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
D-allulose
Hyperglycemia+2
+ Metabolic Diseases
+ Nutritional and Metabolic Diseases
Prevention Study
Summary
Study start date: April 1, 2015
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.5 intervention groups are designated in this study
20% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorGroup III
Active ComparatorGroup IV
Active ComparatorGroup 5
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Clinical trial Unit, Faculty of Medicine, Chiang Mai University
Muang, ThailandOpen Clinical trial Unit, Faculty of Medicine, Chiang Mai University in Google Maps