None listed
Conditions
Interventions
10 days intake of test product, of which 1 day 14C-labeled test product
Sponsors
TNO on behalf of industry
Eligibility
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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 hav
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| caloric value of the test product | — |
Secondary
| Measure | Time frame |
|---|---|
| adsorption and metabolism of test product mass balance of test product routes and rates of elimination of test product in urine, feces and expired air characterize metabolite profiles of test product in urine, feces and plasma | — |
Contacts
Public ContactRianne de Ligt
TNO
Outcome results
None listed