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

Impaired Glucose Tolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03650023
• Other study ID #: RCK_OFTT
• Status: Completed
• Phase: N/A
• Start date: May 9, 2018
• Est. completion date: July 25, 2018

Study information

• Verified date: August 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 25, 2018
• Est. primary completion date: July 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Fasting Glucose
• Impaired Glucose Tolerance
• Normal
• Prediabetic State

Intervention

Dietary Supplement:
• Chitosan Oligosaccharide (GO2KA1)
Chitosan Oligosaccharide (GO2KA1) capsule was consumed within 15 min, and then 2-h oral sucrose tolerance test was conducted.
• White egg
White egg capsule was consumed within 15 min, and then 2-h oral sucrose tolerance test was conducted.

Locations

Country	Name	City	State
Korea, Republic of	Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose levels	Glucose level differences during the 2-hr oral sucrose tolerance test between White egg and chitosan oligosaccharide (GO2KA1) intak	2 hours
Secondary	The areas under the curve (AUC) of glucose	Glucose AUC differences between White egg and chitosan oligosaccharide (GO2KA1) intake	1 day of second visit (after finishing cross-over trial)