Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-02-25 @ 11:04 PM
Study NCT ID:
NCT02455934
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2015-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of D-allulose (Psicose) With Sucrose Beverage on Glucose Tolerance and Insulin Level
Sponsor:
Chiang Mai University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
1. Sucrose 50 g
2. Sucrose 50 g + D-allulose (psicose) 2.5 g
3. Sucrose 50 g + D-allulose (psicose) 5 g
4. Sucrose 50 g + D-allulose (psicose) 7.5 g
5. Sucrose 50 g + D-allulose (psicose) 10 g
Primary endpoints:
1. To investigate the dose-response effects of D- allulose (psicose) with sucrose beverage on glucose tolerance
2. To investigate the dose-response effects of D- allulose (psicose) with sucrose beverage on insulin levels
1. Sucrose 50 g
2. Sucrose 50 g + D-allulose (psicose) 2.5 g
3. Sucrose 50 g + D-allulose (psicose) 5 g
4. Sucrose 50 g + D-allulose (psicose) 7.5 g
5. Sucrose 50 g + D-allulose (psicose) 10 g
Primary endpoints:
1. To investigate the dose-response effects of D- allulose (psicose) with sucrose beverage on glucose tolerance
2. To investigate the dose-response effects of D- allulose (psicose) with sucrose beverage on insulin levels
Detailed Description:
Objectives Primary objectives
1. To investigate the dose-response effects of D-allulose (psicose) with sucrose beverage on glucose tolerance
2. 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
1. Those who are not able to complete 5 visits of OSTT within 8 weeks
2. Those who cannot provide 24-hour dietary record at each visit
3. Those who start any medication that might cause increasing in plasma glucose during participating in the study
1. To investigate the dose-response effects of D-allulose (psicose) with sucrose beverage on glucose tolerance
2. 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
1. Those who are not able to complete 5 visits of OSTT within 8 weeks
2. Those who cannot provide 24-hour dietary record at each visit
3. Those who start any medication that might cause increasing in plasma glucose during participating in the study
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: