NCT02714413

Brief Summary

Individuals in the United States now consume a substantial proportion of their total energy as added sugars. The consumption of caloric sweeteners has been steadily increasing over the last four decades. The potential health consequences of this practice have been subject to considerable debate. In addition to weight gain, higher consumption of sugar-sweetened beverages is associated with development of metabolic syndrome and type 2 diabetes. These findings support the current dietary guidelines that encourage consumers to limit their intake of added sugars. There is a need for a sugar substitute that is safe, palatable and has favorable effects on energy metabolism and overall glucose homeostasis. One such sugar is possibly D-allulose also referred to in the literature as D-psicose. The present proposal is to address the efficacy of D-allulose in reducing postprandial blood glucose level in a random sample of Caucasian and African American population. Specifically the effect of D-allulose ingestion on the glucose and insulin response to a standardized oral glucose load will be studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_2

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

March 8, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

March 8, 2016

Last Update Submit

July 7, 2017

Conditions

Blood Glucose

Keywords

D-alluloseCaucasianAfrican American

Outcome Measures

Primary Outcomes (1)

  • Plasma glucose (mg/dL)

    Evaluation of the efficacy of pure D-allulose on the glycemic excursion following a standard oral sucrose load.

    120 minutes

Secondary Outcomes (1)

  • Serum insulin

    120 minutes

Study Arms (5)

Sucrose 50g + placebo

PLACEBO COMPARATOR

All the test sugars will be dissolved in 300 ml water to be consumed within 10 minutes

Dietary Supplement: sucroseOther: Placebo

Sucrose 50g + D-allulose 2.5 g

EXPERIMENTAL

All the test sugars will be dissolved in 300 ml water to be consumed within 10 minutes

Dietary Supplement: D-alluloseDietary Supplement: sucrose

Sucrose 50g + D-allulose 5.0 g

EXPERIMENTAL

All the test sugars will be dissolved in 300 ml water to be consumed within 10 minutes

Dietary Supplement: D-alluloseDietary Supplement: sucrose

Sucrose 50g + D-allulose 7.5 g

EXPERIMENTAL

All the test sugars will be dissolved in 300 ml water to be consumed within 10 minutes

Dietary Supplement: D-alluloseDietary Supplement: sucrose

Sucrose 50g + D-allulose10.0 g

EXPERIMENTAL

All the test sugars will be dissolved in 300 ml water to be consumed within 10 minutes

Dietary Supplement: D-alluloseDietary Supplement: sucrose

Interventions

D-alluloseDIETARY_SUPPLEMENT

Subjects will be their own controls as they will be studied sequentially for the effects of varying amounts of D-allulose given in a random order associated with standardized oral sucrose load of 50 gms. In order to limit the possibility of carry-over effect, patients will be randomized to different treatment sequences. In each sequence all four doses (2.5, 5, 7.5, and 10 gm) and placebo will be present only one time and will be administered in a different order.

Also known as: D-psicose
Sucrose 50g + D-allulose 2.5 gSucrose 50g + D-allulose 5.0 gSucrose 50g + D-allulose 7.5 gSucrose 50g + D-allulose10.0 g
sucroseDIETARY_SUPPLEMENT

All subjects will receive a standardized oral sucrose load of 50 gms

Sucrose 50g + D-allulose 2.5 gSucrose 50g + D-allulose 5.0 gSucrose 50g + D-allulose 7.5 gSucrose 50g + D-allulose10.0 gSucrose 50g + placebo
PlaceboOTHER

Subjects will be their own controls as they will be studied sequentially for the effects of varying amounts of D-allulose given in a random order associated with standardized oral sucrose load of 50 gms. In order to limit the possibility of carry-over effect, patients will be randomized to different treatment sequences. In each sequence all four doses (2.5, 5, 7.5, and 10 gm) and placebo will be present only one time and will be administered in a different order.

Sucrose 50g + placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women 18-70 years of age
  • Have an HbA1C \< 5.8%.
  • Subjects from whom informed consent has been obtained in accordance with University of Florida Institutional Review Board regulations.

You may not qualify if:

  • Pregnancy or lactation
  • Diagnosed with diabetes mellitus
  • Weight change ≥ 5 % within 3 months prior to admission to the study
  • Has taken any weight loss medications within 3 months prior to admission to the study
  • Immunocompromised status, including a debilitated state or malignancy
  • Active liver, renal, thyroid diseases
  • Frequent alcoholic consumption more than twice a week; with beer \> 360 mL, alcohol \> 45 mL, wine \> 150 mL for female, or beer \> 720 mL, whisky \> 90 mL, wine \> 300 mL for male each time
  • Has gastrointestinal symptoms such as nausea, vomiting, loss of appetite, premature satiety, diarrhea, or chronic constipation
  • Lack of ability or willingness to give informed consent
  • Taken any medications than might cause weight loss or weight gain such as corticosteroid, antidepressant, antipsychotics, oral contraceptive pills \< 8 weeks or change the dose of these medication with 8 week prior to admission
  • People with clinical diagnosis of diabetes.
  • Patients in cardiac Class II, III or IV.
  • Patients who have had renal transplants or are currently receiving renal dialysis.
  • Patients with the diagnosis of psychosis.
  • Patients with known HIV infection.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

Location

Related Publications (1)

  • Franchi F, Yaranov DM, Rollini F, Rivas A, Rivas Rios J, Been L, Tani Y, Tokuda M, Iida T, Hayashi N, Angiolillo DJ, Mooradian AD. Effects of D-allulose on glucose tolerance and insulin response to a standard oral sucrose load: results of a prospective, randomized, crossover study. BMJ Open Diabetes Res Care. 2021 Feb;9(1):e001939. doi: 10.1136/bmjdrc-2020-001939.

    PMID: 33637605DERIVED

MeSH Terms

Interventions

psicoseSucrose

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Dominick J Angiolillo, MD, PhD

    University of Florida College of Medicine-Jacksonville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2016

First Posted

March 21, 2016

Study Start

August 1, 2016

Primary Completion

March 10, 2017

Study Completion

June 30, 2017

Last Updated

July 11, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)