To determine the mass balans after ingestion of a single dose of tagatose, a low-glycaemic sugar, in healthy volunteers.
ID
Source
Brief title
Condition
- Other condition
- Appetite and general nutritional disorders
Synonym
Health condition
Metabolisme
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
72h mass balance following 14C-tagatose ingestion.
Secondary outcome
Secondary endpoints: content of 14C-labelled metabolites in carbohydrate
metabolism pathways, whole-body substrate (carbohydrate and lipid) oxidation.
Background summary
Worldwide almost 40% of the adult population is overweight (including >10%
obese), and more than 350 million children (up to the age of 19) are
overweight. This causes severe problems, socially, psychologically but also
medically, where people may have an increased risk for various life-threatening
diseases. The caloric value of carbohydrates is an important parameter in our
daily nutrition. In the battle against overweight, it is of key to understand
which nutrition contributes to what extent in caloric intake. The caloric
intake is calculated based on the energy in covalent bonds and the assumption
that all energy is absorbed and used by the body. However, this often
overestimates the caloric value of a compound. A low-glycaemic sugar, i.e.
tagatose, has been developed to support weight management, yet its true caloric
value is currently unknown.
Study objective
To determine the mass balans after ingestion of a single dose of tagatose, a
low-glycaemic sugar, in healthy volunteers.
Study design
Single group design
Intervention
A single test day during which participants will orally ingest a dietary
supplement containing 14C-labelled tagatose, followed by a 72-hour test period
during which all urine and faeces will be collected, as well as repeated
sampling of blood and expired air, as well as indirect calorimetry
measurements.
Study burden and risks
Insertion of the catheters in a vein is comparable to a normal blood draw and
the only risk is a small local hematoma. Tagatose ingestion might lead to
gastro-intestinal discomfort. During the run-in period participants will
consume commercially available Bomunose, which is safe for human consumption.
The radioactive labelled tagatose that will be consumed orally on the test day
is produced under sterile conditions according to GMP standards and completely
safe for human consumption.
De Elst 1
Wageningen 6708 WD
NL
De Elst 1
Wageningen 6708 WD
NL
Listed location countries
Age
Inclusion criteria
- 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)
Exclusion criteria
- 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL84060.028.23 |