Completed

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

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What is being tested

D-allulose

Dietary Supplement
Who is being recruted

Hyperglycemia+2

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 18 to 85 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: April 2015
See protocol details

Summary

Principal SponsorChiang Mai University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

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

Official TitleThe 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
NCT02455934
Principal SponsorChiang Mai University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

HyperglycemiaMetabolic DiseasesNutritional and Metabolic DiseasesGlucose IntoleranceGlucose Metabolism Disorders

Criteria

5 inclusion criteria required to participate
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.

Show More Criteria

10 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

20% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Sucrose 50 g + D-allulose (psicose) 2.5 g

Group II

Active Comparator
Sucrose 50 g + D-allulose (psicose) 10 g

Group III

Active Comparator
Sucrose 50 g + D-allulose (psicose) 5 g

Group IV

Active Comparator
Sucrose 50 g + D-allulose (psicose) 7.5 g

Group 5

Placebo
Sucrose 50 g

Study 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

Suspended

Clinical trial Unit, Faculty of Medicine, Chiang Mai University

Muang, ThailandOpen Clinical trial Unit, Faculty of Medicine, Chiang Mai University in Google Maps
CompletedOne Study Center