An Open-Label, Non-Randomised Study to Assess Calorific Value and Mass Balance of Orally Administered [14C]-labeled test product in Healthy Adult Subjects Using a Microtracer Approach

1.Healthy males or healthy females of non-childbearing potential
2.Age 18 to 65 years of age at the time of signing informed consent
3.Body mass index (BMI) of 18.0 to 29.9 kg/m2 (inclusive)
4.Must be willing and able to communicate and participate in the whole study, including
consumption of allulose and meals offered during study conduct
5.Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools
per day)
6.Must understand the requirements of the study and provide written informed consent
7.Must agree to adhere to the contraception requirements defined
8.Must usually eat 3 meals per day (ie breakfast, lunch and dinner)
9.Must be affiliated to a social security scheme (ie have a National Insurance number)

1.Subjects who have received any investigational medicinal product in a clinical
research study within the 90 days prior to Day 1
2.Subjects who are study site employees, or immediate family members of a study site
or sponsor employee
3.History of any drug or alcohol abuse in the past 2 years
4.Regular alcohol consumption in males >21 units per week and females >14 units per
week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL
glass of wine, depending on type)
5.A confirmed positive alcohol breath test at screening or admission
6.Current smokers and those who have smoked within the last 6 months. A confirmed
breath carbon monoxide reading of greater than 10 ppm at screening or admission
7.Current users of e-cigarettes and nicotine replacement products and those who have
used these products within the last 6 months
8.Females of childbearing potential including those who are pregnant or lactating (all
female subjects must have a negative urine pregnancy test). A woman is considered
of childbearing potential unless she is permanently sterile (hysterectomy, bilateral
salpingectomy and bilateral oophorectomy), surgically sterilised (by tubal ligation or
equivalent) or is postmenopausal (had no menses for 12 months without an
alternative medical cause and a serum follicle-stimulating hormone [FSH]
concentration ≥40 IU/L)
9.Radiation exposure, including that from the present study, excluding background
radiation but including diagnostic x-rays and other medical exposures, exceeding
5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed
worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the
study
10.Subjects who have been enrolled in an absorption, distribution, metabolism and
excretion (ADME) study in the last 12 months prior to [14C]-allulose administration
11.Subjects who do not have suitable veins for multiple venepunctures/cannulation as
assessed by the investigator or delegate at screening
12.Clinically significant abnormal biochemistry, haematology or urinalysis as judged by
the investigator
13.Positive drugs of abuse test result or alcohol breath test at screening or admission
14.Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or
human immunodeficiency virus (HIV) results
15.Evidence of renal impairment at screening, as indicated by an estimated creatinine
clearance of <90 mL/min using the Cockcroft-Gault equation
16.History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or
gastrointestinal disease, immunodeficiency, endocrine, neurological or psychiatric
disorder, as judged by the investigator
17.Subjects who have claustrophobia
18.Subjects who are on a weight loss diet or following a high calorific/high protein diet
in order to gain weight.
19.Subjects who have diabetes and/or impaired glucose tolerance
20.Subjects with functional constipation
21.Any known food allergies or intolerances to the 14 major food allergens (celery,
cereals containing gluten, crustaceans, eggs, fish, lupin, milk, molluscs, mustard,
tree nuts, peanuts, sesame seeds, soybeans, sulphur dioxide and sulphites) or
history of a malabsorption syndrome including coeliac disease
22.Subjects who have regular gastrointestinal complaints including abdominal pain,
stomach upsets and borborygmi or known or suspected irritable bowel syndrome
23.Subjects who have liquid stools at least 1 day per week
24.Subjects who have taken antibiotics within the 60 days prior to the adaptation phase
25.Subjects who have taken in the 15 days prior to the adaptation phase, any drugs,
food supplements or any food presented commercially as containing substances,
bacteria or yeasts likely to have an effect on gastrointestinal comfort, in particular on
intestinal transit, flatulence or abdominal pains (eg probiotics, macrobiotics,
L. acidophilus or bifidus bacteria)
26.Subjects who are taking, or have taken, any prescribed or over-the-counter drug
(other than 4 g of paracetamol per day or HRT) or herbal remedies in the 14 days
before first allulose administration (ie the adaptation period).
Exceptions may apply on a case by case basis, if considered not to interfere with the
objectives of the study, as agreed by the PI and sponsor’s medical monitor
27.Subjects following chronic medical treatment, including anti-cholinergic, anti-emetic,
antihistamine, anti-parkinsonian, anti-psychotic, antacid containing aluminium,
analgesic, antagonist H2 receptors, opioid and narcotic, laxative or anti-diarrheal
28.Presence or history of clinically significant allergy requiring treatment, as judged by
the investigator. Hay fever is allowed unless it is active
29.Donation or loss of greater than 400 mL of blood within the previous 3 months
30.Subjects with a high physical and sporting practice (defined as more than 5 h per
week, as assessed using the International Physical Activity Questionnaire [IPAQ]
31.Subjects who are under legal protection or deprived of rights following administrative
or judicial decision
32.Failure to satisfy the investigator of fitness to participate for any other reason