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

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.

Study Overview

• Status: Completed
• Conditions: Impaired Glucose Tolerance; Impaired Fasting Glucose; Normal
• Intervention / Treatment: Dietary supplement: Chitosan Oligosaccharide (GO2KA1); Dietary supplement: White egg

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chitosan Oligosaccharide (GO2KA1); Chitosan Oligosaccharide (GO2KA1) capsule was provided to the study participants. The Chitosan Oligosaccharide (GO2KA1) capsule was consumed within 15 min, and then 2-h oral sucrose tolerance test was conducted. The Chitosan Oligosaccharide (GO2KA1) one capsule had Chitosan Oligosaccharide 250mg.	Dietary supplement: Chitosan Oligosaccharide (GO2KA1); Chitosan Oligosaccharide (GO2KA1) capsule was consumed within 15 min, and then 2-h oral sucrose tolerance test was conducted.
Placebo Comparator: White egg; White egg capsule was provided to the study participants. The White egg capsule was consumed within 15 min, and then 2-h oral sucrose tolerance test was conducted. The Chitosan Oligosaccharide (GO2KA1) one capsule had White egg 250mg.	Dietary supplement: White egg; White egg capsule was consumed within 15 min, and then 2-h oral sucrose tolerance test was conducted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose levels	Glucose level differences during the 2-hr oral sucrose tolerance test between White egg and chitosan oligosaccharide (GO2KA1) intak	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• Jeong S, Min Cho J, Kwon YI, Kim SC, Yeob Shin D, Ho Lee J. Chitosan oligosaccharide (GO2KA1) improves postprandial glycemic response in subjects with impaired glucose tolerance and impaired fasting glucose and in healthy subjects: a crossover, randomized controlled trial. Nutr Diabetes. 2019 Nov 4;9(1):31. doi: 10.1038/s41387-019-0099-4.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2018
• Primary Completion (Actual): July 25, 2018
• Study Completion (Actual): July 25, 2018

Study Registration Dates

• First Submitted: August 26, 2018
• First Submitted That Met QC Criteria: August 26, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: August 26, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: blood glucose; diabetes mellitus; impaired fasting glucose; Impaired Glucose Tolerance; Chitosan Oligosaccharide; fasting blood sugar; normal blood glucose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hemostatics; Coagulants; Chelating Agents; Sequestering Agents; Chitosan
• Other Study ID Numbers: RCK_OFTT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No