Effects of D-allulose (Psicose) With Sucrose Beverage on Glucose Tolerance and Insulin Level
Primary Purpose
Impaired Glucose Tolerance
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
D-allulose
Sponsored by
About this trial
This is an interventional prevention trial for Impaired Glucose Tolerance
Eligibility Criteria
Inclusion Criteria:
- Male or female, age > 18 years and legal age of consent.
- If female, the participant is either post-menopausal or surgically sterilized, or has a negative urine kit pregnancy test within 7 days prior to enrollment and will use adequate contraception during the study.
- The participant has provided written informed consent prior to admission to the study.
- Participant is able to join the entire study with 8 weeks.
- Participant is able to keep 24-hour dietary record a day prior to each visit.
Exclusion Criteria:
- Pregnancy or lactation
- Diagnosed with diabetes mellitus
- Those who take any medication that might be able to increase plasma glucose 1 month prior to the study or during in the study
- Acute illness within 1 weeks prior to the study
- Has gastrointestinal symptoms such as nausea, vomiting, loss of appetite, premature satiety, diarrhea, or chronic constipation
- Immunocompromised status, including a debilitated state or malignancy
- Active liver, renal, thyroid diseases
- Lack of ability or willingness to give informed consent
- Enrolled in any other clinical study within 3 months before enrolment
- Any people whose life style is irregular, for example, person works at night shifts.
Sites / Locations
- Clinical trial Unit, Faculty of Medicine, Chiang Mai University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Sucrose
SAlloulose2.5
SAllulose5
SAllulose7.5
SAllulose10
Arm Description
Sucrose 50 g
Sucrose 50 g + D-allulose (psicose) 2.5 g
Sucrose 50 g + D-allulose (psicose) 5 g
Sucrose 50 g + D-allulose (psicose) 7.5 g
Sucrose 50 g + D-allulose (psicose) 10 g
Outcomes
Primary Outcome Measures
The dose-response effects of D-allulose (psicose) with sucrose beverage on glucose tolerance
oral sucrose tolerance test with sucrose +/- allulose
Secondary Outcome Measures
Time to peak plasma glucose concentration
oral sucrose tolerance test with sucrose +/- allulose
Full Information
NCT ID
NCT02455934
First Posted
February 23, 2015
Last Updated
January 30, 2016
Sponsor
Chiang Mai University
Collaborators
Kagawa University
1. Study Identification
Unique Protocol Identification Number
NCT02455934
Brief Title
Effects of D-allulose (Psicose) With Sucrose Beverage on Glucose Tolerance and Insulin Level
Official Title
The Dose-response Effects of D-allulose (Psicose) With Sucrose Beverage on Glucose Tolerance and Insulin Level in Healthy Volunteers and Volunteers With Impaired Fasting Glucose
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University
Collaborators
Kagawa University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Randomized, double-blind, crossover-trial, 30 subjects in each groups, either males or females, normal fasting glucose or pre-diabetes, aged > 18 years old to perform oral sucrose tolerance with either one of the 5 study products
Sucrose 50 g
Sucrose 50 g + D-allulose (psicose) 2.5 g
Sucrose 50 g + D-allulose (psicose) 5 g
Sucrose 50 g + D-allulose (psicose) 7.5 g
Sucrose 50 g + D-allulose (psicose) 10 g
Primary endpoints:
To investigate the dose-response effects of D- allulose (psicose) with sucrose beverage on glucose tolerance
To investigate the dose-response effects of D- allulose (psicose) with sucrose beverage on insulin levels
Detailed Description
Objectives Primary objectives
To investigate the dose-response effects of D-allulose (psicose) with sucrose beverage on glucose tolerance
To investigate the dose-response effects of D-allulose (psicose) with sucrose beverage on insulin levels
Subjects and methods Study product A. Sucrose 50 g B. Sucrose 50 g + D-allulose (psicose) 2.5 g C. Sucrose 50 g + D-allulose (psicose) 5 g D. Sucrose 50 g + D-allulose (psicose) 7.5 g E. Sucrose 50 g + D-allulose (psicose) 10 g
Study plan Screening (visit 0)
Obtain inform consent
History taking for medical problems, smoking, alcoholic drinking, concurrent medication, contraception or menopausal status, weight history
Measure body weight, height and calculated BMI
Measure waist and hip circumference
Body composition measurement by bioelectrical impedance analysis (BIA)
Complete physical examination
Urine pregnancy test in all female of childbearing potential
Provide 24-hour food record
Ask to come back within 1 week
Visit 1: (day 7 or 6-11 days)
Complete physical examination
Randomize subject to receive any 1 of 5 study products
Perform OSTT with that product
Return food record
Provide 24-hour food record
Adverse events evaluation
Ask to come back within 7 +/- 4 days
Visit 2: (day 7 or 6-11 days from visit 1)
Complete physical examination
Randomize subject to receive any 1 of 4 study product which are left
Perform OSTT with that product
Return food record
Provide 24-hour food record
Adverse events evaluation
Ask to come back within 7 +/- 4 days
Visit 3 (day 7 or 6-11 days from visit 2)
Complete physical examination
Randomize subject to receive any 1 of 3 study product which are left
Perform OSTT with that product
Return food record
Provide 24-hour food record
Adverse events evaluation
Ask to come back within 7 +/- 4 days
Visit 4 (day 7 or 6-11 days from visit 3)
Complete physical examination
Randomize subject to receive any 1 of 2 study product which are left
Perform OSTT with that product
Return food record
Provide 24-hour food record
Adverse events evaluation
Ask to come back within 7 +/- 4 days
Visit 5 (day 7 or 6-11 days from visit 4)
Complete physical examination
Perform OSTT with the product that is left
Return food record
Adverse events evaluation
Adverse Event Assessment At each visit, participants will be asked an open question as if he/she has experienced any abnormal symptoms. Any symptom reported by the participants will be recorded as an adverse events with details of the event, its severity, start and stop dates, and relationship to study products. Gastrointestinal symptoms (heartburn, distension, nausea, vomiting, abdominal pain, flatulence, constipation and diarrhea) within 24 hours after OSTT will be asked and recorded as well.
Withdrawal criteria
Those who are not able to complete 5 visits of OSTT within 8 weeks
Those who cannot provide 24-hour dietary record at each visit
Those who start any medication that might cause increasing in plasma glucose during participating in the study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sucrose
Arm Type
Placebo Comparator
Arm Description
Sucrose 50 g
Arm Title
SAlloulose2.5
Arm Type
Active Comparator
Arm Description
Sucrose 50 g + D-allulose (psicose) 2.5 g
Arm Title
SAllulose5
Arm Type
Active Comparator
Arm Description
Sucrose 50 g + D-allulose (psicose) 5 g
Arm Title
SAllulose7.5
Arm Type
Active Comparator
Arm Description
Sucrose 50 g + D-allulose (psicose) 7.5 g
Arm Title
SAllulose10
Arm Type
Active Comparator
Arm Description
Sucrose 50 g + D-allulose (psicose) 10 g
Intervention Type
Dietary Supplement
Intervention Name(s)
D-allulose
Intervention Description
Eligible subjects will come for visit 1 to consume varying dose of D-allulose with sucrose beverage with 1 of 5 beverages in a random order which will be blinded for both subjects and investigators. They will have to do 24-hour dietary record a day prior to each visit. Subjects have to be abstained from energy diet within 8 hours prior to each visit. Venous blood samples will be collected 6 mL for measurement of FPG and insulin before taking any study product. Subjects have to drink all within 1 minute. Blood samples will be drawn again 6 mL at 30, 60, 90 and 120 min after consumption for measurement of PG and insulin. Every subject will be asked to come back to finish OSTT with 5 study products in a random order, each at 7 days or >5 days and <12 days apart.
Primary Outcome Measure Information:
Title
The dose-response effects of D-allulose (psicose) with sucrose beverage on glucose tolerance
Description
oral sucrose tolerance test with sucrose +/- allulose
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Time to peak plasma glucose concentration
Description
oral sucrose tolerance test with sucrose +/- allulose
Time Frame
2 hours
Other Pre-specified Outcome Measures:
Title
The dose-response effects of D-allulose with sucrose beverage on insulin levels after oral sucrose tolerance test
Description
Oral sucrose tolerance test with sucrose +/- allulose
Time Frame
2 hours
Title
Time to peak plasma insulin concentration
Description
Oral sucrose tolerance test with sucrose +/- allulose
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female, age > 18 years and legal age of consent.
If female, the participant is either post-menopausal or surgically sterilized, or has a negative urine kit pregnancy test within 7 days prior to enrollment and will use adequate contraception during the study.
The participant has provided written informed consent prior to admission to the study.
Participant is able to join the entire study with 8 weeks.
Participant is able to keep 24-hour dietary record a day prior to each visit.
Exclusion Criteria:
Pregnancy or lactation
Diagnosed with diabetes mellitus
Those who take any medication that might be able to increase plasma glucose 1 month prior to the study or during in the study
Acute illness within 1 weeks prior to the study
Has gastrointestinal symptoms such as nausea, vomiting, loss of appetite, premature satiety, diarrhea, or chronic constipation
Immunocompromised status, including a debilitated state or malignancy
Active liver, renal, thyroid diseases
Lack of ability or willingness to give informed consent
Enrolled in any other clinical study within 3 months before enrolment
Any people whose life style is irregular, for example, person works at night shifts.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Supawan Buranapin, MD
Organizational Affiliation
Chiang Mai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical trial Unit, Faculty of Medicine, Chiang Mai University
City
Muang
State/Province
ChiangMai
ZIP/Postal Code
50200
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
4299740
Citation
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Results Reference
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Citation
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Effects of D-allulose (Psicose) With Sucrose Beverage on Glucose Tolerance and Insulin Level
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