Impaired Glucose ToleranceNCT02455934
Effects of D-allulose (Psicose) With Sucrose Beverage on Glucose Tolerance and Insulin Level
A study testing D-allulose in people with Impaired Glucose Tolerance, run by Chiang Mai University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Glucose Tolerance
- What is being tested?
- D-allulose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Clinical trial Unit, Faculty of Medicine, Chiang Mai University
Muang, ChiangMai, 50200
About this study
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
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
Read the 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
- Conditions
- Impaired Glucose Tolerance
- Being tested
- D-allulose
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-alluloseDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Sucrose | Placebo comparator | Sucrose 50 g Receives: Dietary Supplement: D-allulose |
| SAlloulose2.5 | Active comparator | Sucrose 50 g + D-allulose (psicose) 2.5 g Receives: Dietary Supplement: D-allulose |
| SAllulose5 | Active comparator | Sucrose 50 g + D-allulose (psicose) 5 g Receives: Dietary Supplement: D-allulose |
| SAllulose7.5 | Active comparator | Sucrose 50 g + D-allulose (psicose) 7.5 g Receives: Dietary Supplement: D-allulose |
| SAllulose10 | Active comparator | Sucrose 50 g + D-allulose (psicose) 10 g Receives: Dietary Supplement: D-allulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose-response effects of D-allulose (psicose) with sucrose beverage on glucose tolerance
oral sucrose tolerance test with sucrose +/- allulose
Measured: 2 hours
Secondary outcomes (1)
Time to peak plasma glucose concentration
oral sucrose tolerance test with sucrose +/- allulose
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Impaired Glucose ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Collaborators
- Kagawa University
- Responsible party
- Principal investigator, Supawan Buranapin, Chiang Mai University
- Investigators
- Supawan Buranapin, MD, Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455934
- Sponsor's protocol ID
- CMU-D-alloluse01
- Status last verified
- Jan 2016
- First submitted
- 23 Feb 2015
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cree GM, Perlin AS. O-isopropylidene derivatives of D-allulose (D-psicose) and D-erythro-hexopyranos-2,3-diulose. Can J Biochem. 1968 Aug;46(8):765-70. doi: 10.1139/o68-117. No abstract available.
PubMed 4299740Takeshita K, Suga A, Takada G, Izumori K. Mass production of D-psicose from d-fructose by a continuous bioreactor system using immobilized D-tagatose 3-epimerase. J Biosci Bioeng. 2000;90(4):453-5. doi: 10.1016/s1389-1723(01)80018-9.
PubMed 16232889Granstrom TB, Takata G, Tokuda M, Izumori K. Izumoring: a novel and complete strategy for bioproduction of rare sugars. J Biosci Bioeng. 2004;97(2):89-94. doi: 10.1016/S1389-1723(04)70173-5.
PubMed 16233597Matsuo T, Suzuki H, Hashiguchi M, Izumori K. D-psicose is a rare sugar that provides no energy to growing rats. J Nutr Sci Vitaminol (Tokyo). 2002 Feb;48(1):77-80. doi: 10.3177/jnsv.48.77.
PubMed 12026195Matsuo T, Izumori K. d-Psicose Inhibits Intestinal alpha-Glucosidase and Suppresses the Glycemic Response after Ingestion of Carbohydrates in Rats. J Clin Biochem Nutr. 2009 Sep;45(2):202-6. doi: 10.3164/jcbn.09-36. Epub 2009 Aug 28.
PubMed 19794929Iida T, Kishimoto Y, Yoshikawa Y, Hayashi N, Okuma K, Tohi M, Yagi K, Matsuo T, Izumori K. Acute D-psicose administration decreases the glycemic responses to an oral maltodextrin tolerance test in normal adults. J Nutr Sci Vitaminol (Tokyo). 2008 Dec;54(6):511-4. doi: 10.3177/jnsv.54.511.
PubMed 19155592Hayashi N, Iida T, Yamada T, Okuma K, Takehara I, Yamamoto T, Yamada K, Tokuda M. Study on the postprandial blood glucose suppression effect of D-psicose in borderline diabetes and the safety of long-term ingestion by normal human subjects. Biosci Biotechnol Biochem. 2010;74(3):510-9. doi: 10.1271/bbb.90707. Epub 2010 Mar 7.
PubMed 20208358Hossain A, Yamaguchi F, Matsunaga T, Hirata Y, Kamitori K, Dong Y, Sui L, Tsukamoto I, Ueno M, Tokuda M. Rare sugar D-psicose protects pancreas beta-islets and thus improves insulin resistance in OLETF rats. Biochem Biophys Res Commun. 2012 Sep 7;425(4):717-23. doi: 10.1016/j.bbrc.2012.07.135. Epub 2012 Aug 1.
PubMed 22877751Ochiai M, Onishi K, Yamada T, Iida T, Matsuo T. D-psicose increases energy expenditure and decreases body fat accumulation in rats fed a high-sucrose diet. Int J Food Sci Nutr. 2014 Mar;65(2):245-50. doi: 10.3109/09637486.2013.845653. Epub 2013 Oct 21.
PubMed 24144428Matsuo T, Izumori K. Effects of dietary D-psicose on diurnal variation in plasma glucose and insulin concentrations of rats. Biosci Biotechnol Biochem. 2006 Sep;70(9):2081-5. doi: 10.1271/bbb.60036. Epub 2006 Sep 7.
PubMed 16960391Ochiai M, Nakanishi Y, Yamada T, Iida T, Matsuo T. Inhibition by dietary D-psicose of body fat accumulation in adult rats fed a high-sucrose diet. Biosci Biotechnol Biochem. 2013;77(5):1123-6. doi: 10.1271/bbb.130019. Epub 2013 May 7.
PubMed 23649241Chung YM, Hyun Lee J, Youl Kim D, Hwang SH, Hong YH, Kim SB, Jin Lee S, Hye Park C. Dietary D-psicose reduced visceral fat mass in high-fat diet-induced obese rats. J Food Sci. 2012 Feb;77(2):H53-8. doi: 10.1111/j.1750-3841.2011.02571.x.
PubMed 22339545Wong JM, de Souza R, Kendall CW, Emam A, Jenkins DJ. Colonic health: fermentation and short chain fatty acids. J Clin Gastroenterol. 2006 Mar;40(3):235-43. doi: 10.1097/00004836-200603000-00015.
PubMed 16633129
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02455934
- Acronym / sponsor ID
- CMU-D-alloluse01
- Conditions
- Impaired Glucose Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Collaborators
- Kagawa University
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sucrose | Placebo comparator | Dietary Supplement: D-alluloseSucrose 50 g |
| SAlloulose2.5 | Active comparator | Dietary Supplement: D-alluloseSucrose 50 g + D-allulose (psicose) 2.5 g |
| SAllulose5 | Active comparator | Dietary Supplement: D-alluloseSucrose 50 g + D-allulose (psicose) 5 g |
| SAllulose7.5 | Active comparator | Dietary Supplement: D-alluloseSucrose 50 g + D-allulose (psicose) 7.5 g |
| SAllulose10 | Active comparator | Dietary Supplement: D-alluloseSucrose 50 g + D-allulose (psicose) 10 g |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-alluloseEligible 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. | Dietary supplement | SAlloulose2.5, SAllulose10, SAllulose5, SAllulose7.5, Sucrose |
Primary outcome
The dose-response effects of D-allulose (psicose) with sucrose beverage on glucose tolerance
Time frame: 2 hours
oral sucrose tolerance test with sucrose +/- allulose
1 secondary outcome
Time to peak plasma glucose concentration
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Background: PubMed 4299740Cree GM, Perlin AS. O-isopropylidene derivatives of D-allulose (D-psicose) and D-erythro-hexopyranos-2,3-diulose. Can J Biochem. 1968 Aug;46(8):765-70. doi: 10.1139/o68-117. No abstract available.
- Background: PubMed 16232889Takeshita K, Suga A, Takada G, Izumori K. Mass production of D-psicose from d-fructose by a continuous bioreactor system using immobilized D-tagatose 3-epimerase. J Biosci Bioeng. 2000;90(4):453-5. doi: 10.1016/s1389-1723(01)80018-9.
- Background: PubMed 16233597Granstrom TB, Takata G, Tokuda M, Izumori K. Izumoring: a novel and complete strategy for bioproduction of rare sugars. J Biosci Bioeng. 2004;97(2):89-94. doi: 10.1016/S1389-1723(04)70173-5.
- Background: PubMed 12026195Matsuo T, Suzuki H, Hashiguchi M, Izumori K. D-psicose is a rare sugar that provides no energy to growing rats. J Nutr Sci Vitaminol (Tokyo). 2002 Feb;48(1):77-80. doi: 10.3177/jnsv.48.77.
- Background: PubMed 19794929Matsuo T, Izumori K. d-Psicose Inhibits Intestinal alpha-Glucosidase and Suppresses the Glycemic Response after Ingestion of Carbohydrates in Rats. J Clin Biochem Nutr. 2009 Sep;45(2):202-6. doi: 10.3164/jcbn.09-36. Epub 2009 Aug 28.
- Background: PubMed 19155592Iida T, Kishimoto Y, Yoshikawa Y, Hayashi N, Okuma K, Tohi M, Yagi K, Matsuo T, Izumori K. Acute D-psicose administration decreases the glycemic responses to an oral maltodextrin tolerance test in normal adults. J Nutr Sci Vitaminol (Tokyo). 2008 Dec;54(6):511-4. doi: 10.3177/jnsv.54.511.
- Background: PubMed 20208358Hayashi N, Iida T, Yamada T, Okuma K, Takehara I, Yamamoto T, Yamada K, Tokuda M. Study on the postprandial blood glucose suppression effect of D-psicose in borderline diabetes and the safety of long-term ingestion by normal human subjects. Biosci Biotechnol Biochem. 2010;74(3):510-9. doi: 10.1271/bbb.90707. Epub 2010 Mar 7.
- Background: PubMed 22877751Hossain A, Yamaguchi F, Matsunaga T, Hirata Y, Kamitori K, Dong Y, Sui L, Tsukamoto I, Ueno M, Tokuda M. Rare sugar D-psicose protects pancreas beta-islets and thus improves insulin resistance in OLETF rats. Biochem Biophys Res Commun. 2012 Sep 7;425(4):717-23. doi: 10.1016/j.bbrc.2012.07.135. Epub 2012 Aug 1.
- Background: PubMed 24144428Ochiai M, Onishi K, Yamada T, Iida T, Matsuo T. D-psicose increases energy expenditure and decreases body fat accumulation in rats fed a high-sucrose diet. Int J Food Sci Nutr. 2014 Mar;65(2):245-50. doi: 10.3109/09637486.2013.845653. Epub 2013 Oct 21.
- Background: PubMed 16960391Matsuo T, Izumori K. Effects of dietary D-psicose on diurnal variation in plasma glucose and insulin concentrations of rats. Biosci Biotechnol Biochem. 2006 Sep;70(9):2081-5. doi: 10.1271/bbb.60036. Epub 2006 Sep 7.
- Background: PubMed 23649241Ochiai M, Nakanishi Y, Yamada T, Iida T, Matsuo T. Inhibition by dietary D-psicose of body fat accumulation in adult rats fed a high-sucrose diet. Biosci Biotechnol Biochem. 2013;77(5):1123-6. doi: 10.1271/bbb.130019. Epub 2013 May 7.
- Background: PubMed 22339545Chung YM, Hyun Lee J, Youl Kim D, Hwang SH, Hong YH, Kim SB, Jin Lee S, Hye Park C. Dietary D-psicose reduced visceral fat mass in high-fat diet-induced obese rats. J Food Sci. 2012 Feb;77(2):H53-8. doi: 10.1111/j.1750-3841.2011.02571.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Supawan Buranapin, MD principal investigator
Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-allulose in people with Impaired Glucose Tolerance, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The dose-response effects of D-allulose (psicose) with sucrose beverage on glucose tolerance (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02455934, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.