NCT03650023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 26, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

August 26, 2018

Last Update Submit

August 26, 2018

Conditions

NormalImpaired Fasting GlucoseImpaired Glucose Tolerance

Keywords

Chitosan Oligosaccharidediabetes mellitusblood glucosefasting blood sugarnormal blood glucoseimpaired fasting glucoseImpaired Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

  • Glucose levels

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

    2 hours

Secondary Outcomes (1)

  • The areas under the curve (AUC) of glucose

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

Study Arms (2)

Chitosan Oligosaccharide (GO2KA1)

EXPERIMENTAL

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)

White egg

PLACEBO COMPARATOR

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

Interventions

Chitosan Oligosaccharide (GO2KA1)DIETARY_SUPPLEMENT

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

Chitosan Oligosaccharide (GO2KA1)
White eggDIETARY_SUPPLEMENT

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

White egg

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Seoul, 03722, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 31685797DERIVED

MeSH Terms

Conditions

Glucose IntoleranceDiabetes Mellitus

Interventions

GO2KA1Egg White

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

EggsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PI

Study Record Dates

First Submitted

August 26, 2018

First Posted

August 28, 2018

Study Start

May 9, 2018

Primary Completion

July 25, 2018

Study Completion

July 25, 2018

Last Updated

August 28, 2018

Record last verified: 2018-08

Locations

KR(1)