Beneficial Effect of Xylose Consumption on Postprandial Hyperglycemia

Postprandial Hyperglycemia Clinical Trial

Official title:

Beneficial Effect of Xylose Consumption on Postprandial Hyperglycemia in Subjects With Normal Glucose Level and Impaired Fasting Glucose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654301
• Other study ID #: Xylose_2015
• Status: Completed
• Phase: N/A
• First received: August 26, 2015
• Last updated: January 12, 2016
• Start date: June 2014
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The present study determined the effect of Xylose consumption on postprandial hyperglycemia in normal (n=25) and hyperglycemic subjects (n=50).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1) healthy subject or Impaired fasting glucose (fasting serum glucose between 100 and 125 mg/dL)

Exclusion Criteria:

1. history of taking an insulin-injection or oral hypoglycemic agents

2. evidence of alcohol abuse or alcoholism

3. pregnancy or breast feeding

4. chronic gastrointestinal disorder

5. seriously abnormal liver or renal function

6. an occupation at risk of death when hypoglycemia occurs

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperglycemia
• Postprandial Hyperglycemia

Intervention

Dietary Supplement:
• Test 1
sucrose : xylose = 10:1, sucrose 50 g + xylose 5 g + deionized water 95 g
• Test 2
sucrose : xylose = 15:1, sucrose 50 g + xylose 3.33 g + deionized water 96.67 g
• Test 3
sucrose : xylose = 20:1, sucrose 50 g + xylose 2.5 g + deionized water 97.5 g
• Control
sucrose 50 g + deionized water 100 g

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of serum glucose levels		a week interval	Yes
Secondary	Change of serum insulin levels		a week interval	Yes
Secondary	Change of serum C-peptide levels		a week interval	Yes