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

Primary Purpose

Normal, Impaired Fasting Glucose, Impaired Glucose Tolerance

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Chitosan Oligosaccharide (GO2KA1)

White egg

About this trial

This is an interventional treatment trial for Normal focused on measuring Chitosan Oligosaccharide, diabetes mellitus, blood glucose, fasting blood sugar, normal blood glucose, impaired fasting glucose, Impaired Glucose Tolerance

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Chitosan Oligosaccharide (GO2KA1)

White egg

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Glucose levels

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

Secondary Outcome Measures

The areas under the curve (AUC) of glucose

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

Full Information

NCT ID

NCT03650023

First Posted

August 26, 2018

Last Updated

August 26, 2018

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03650023

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

May 9, 2018 (Actual)

Primary Completion Date

July 25, 2018 (Actual)

Study Completion Date

July 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Normal, Impaired Fasting Glucose, Impaired Glucose Tolerance

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chitosan Oligosaccharide (GO2KA1)

Arm Type

Experimental

Arm Description

Arm Title

White egg

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Chitosan Oligosaccharide (GO2KA1)

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

White egg

Intervention Description

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

Primary Outcome Measure Information:

Title

Glucose levels

Description

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

Time Frame

2 hours

Secondary Outcome Measure Information:

Title

The areas under the curve (AUC) of glucose

Description

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

Time Frame

1 day of second visit (after finishing cross-over trial)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

31685797

Citation

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.

Results Reference

derived

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

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