NCT02455934

Brief 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. 1.Sucrose 50 g
  2. 2.Sucrose 50 g + D-allulose (psicose) 2.5 g
  3. 3.Sucrose 50 g + D-allulose (psicose) 5 g
  4. 4.Sucrose 50 g + D-allulose (psicose) 7.5 g
  5. 5.Sucrose 50 g + D-allulose (psicose) 10 g
  6. 6.To investigate the dose-response effects of D- allulose (psicose) with sucrose beverage on glucose tolerance
  7. 7.To investigate the dose-response effects of D- allulose (psicose) with sucrose beverage on insulin levels

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 2, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

February 23, 2015

Last Update Submit

January 30, 2016

Conditions

Impaired Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

  • The dose-response effects of D-allulose (psicose) with sucrose beverage on glucose tolerance

    oral sucrose tolerance test with sucrose +/- allulose

    2 hours

Secondary Outcomes (1)

  • Time to peak plasma glucose concentration

    2 hours

Other Outcomes (2)

  • The dose-response effects of D-allulose with sucrose beverage on insulin levels after oral sucrose tolerance test

    2 hours

  • Time to peak plasma insulin concentration

    2 hours

Study Arms (5)

Sucrose

PLACEBO COMPARATOR

Sucrose 50 g

Dietary Supplement: D-allulose

SAlloulose2.5

ACTIVE COMPARATOR

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

Dietary Supplement: D-allulose

SAllulose5

ACTIVE COMPARATOR

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

Dietary Supplement: D-allulose

SAllulose7.5

ACTIVE COMPARATOR

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

Dietary Supplement: D-allulose

SAllulose10

ACTIVE COMPARATOR

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

Dietary Supplement: D-allulose

Interventions

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.

SAlloulose2.5SAllulose10SAllulose5SAllulose7.5Sucrose

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical trial Unit, Faculty of Medicine, Chiang Mai University

Muang, ChiangMai, 50200, Thailand

Location

Related Publications (13)

  • 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.

    PMID: 4299740BACKGROUND

  • 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. doi: 10.1016/s1389-1723(01)80018-9.

    PMID: 16232889BACKGROUND

  • Granstrom 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.

    PMID: 16233597BACKGROUND

  • 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. doi: 10.3177/jnsv.48.77.

    PMID: 12026195BACKGROUND

  • 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.

    PMID: 19794929BACKGROUND

  • 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. doi: 10.3177/jnsv.54.511.

    PMID: 19155592BACKGROUND

  • 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. doi: 10.1271/bbb.90707. Epub 2010 Mar 7.

    PMID: 20208358BACKGROUND

  • 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 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.

    PMID: 22877751BACKGROUND

  • 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.

    PMID: 24144428BACKGROUND

  • 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. doi: 10.1271/bbb.60036. Epub 2006 Sep 7.

    PMID: 16960391BACKGROUND

  • 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. doi: 10.1271/bbb.130019. Epub 2013 May 7.

    PMID: 23649241BACKGROUND

  • 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.

    PMID: 22339545BACKGROUND

  • 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. doi: 10.1097/00004836-200603000-00015.

    PMID: 16633129BACKGROUND

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Supawan Buranapin, MD

    Chiang Mai University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor Supawan Buranapin, MD

Study Record Dates

First Submitted

February 23, 2015

First Posted

May 28, 2015

Study Start

April 1, 2015

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

February 2, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)