Back to resultsBeneficial Effect of Xylose Consumption on Postprandial Hyperglycemia
Primary Purpose
Postprandial Hyperglycemia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Test 1
Test 2
Test 3
Control
Sponsored by
About this trial
This is an interventional treatment trial for Postprandial Hyperglycemia focused on measuring Xylose, prediabetes, postprandial hyperglycemia, glucose
Eligibility Criteria
Inclusion Criteria:
1) healthy subject or Impaired fasting glucose (fasting serum glucose between 100 and 125 mg/dL)
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Control group
5 g xylose group
3.33 g xylose group
2.5 g xylose group
Arm Description
sucrose drink (Control, sucrose 50g + deionized water 100g)
5 g xylose (Test 1, sucrose : xylose = 10:1),
3.33 g xylose (Test 2, sucrose : xylose = 15:1)
2.5 g xylose (Test 3, sucrose : xylose = 20:1)
Outcomes
Primary Outcome Measures
Change of serum glucose levels
Secondary Outcome Measures
Change of serum insulin levels
Change of serum C-peptide levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02654301
Brief Title
Beneficial Effect of Xylose Consumption on Postprandial Hyperglycemia
Official Title
Beneficial Effect of Xylose Consumption on Postprandial Hyperglycemia in Subjects With Normal Glucose Level and Impaired Fasting Glucose
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Hyperglycemia
Keywords
Xylose, prediabetes, postprandial hyperglycemia, glucose
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
sucrose drink (Control, sucrose 50g + deionized water 100g)
Arm Title
5 g xylose group
Arm Type
Active Comparator
Arm Description
5 g xylose (Test 1, sucrose : xylose = 10:1),
Arm Title
3.33 g xylose group
Arm Type
Active Comparator
Arm Description
3.33 g xylose (Test 2, sucrose : xylose = 15:1)
Arm Title
2.5 g xylose group
Arm Type
Active Comparator
Arm Description
2.5 g xylose (Test 3, sucrose : xylose = 20:1)
Intervention Type
Dietary Supplement
Intervention Name(s)
Test 1
Intervention Description
sucrose : xylose = 10:1, sucrose 50 g + xylose 5 g + deionized water 95 g
Intervention Type
Dietary Supplement
Intervention Name(s)
Test 2
Intervention Description
sucrose : xylose = 15:1, sucrose 50 g + xylose 3.33 g + deionized water 96.67 g
Intervention Type
Dietary Supplement
Intervention Name(s)
Test 3
Intervention Description
sucrose : xylose = 20:1, sucrose 50 g + xylose 2.5 g + deionized water 97.5 g
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
sucrose 50 g + deionized water 100 g
Primary Outcome Measure Information:
Title
Change of serum glucose levels
Time Frame
a week interval
Secondary Outcome Measure Information:
Title
Change of serum insulin levels
Time Frame
a week interval
Title
Change of serum C-peptide levels
Time Frame
a week interval
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1) healthy subject or Impaired fasting glucose (fasting serum glucose between 100 and 125 mg/dL)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Ho Lee, Ph.D
Organizational Affiliation
Laboratory of clinical nutrigenetics/nutrigenomics, Yonsei University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
26979433
Citation
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.
Results Reference
derived
Learn more about this trial
Beneficial Effect of Xylose Consumption on Postprandial Hyperglycemia
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