CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Allulose +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02459834
NCT02459834N/ACompleted

An Acute Randomized Dose-finding Equivalence Trial of Small, Catalytic Doses of Fructose and Allulose on Postprandial Carbohydrate Metabolism: The Fructose and Allulose Catalytic Effects (FACE) Study

University of Toronto·interventional·Posted Jun 2, 2015·Updated Aug 8, 2017

In Brief

A clinical study evaluating Allulose, Fructose, and 1 other intervention for Type 2 Diabetes. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Diabetes remains one of the most important unmet prevention and treatment challenges, and the prevalence of diabetes continues to grow. Some functional food ingredients may hold promise as potential therapies for diabetes. One such functional food is allulose, which is a c-3 epimer of fructose. Allulose is a non-caloric sugar found naturally in small amounts in foods such as dried fruits, brown sugar and maple syrup. Previous research has found that catalytic doses of fructose and allulose have been shown to decrease the postprandial glycemic responses to high glycemic index meals. Fructose, in exchange for other carbohydrates, has also been found to decrease HbA1c levels. Whether the effects of fructose and allulose are equivalent is of particular interest, as allulose represents a non-caloric alternative to fructose. The minimum 'catalytic' dose at which improvements in carbohydrate metabolism are observed also remains to be determined for each of the sugars in people with and without diabetes. This study is an acute randomized controlled dose-finding equivalence trial to assess the effect of fructose and allulose at 2 dose levels (5g and 10g) compared with control (0g) on the glucose and insulin responses to a 75g oral glucose tolerance test (OGTT) in healthy and type 2 diabetes participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesCanada
CollaboratorsTate & Lyle

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2, 2015
Enrollment StartNov 1, 2015
Primary CompletionAug 1, 2016
TodayJul 1, 2026
Enrollment to primary: 9 monthsPosted 11.1 years ago

Interventions

Alluloseother

A double-blind, randomized, multiple-crossover "equivalence" design. Each participant will act as their own control receiving the treatments in random order, each separated by a 1 week washout period. The treatment will be developed by Tate \& Lyle.

Fructoseother

A double-blind, randomized, multiple-crossover "equivalence" design. Each participant will act as their own control receiving the treatments in random order, each separated by a 1 week washout period. The treatment will be developed by Tate \& Lyle.

Controlother

A double-blind, randomized, multiple-crossover "equivalence" design. Each participant will act as their own control receiving the treatments in random order, each separated by a 1 week washout period. The treatment will be developed by Tate \& Lyle.