NCT02654301

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
Last Updated

January 13, 2016

Status Verified

August 1, 2015

Enrollment Period

6 months

First QC Date

August 26, 2015

Last Update Submit

January 12, 2016

Conditions

Keywords

Xyloseprediabetespostprandial hyperglycemiaglucose

Outcome Measures

Primary Outcomes (1)

  • Change of serum glucose levels

    a week interval

Secondary Outcomes (2)

  • Change of serum insulin levels

    a week interval

  • Change of serum C-peptide levels

    a week interval

Study Arms (4)

Control group

PLACEBO COMPARATOR

sucrose drink (Control, sucrose 50g + deionized water 100g)

Dietary Supplement: Control

5 g xylose group

ACTIVE COMPARATOR

5 g xylose (Test 1, sucrose : xylose = 10:1),

Dietary Supplement: Test 1

3.33 g xylose group

ACTIVE COMPARATOR

3.33 g xylose (Test 2, sucrose : xylose = 15:1)

Dietary Supplement: Test 2

2.5 g xylose group

ACTIVE COMPARATOR

2.5 g xylose (Test 3, sucrose : xylose = 20:1)

Dietary Supplement: Test 3

Interventions

Test 1DIETARY_SUPPLEMENT

sucrose : xylose = 10:1, sucrose 50 g + xylose 5 g + deionized water 95 g

5 g xylose group
Test 2DIETARY_SUPPLEMENT

sucrose : xylose = 15:1, sucrose 50 g + xylose 3.33 g + deionized water 96.67 g

3.33 g xylose group
Test 3DIETARY_SUPPLEMENT

sucrose : xylose = 20:1, sucrose 50 g + xylose 2.5 g + deionized water 97.5 g

2.5 g xylose group
ControlDIETARY_SUPPLEMENT

sucrose 50 g + deionized water 100 g

Control group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

HyperglycemiaPrediabetic State

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Study Officials

  • Jong Ho Lee, Ph.D

    Laboratory of clinical nutrigenetics/nutrigenomics, Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Food and Nutrition

Study Record Dates

First Submitted

August 26, 2015

First Posted

January 13, 2016

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

January 13, 2016

Record last verified: 2015-08