Postprandial HyperglycemiaNCT02654301
Beneficial Effect of Xylose Consumption on Postprandial Hyperglycemia
A study testing Test 1, Test 2 and Test 3 in people with Postprandial Hyperglycemia, run by Yonsei University.
Trial summary
The present study determined the effect of Xylose consumption on postprandial hyperglycemia in normal (n=25) and hyperglycemic subjects (n=50). Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia
- What is being tested?
- Test 1, Test 2 and Test 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Feb 2015
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) healthy subject or Impaired fasting glucose (fasting serum glucose between 100 and 125 mg/dL)
Who cannot join
- history of taking an insulin-injection or oral hypoglycemic agents
- evidence of alcohol abuse or alcoholism
- pregnancy or breast feeding
- chronic gastrointestinal disorder
- seriously abnormal liver or renal function
- an occupation at risk of death when hypoglycemia occurs
About this study
Official title: Beneficial Effect of Xylose Consumption on Postprandial Hyperglycemia in Subjects With Normal Glucose Level and Impaired Fasting Glucose
The present study determined the effect of Xylose consumption on postprandial hyperglycemia in normal (n=25) and hyperglycemic subjects (n=50).
Read the detailed description
In this double-blind crossover designed study, Participants were randomly assigned to consume a sucrose drink (Control, sucrose 50g + deionized water 100g) or a sucrose drink additionally containing 5 g (Test 1, sucrose : xylose = 10:1), 3.33 g (Test 2, sucrose : xylose = 15:1) or 2.5 g (Test 3, sucrose : xylose = 20:1) of D-xylose with a week interval.
- Conditions
- Postprandial Hyperglycemia
- Being tested
- Test 1, Test 2, Test 3, Control
- Keywords
- Xylose, prediabetes, postprandial hyperglycemia, glucose
- Medical subject headings
- Hyperglycemia, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test 1Dietary supplement
sucrose : xylose = 10:1, sucrose 50 g + xylose 5 g + deionized water 95 g
Test 2Dietary supplement
sucrose : xylose = 15:1, sucrose 50 g + xylose 3.33 g + deionized water 96.67 g
Test 3Dietary supplement
sucrose : xylose = 20:1, sucrose 50 g + xylose 2.5 g + deionized water 97.5 g
ControlDietary supplement
sucrose 50 g + deionized water 100 g
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | sucrose drink (Control, sucrose 50g + deionized water 100g) Receives: Dietary Supplement: Control |
| 5 g xylose group | Active comparator | 5 g xylose (Test 1, sucrose : xylose = 10:1), Receives: Dietary Supplement: Test 1 |
| 3.33 g xylose group | Active comparator | 3.33 g xylose (Test 2, sucrose : xylose = 15:1) Receives: Dietary Supplement: Test 2 |
| 2.5 g xylose group | Active comparator | 2.5 g xylose (Test 3, sucrose : xylose = 20:1) Receives: Dietary Supplement: Test 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of serum glucose levels
Measured: a week interval
Secondary outcomes (2)
Change of serum insulin levels
Measured: a week interval
Change of serum C-peptide levels
Measured: a week interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionFeb 2015
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 Postprandial HyperglycemiaStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Ho Lee, Yonsei University
- Investigators
- Jong Ho Lee, Ph.D, Principal investigator, Laboratory of clinical nutrigenetics/nutrigenomics, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654301
- Sponsor's protocol ID
- Xylose_2015
- Status last verified
- Aug 2015
- First submitted
- 26 Aug 2015
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Jun YJ, Lee J, Hwang S, Kwak JH, Ahn HY, Bak YK, Koh J, Lee JH. Beneficial effect of xylose consumption on postprandial hyperglycemia in Korean: a randomized double-blind, crossover design. Trials. 2016 Mar 15;17(1):139. doi: 10.1186/s13063-016-1261-0.
PubMed 26979433
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effect of Xylose Consumption on Postprandial Hyperglycemia in Subjects With Normal Glucose Level and Impaired Fasting Glucose
- ClinicalTrials.gov ID
- NCT02654301
- Acronym / sponsor ID
- Xylose_2015
- Conditions
- Postprandial Hyperglycemia
- Keywords
- Xylose, prediabetes, postprandial hyperglycemia, glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 13 Jan 2016 (estimated)
- 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.
The present study determined the effect of Xylose consumption on postprandial hyperglycemia in normal (n=25) and hyperglycemic subjects (n=50).
Detailed description
In this double-blind crossover designed study, Participants were randomly assigned to consume a sucrose drink (Control, sucrose 50g + deionized water 100g) or a sucrose drink additionally containing 5 g (Test 1, sucrose : xylose = 10:1), 3.33 g (Test 2, sucrose : xylose = 15:1) or 2.5 g (Test 3, sucrose : xylose = 20:1) of D-xylose with a week interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: Controlsucrose drink (Control, sucrose 50g + deionized water 100g) |
| 5 g xylose group | Active comparator | Dietary Supplement: Test 15 g xylose (Test 1, sucrose : xylose = 10:1), |
| 3.33 g xylose group | Active comparator | Dietary Supplement: Test 23.33 g xylose (Test 2, sucrose : xylose = 15:1) |
| 2.5 g xylose group | Active comparator | Dietary Supplement: Test 32.5 g xylose (Test 3, sucrose : xylose = 20:1) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) healthy subject or Impaired fasting glucose (fasting serum glucose between 100 and 125 mg/dL)
Key exclusion criteria (6 listed)
- history of taking an insulin-injection or oral hypoglycemic agents
- evidence of alcohol abuse or alcoholism
- pregnancy or breast feeding
- chronic gastrointestinal disorder
- seriously abnormal liver or renal function
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 |
|---|---|---|
| Test 1sucrose : xylose = 10:1, sucrose 50 g + xylose 5 g + deionized water 95 g | Dietary supplement | 5 g xylose group |
| Test 2sucrose : xylose = 15:1, sucrose 50 g + xylose 3.33 g + deionized water 96.67 g | Dietary supplement | 3.33 g xylose group |
| Test 3sucrose : xylose = 20:1, sucrose 50 g + xylose 2.5 g + deionized water 97.5 g | Dietary supplement | 2.5 g xylose group |
| Controlsucrose 50 g + deionized water 100 g | Dietary supplement | Control group |
Primary outcome
Change of serum glucose levels
Time frame: a week interval
2 secondary outcomes
Change of serum insulin levels
Time frame: a week interval
Change of serum C-peptide levels
Time frame: a week interval
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 13 Jan 2016.
- Derived from this study: PubMed 26979433Jun YJ, Lee J, Hwang S, Kwak JH, Ahn HY, Bak YK, Koh J, Lee JH. Beneficial effect of xylose consumption on postprandial hyperglycemia in Korean: a randomized double-blind, crossover design. Trials. 2016 Mar 15;17(1):139. doi: 10.1186/s13063-016-1261-0.
Related trials for Postprandial Hyperglycemia
Active, not recruiting
How Fig Polyphenols Affect Blood Sugar and Insulin Levels After Eating in Adults at Risk for Diabetes
Pre Diabetic
Enrolling by invitation
Development of Anti-Diabetic Nutraceuticals From Legume Seed Coats
Postprandial Hyperglycemia, Type 2 Diabetes
Active, not recruiting
Effect of a Sugar Replacement on Blood Glucose Levels in Healthy Adults
Postprandial Hyperglycemia, Hyperinsulinemia
Recruiting
Ultra-processed Food-reducing Intervention and Continuous Glucose Monitoring
Postprandial Glucose, Glucose Levels
Not yet recruiting
Effect of a Food Supplement on Glycemic Parameters in Patients With Impaired Glucose Metabolism
Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (Prediabetes)
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.
Jong Ho Lee, Ph.D principal investigator
Laboratory of clinical nutrigenetics/nutrigenomics, Yonsei University
Questions about this trial
What is this clinical trial studying?
A study testing Test 1, Test 2 and Test 3 in people with Postprandial Hyperglycemia, run by Yonsei University.
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 1 inclusion and 6 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 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change of serum glucose levels (time frame: a week interval). 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 NCT02654301, 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 13 Jan 2016.