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A Crossover Trial of Chitosan Oligosaccharide on Post Prandial Glucose Control in Subjects With Normal, IFG and IGT

A Crossover Trial of Chitosan Oligosaccharide (GO2KA1) on Post Prandial Glucose Control in Subjects With Normal Blood Glucose, Impaired Fasting Glucose and Impaired Glucose Tolerance

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03650023
Enrollment
37
Registered
2018-08-28
Start date
2018-05-09
Completion date
2018-07-25
Last updated
2018-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaired Fasting Glucose, Impaired Glucose Tolerance, Normal

Keywords

Chitosan Oligosaccharide, diabetes mellitus, blood glucose, fasting blood sugar, normal blood glucose, impaired fasting glucose, Impaired Glucose Tolerance

Brief summary

It is well known that Chitosan oligosaccharide is low molecular weight and water soluble and chitosan oligosaccharide has been shown to reduce blood cholesterol and blood pressure, increase immunity, and enhance antitumor properties. the effect of chitosan oligosaccharide (GO2KA1) supplementation on glucose control in subjects with normal blood glucose, impaired fasting glucose and impaired glucose tolerance.

Detailed description

A randomized, double-blinded, controlled, cross-over trial was conducted to verify the effects of chitosan oligosaccharide (GO2KA1). forty healthy male and female subjects aged 20-75 years with normal blood glucose, impaired fasting glucose and impaired glucose tolerance were recruited. The subjects visited the research site twice over with a seven-day interval after an overnight fast at least 12 hr. On the screening visit, the participants were the 2-hr oral glucose tolerance test (OGTT) was conducted. And they were separated normal blood glucose, impaired fasting glucose and impaired glucose tolerance. On the first visit, the participants were randomly assigned to consume a test or placebo product \[test product: chitosan oligosaccharide powder 500mg (GO2KA1); placebo product: white egg powder 500mg\] and ingested the assigned product. On the second visit, the participants consumed the other product that they did not eat on the first visit. On both visit day, the 2-hr oral sucrose tolerance test (OSTT) was conducted and started at 8:00 in the morning; venous blood samples were collected before (0 hr) and after ingestion (0.5, 1 and 2 hr) of the products.

Interventions

DIETARY_SUPPLEMENTChitosan Oligosaccharide (GO2KA1)

Chitosan Oligosaccharide (GO2KA1) capsule was consumed within 15 min, and then 2-h oral sucrose tolerance test was conducted.

DIETARY_SUPPLEMENTWhite egg

White egg capsule was consumed within 15 min, and then 2-h oral sucrose tolerance test was conducted.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
Yes

Inclusion criteria

* Normal Blood Glucose (fasting blood sugar below 100mg/dl, two hours after meals below 140mg/dl) * Impaired Fasting Glucose (fasting blood sugar 100-125mg/dl) * Impaired Glucose Tolerance (two hours after meals 140-199mg/dl)

Exclusion criteria

* history/presence of diabetes mellitus (including oral hypoglycaemic agent and insulin) * history of serious hypoglycemia * history of serious cardiovascular, cerebrovascular disease, pulmonary, gastrointestinal, hepatic, renal and/or haematological disease * uncontrolled blood pressure (blood pressure level more than 140/90mmHg) * history/presence of alcoholism, drug addiction, etc. * taking a regulation of blood glucose medications within 1 month before study * participation other intervention studies within 1 months before study * history of diagnosed with cancer, cancer surgery and hospitalization * women who are pregnant or desire to become pregnant during the study period * having any other medical condition which, in the opinion of the investigator, could interfere with participation in the study

Design outcomes

Primary

MeasureTime frameDescription
Glucose levels2 hoursGlucose level differences during the 2-hr oral sucrose tolerance test between White egg and chitosan oligosaccharide (GO2KA1) intak

Secondary

MeasureTime frameDescription
The areas under the curve (AUC) of glucose1 day of second visit (after finishing cross-over trial)Glucose AUC differences between White egg and chitosan oligosaccharide (GO2KA1) intake

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026