NormalNCT03650023
A Crossover Trial of Chitosan Oligosaccharide on Post Prandial Glucose Control in Subjects With Normal, IFG and IGT
A study testing Chitosan Oligosaccharide (GO2KA1) and White egg in people with Normal and Impaired Fasting Glucose, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal, Impaired Fasting Glucose, Impaired Glucose Tolerance
- What is being tested?
- Chitosan Oligosaccharide (GO2KA1) and White egg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 May 2018to 25 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Seoul, 03722
About this study
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
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.
Read the 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
- Being tested
- Chitosan Oligosaccharide (GO2KA1), White egg
- Keywords
- Chitosan Oligosaccharide, diabetes mellitus, blood glucose, fasting blood sugar, normal blood glucose, impaired fasting glucose, Impaired Glucose Tolerance
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chitosan Oligosaccharide (GO2KA1)Dietary supplement
Chitosan Oligosaccharide (GO2KA1) capsule was consumed within 15 min, and then 2-h oral sucrose tolerance test was conducted.
White eggDietary supplement
White egg capsule was consumed within 15 min, and then 2-h oral sucrose tolerance test was conducted.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: White egg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose levels
Glucose level differences during the 2-hr oral sucrose tolerance test between White egg and chitosan oligosaccharide (GO2KA1) intak
Measured: 2 hours
Secondary outcomes (1)
The areas under the curve (AUC) of glucose
Glucose AUC differences between White egg and chitosan oligosaccharide (GO2KA1) intake
Measured: 1 day of second visit (after finishing cross-over trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start9 May 2018
- Primary completion25 Jul 2018
- Study completion25 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NormalStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Ho Lee, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650023
- Sponsor's protocol ID
- RCK_OFTT
- Status last verified
- Aug 2018
- First submitted
- 26 Aug 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31685797
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03650023
- Acronym / sponsor ID
- RCK_OFTT
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 9 May 2018 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chitosan Oligosaccharide (GO2KA1) | Experimental | Dietary Supplement: 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. |
| White egg | Placebo comparator | Dietary Supplement: White eggWhite 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. |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chitosan Oligosaccharide (GO2KA1)Chitosan Oligosaccharide (GO2KA1) capsule was consumed within 15 min, and then 2-h oral sucrose tolerance test was conducted. | Dietary supplement | Chitosan Oligosaccharide (GO2KA1) |
| White eggWhite egg capsule was consumed within 15 min, and then 2-h oral sucrose tolerance test was conducted. | Dietary supplement | White egg |
Primary outcome
Glucose levels
Time frame: 2 hours
Glucose level differences during the 2-hr oral sucrose tolerance test between White egg and chitosan oligosaccharide (GO2KA1) intak
1 secondary outcome
The areas under the curve (AUC) of glucose
Time frame: 1 day of second visit (after finishing cross-over trial)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Derived from this study: PubMed 31685797Jeong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chitosan Oligosaccharide (GO2KA1) and White egg in people with Normal and Impaired Fasting Glucose, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose levels (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03650023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.