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

NCT ID: NCT03650023

Last Updated: 2018-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-09
• Study Completion Date: 2018-07-25

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.

Conditions

Normal; Impaired Fasting Glucose; Impaired Glucose Tolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Chitosan Oligosaccharide (GO2KA1)

Intervention Type: DIETARY_SUPPLEMENT

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 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.

Group Type: PLACEBO_COMPARATOR

White egg

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Chitosan Oligosaccharide (GO2KA1)

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

Intervention Type: DIETARY_SUPPLEMENT

White egg

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Jong Ho Lee

Professor, PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 31685797 (View on PubMed)

Other Identifiers

RCK_OFTT

Identifier Type: -

Identifier Source: org_study_id