NCT05544825

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

Evaluation of Efficacy and Safety of Ice Plant (Mesembryanthemum Crystallinum) Extract in Patients With Impaired Fasting Glucose: a Double-blind, Randomized, Placebo-controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Pusan National University Yangsan Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Impaired Fasting Glucose

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ice plant group	Ice plant extract 2,000 mg/day for 12 weeks
DIETARY_SUPPLEMENT	Placebo group	Placebo 2,000 mg/day for 12 weeks

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-10-30
• Completion: 2023-10-31
• First posted: 2022-09-16
• Last updated: 2024-01-18

Locations

1 site across 1 country: South Korea