NCT05544825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

September 14, 2022

Last Update Submit

January 17, 2024

Conditions

Impaired Fasting Glucose

Outcome Measures

Primary Outcomes (1)

  • 75-g Oral Glucose Tolerance Test (120 minute glucose)

    mg/dL

    12 weeks

Secondary Outcomes (10)

  • Incremental Area Under the Curve 0-120 minutes

    12 weeks

  • 75-g Oral Glucose Tolerance Test (0, 30, 60, 90 minute glucose)

    12 weeks

  • Fasting Insulin

    12 weeks

  • Homeostasis Model Assessment for Insulin Resistance

    12 weeks

  • Quantitative Insulin Sensitivity Check Index

    12 weeks

  • +5 more secondary outcomes

Study Arms (2)

Ice plant group

EXPERIMENTAL

This group takes ice plant extract for 12 weeks.

Dietary Supplement: Ice plant group

Placebo group

PLACEBO COMPARATOR

This group takes a placebo for 12 weeks.

Dietary Supplement: Placebo group

Interventions

Ice plant groupDIETARY_SUPPLEMENT

Ice plant extract 2,000 mg/day for 12 weeks

Ice plant group
Placebo groupDIETARY_SUPPLEMENT

Placebo 2,000 mg/day for 12 weeks

Placebo group

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

Location

Study Officials

  • Sang Yeoup Lee, MD, PhD

    Pusan National University Yangsan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 16, 2022

Study Start

July 1, 2022

Primary Completion

October 30, 2023

Study Completion

October 31, 2023

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations

KR(1)