weeks
Fasting Insulin
Time frame: 12 weeks
Homeostasis Model Assessment for Insulin Resistance
Time frame: 12 weeks
Quantitative Insulin Sensitivity Check Index
Time frame: 12 weeks
HbA1c
Time frame: 12 weeks
Total cholesterol
Time frame: 12 weeks
Triglyceride
Time frame: 12 weeks
Low-density lipoprotein cholesterol
Time frame: 12 weeks
High-density lipoprotein cholesterol
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Yeoup Lee, MD, PhD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ice plant group in people with Impaired Fasting Glucose, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
75-g Oral Glucose Tolerance Test (120 minute glucose) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.