Effects of D-allulose (Psicose) With Sucrose Beverage on Glucose Tolerance and Insulin Level
Condition: Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

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
    

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
    

Intervention name(s): D-allulose
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention