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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03650023
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 14.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Normal; Impaired Fasting Glucose; Impaired Glucose Tolerance	Dietary Supplement: Chitosan Oligosaccharide (GO2KA1); Dietary Supplement: White egg	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 9, 2018
• Actual Primary Completion Date: Jul 25, 2018
• Actual Study Completion Date: Jul 25, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Glucose levels [2 hours]

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

Secondary Outcome Measures

1. The areas under the curve (AUC) of glucose [1 day of second visit (after finishing cross-over trial)]

   Glucose AUC differences between White egg and chitosan oligosaccharide (GO2KA1) intake

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jong Ho Lee, Professor, PI, Yonsei University
• ClinicalTrials.gov Identifier: NCT03650023
• Other Study ID Numbers: RCK_OFTT
• First Posted: Aug 28, 2018
• Last Update Posted: Aug 28, 2018
• Last Verified: Aug 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jong Ho Lee, Professor, PI, Yonsei University: Chitosan Oligosaccharide; diabetes mellitus; blood glucose; fasting blood sugar; normal blood glucose; impaired fasting glucose; Impaired Glucose Tolerance
• Additional relevant MeSH terms: Glucose Intolerance; Chitosan

Study Results

No Results Posted as of Aug 28, 2018