Effects of D-allulose (Psicose) With Sucrose Beverage on Glucose Tolerance and Insulin Level

Impaired Glucose Tolerance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455934
• Other study ID #: CMU-D-alloluse01
• Status: Completed
• Phase: N/A
• First received: February 23, 2015
• Last updated: January 30, 2016
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Male or female, age > 18 years and legal age of consent.

2. 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.

3. The participant has provided written informed consent prior to admission to the study.

4. Participant is able to join the entire study with 8 weeks.

5. Participant is able to keep 24-hour dietary record a day prior to each visit.

Exclusion Criteria:

1. Pregnancy or lactation

2. Diagnosed with diabetes mellitus

3. Those who take any medication that might be able to increase plasma glucose 1 month prior to the study or during in the study

4. Acute illness within 1 weeks prior to the study

5. Has gastrointestinal symptoms such as nausea, vomiting, loss of appetite, premature satiety, diarrhea, or chronic constipation

6. Immunocompromised status, including a debilitated state or malignancy

7. Active liver, renal, thyroid diseases

8. Lack of ability or willingness to give informed consent

9. Enrolled in any other clinical study within 3 months before enrolment

10. Any people whose life style is irregular, for example, person works at night shifts.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Dietary Supplement:
• D-allulose
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.

Locations

Country	Name	City	State
Thailand	Clinical trial Unit, Faculty of Medicine, Chiang Mai University	Muang	ChiangMai

Sponsors (2)

Lead Sponsor	Collaborator
Chiang Mai University	Kagawa University

Country where clinical trial is conducted

Thailand, 

References & Publications (13)

Chung 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. — View Citation

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. — View Citation

Granström 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. — View Citation

Hayashi 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. Epub 2010 Mar 7. — View Citation

Hossain 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 ß-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. — View Citation

Iida 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. — View Citation

Matsuo 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. Retraction in: J Clin Biochem Nutr. 2014 May;54(3):219. — View Citation

Matsuo 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. Epub 2006 Sep 7. — View Citation

Matsuo 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. — View Citation

Ochiai 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. Epub 2013 May 7. — View Citation

Ochiai 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. — View Citation

Takeshita 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. — View Citation

Wong 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. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The dose-response effects of D-allulose with sucrose beverage on insulin levels after oral sucrose tolerance test	Oral sucrose tolerance test with sucrose +/- allulose	2 hours	Yes
Other	Time to peak plasma insulin concentration	Oral sucrose tolerance test with sucrose +/- allulose	2 hours	Yes
Primary	The dose-response effects of D-allulose (psicose) with sucrose beverage on glucose tolerance	oral sucrose tolerance test with sucrose +/- allulose	2 hours	Yes
Secondary	Time to peak plasma glucose concentration	oral sucrose tolerance test with sucrose +/- allulose	2 hours	Yes