Clinical trial NCT03650023: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Glucose levels
timeFrame: 2 hours
Secondary outcomes:
measure: The areas under the curve (AUC) of glucose
timeFrame: 1 day of second visit (after finishing cross-over trial)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Study officials:
References:
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.