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Effect of D-allulose in Addition to Oral Sucrose Load

NCT02714413 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-07-11

No results posted yet for this study

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.

Conditions

  • Blood Glucose

Interventions

DIETARY_SUPPLEMENT

D-allulose

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.

DIETARY_SUPPLEMENT

sucrose

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

OTHER

Placebo

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.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Dominick J Angiolillo, MD, PhD · University of Florida College of Medicine-Jacksonville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-03-10
Completion
2017-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02714413 on ClinicalTrials.gov