Beneficial Effect of Xylose Consumption on Postprandial Hyperglycemia

January 12, 2016 updated by: Jong Ho Lee, Yonsei University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
sucrose drink (Control, sucrose 50g + deionized water 100g)
Dietary supplement: Control
sucrose 50 g + deionized water 100 g
Active Comparator: 5 g xylose group
5 g xylose (Test 1, sucrose : xylose = 10:1),
Dietary supplement: Test 1
sucrose : xylose = 10:1, sucrose 50 g + xylose 5 g + deionized water 95 g
Active Comparator: 3.33 g xylose group
3.33 g xylose (Test 2, sucrose : xylose = 15:1)
Dietary supplement: Test 2
sucrose : xylose = 15:1, sucrose 50 g + xylose 3.33 g + deionized water 96.67 g
Active Comparator: 2.5 g xylose group
2.5 g xylose (Test 3, sucrose : xylose = 20:1)
Dietary supplement: Test 3
sucrose : xylose = 20:1, sucrose 50 g + xylose 2.5 g + deionized water 97.5 g

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of serum glucose levels
Time Frame: a week interval
a week interval

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of serum insulin levels
Time Frame: a week interval
a week interval
Change of serum C-peptide levels
Time Frame: a week interval
a week interval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Jong Ho Lee, Ph.D, Laboratory of clinical nutrigenetics/nutrigenomics, Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

August 26, 2015

First Submitted That Met QC Criteria

January 12, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xylose_2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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