Study to assess total calorific value of 14C-allulose (QSC117995)
Research type
Research Study
Full title
An Open-Label, Non-Randomised Study to Assess Calorific Value and Mass Balance of Orally Administered [14C]-Allulose in Healthy Adult Subjects Using a Microtracer Approach
IRAS ID
266652
Contact name
Minsun Kim
Contact email
Sponsor organisation
CJ-Tereos
Duration of Study in the UK
0 years, 2 months, 2 days
Research summary
The Sponsor is developing the food ingredient, allulose. As allulose has almost no calorific value, it is proposed to be used as direct replacement for sugars. Foods containing allulose are intended for consumption by the general population seeking products with a reduced sugar content.\n\nThe purpose of this study is to assess the calorific value of allulose (how much energy it contains) and also to show how it is taken up, broken down and removed by the body. This will be done by giving allulose as a radiolabelled liquid to swallow. \n\nThe study will consist of 3 cohorts of 4 healthy male and female volunteers (12 volunteers in total), who will attend the clinical unit for a single study period. At this period, each volunteer will receive a 10 g dose of [14C]-allulose to swallow on Day 1, followed by a further 10 g dose of unlabelled allulose on study days 2 and 3. \n\nPrior to admission to the clinical unit, there will be a 7-day adaptation phase. During this phase 16 volunteers, split into 3 cohorts, will be enrolled to receive 7 once daily doses of 10 g unlabelled allulose in the fed state. The first dose will be given at the clinical unit (on Day-7), subsequent doses (Days -6 to -1) will be self-administered at home. After the adaptation phase, the 4 subjects from each cohort with the highest level of allulose compliance will be admitted to the clinical unit to take part in the study.\n\nVolunteers will remain in the clinical unit for 72 h post [14C]-labelled dose (Day 4), and once discharged will be required to provide home collections of urine until Day 6.\n\nA follow up phone call will take place 4 to 7 days post-discharge to ensure the ongoing wellbeing of the subjects.\n\n
REC name
South Central - Oxford C Research Ethics Committee
REC reference
19/SC/0452
Date of REC Opinion
6 Sep 2019
REC opinion
Favourable Opinion