Ice Plant (Mesembryanthemum Crystallinum) Extract in Patients With Impaired Fasting Glucose

Last updated: January 17, 2024
Sponsor: Pusan National University Yangsan Hospital
Overall Status: Completed

Phase

N/A

Condition

Diabetes (Pediatric)

Treatment

Ice plant group

Placebo group

Clinical Study ID

NCT05544825
02-2022-016
  • Ages 19-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Those with fasting blood glucose of 100 mg/dL or more and less than 140 mg/dL

Exclusion

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 bloodglucose-lowering drugs or anti-obesity drugs, within 3 months
  • A person who has continuously taken health functional food that can affect bloodglucose within 1 month or health functional food can affect the interpretation of theresults 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.) withinthe last 6 months), heart disease (angina pectoris, myocardial infarction, heartfailure, arrhythmia that needs to be treated), or a malignant tumor (however, subjectswith a history of cerebrovascular disease or heart disease but clinically stable arenot 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 renalfailure, 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 canparticipate)
  • Those with HbAc1 of 7.0% or higher
  • Abnormal liver or renal function (more than twice the normal upper limit of theresearch institute)
  • Those who are currently being treated for thyroid disease
  • Those who have a history of gastrointestinal disease (eg, Crohn's disease) orgastrointestinal surgery (except simple appendectomy or hernia surgery) that mayaffect the absorption of the test food
  • Those who have participated or plan to participate in other drug clinical trialswithin the last 1 month
  • Persons taking drugs for psychiatric disorders (except for cases of intermittentmedication due to sleep disturbance)
  • Persons with alcoholism, drug abuse, or dependence
  • Pregnant or lactating or during this human application test period Women who plan tobecome pregnant during pregnancy
  • Those who have a clinically significant history or allergic reaction to drugs or foodfor human application
  • Appropriate methods of contraception among women of childbearing age (condoms,diaphragms, intrauterine contraceptives, male partner Women who do not accept theprocedure (if they have undergone resection) (however, women who have undergonesterilization are excluded)

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Ice plant group
Phase:
Study Start date:
July 01, 2022
Estimated Completion Date:
October 31, 2023

Study 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.

Connect with a study center

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeungsangnam-do 50612
    Korea, Republic of

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.