Assessment of Mass Balance of Orally Administered [14C] Tagatose in Healthy Volunteers Using a Microtracer Approach
- Conditions
- MetabolismeObesityOverweight10003018
- Registration Number
- NL-OMON53253
- Lead Sponsor
- Wageningen Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 8
- 18-65 years old healthy female and male using contraception during and for 3
months after the study
- BMI 18.5-25 kg/m2
- Must be willing and able to communicate and participate in the whole study,
including consumption of tagatose and meals offered during study conduct
- Must have regular bowel movements (i.e. average stool production of >=1 and <=3
stools per day)Must usually eat 3 meals per day (i.e. breakfast, lunch and
dinner)
- Diabetes (Type 1, Type 2, or genetic form of diabetes) - Any diagnosed
cardiovascular (heart) disease or high blood pressure (>=140 mmHg systolic
and/or >=90 mmHg diastolic) - History of clinically significant cardiovascular,
renal, hepatic, chronic respiratory or gastro-intestinal disease,
immunodeficiency, endocrine, neurological or psychiatric disorders - Any
diagnosed respiratory disease, such as COPD or asthma - Any previous motor
disorders or disorders in muscle and/or lipid metabolism - Known severe kidney
problems - Presence of an ulcer in the stomach or gut and/or strong history of
indigestion - Recent or chronic history of diarrhoea - Known anaemia - A
personal or family history of thrombosis (clots), epilepsy, seizures, or
schizophrenia. - Regular use of dietary supplements (>3 times per week) -
Chronic use of any prescribed or over the counter pharmaceuticals (excluding
oral contraceptives and contraceptive devices)History of any drug or alcohol
abuse in the past two years - A confirmed positive alcohol breath test at
screening or admission - Drug use - Claustrophobia - Subjects who are on a
weight loss diet or following a high calorific/high protein diet in order to
gain weight - Subjects with functional constipation - 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 - Subjects who have regular
gastrointestinal complaints including abdominal pain, stomach upsets and
borborygmi or known or suspected irritable bowel syndrome - Currently taking
part in other scientific research - Having received a product with 14C in the
past 12 months - Pregnant or breastfeeding - Smoking or having used
nicotin-containing products in the 6 months prior to the study. - Subjects who
have taken antibiotics within the 60 days prior to the adaptation period. -
Currently involved in a structured progressive resistance training programme
(>3 times per week) - Sedentary lifestyle as assessed using the International
Physical Activity Questionnaire [IPAQ]. - Employed or undertaking a thesis or
internship at the department of Human and Animal Physiology - Unable to give
consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>72h mass balance following 14C-tagatose ingestion. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints: content of 14C-labelled metabolites in carbohydrate<br /><br>metabolism pathways, whole-body substrate (carbohydrate and lipid) oxidation.</p><br>