The primary objective of this study is to investigate if the addition of bovine milk fat to an infant-formula product increases the diet-induced thermogenesis. Secondary objectives are to investigate if the addition of bovine milk fat in an infant…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
metabolisme
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameter is the diet-induced thermogenesis (DIT). This will be
measured for five hours after the consumption of the infant formula products.
Secondary outcome
Secondary study parameters are postprandial lipid profile, respiratory exchange
ratio, and triglyceride level, apolipoprotein levels, phospholipid level, fatty
acid profile and chylomicron size, which will all be measured in
chylomicron-rich fraction of plasma. Furthermore, glucose, insulin and satiety
hormone levels will be measured in blood, acetone concentrations in exhaled air
and satiety will further be investigated via questionnaires and caloric intake
at an ad libitum lunch.
Background summary
Because of its favourable triglyceride structure for digestion and absorption,
bovine milk fat is thought to be a good source of lipids for infant formula.
The addition of bovine milk fat also delivers short- and medium-chain fatty
acids, which are not or hardly present in vegetable fat mixtures that are
commonly used. It would be interesting to investigate what the effect of those
fatty acids is on metabolism. Medium-chain triglycerides are known to affect
energy metabolism, since they are easily absorbed and oxidized. It is expected
that the short- and medium-chain fatty acids in bovine milk fat have a similar
effect. The effect of the triglyceride structure of bovine milk fat on
absorption into the blood and the metabolic responses is also not clear. With
this study we would like to investigate whether the addition of bovine milk fat
to infant formula has a different effect on metabolism then a mixture of
vegetable fats only.
Study objective
The primary objective of this study is to investigate if the addition of bovine
milk fat to an infant-formula product increases the diet-induced thermogenesis.
Secondary objectives are to investigate if the addition of bovine milk fat in
an infant formula product influences the: 1) substrate oxidation, 2)
postprandial lipid profile, 3) postprandial triglyceride levels in the
chylomicron-rich fraction of plasma, 4) chylomicron size and composition, 5)
satiety
Study design
This study will be a randomized double-blinded cross-over study which will
consist of two study days.
Intervention
The subjects will receive milkshakes made of infant-formula products containing
two different fat mixtures; one consisting of 100% vegetables fat and one
containing 65% bovine milk fat and 35% vegetable fats.
Study burden and risks
The risks related to this study are minor for the subjects. The participants
will be asked to come to the university two times. There will also be a
screening visit. On both study days participants will be asked to lie down on
a bed with their head placed under a ventilated hood to perform measurements on
exhaled air. Blood sampling will take place on several time points, therefore
an intravenous cannula will be installed. There is a small risk of bruising and
sore muscles after the blood sampling procedures.
De Elst 1
Wageningen 6708 WD
NL
De Elst 1
Wageningen 6708 WD
NL
Listed location countries
Age
Inclusion criteria
* Caucasian male
* 18-28 years old
* Body mass index (BMI) 20-25 kg/m2.
* Regular consumption of milk (products)
* Haemoglobin (Hb) level > 8.4 mmol/L
Exclusion criteria
* (symptoms of) cow*s milk allergy
* Lactose intolerance
* Metabolic diseases
* (known symptoms of) (auto)immune diseases, like diabetes
* (known symptoms of) gastro-intestinal diseases, like; irritable bowel syndrome
Intestinal malabsorption, diagnosed with celiac disease, Crohn*s disease, colitis ulcerosa, short bowel syndrome or surgical bowel interventions leading to malabsorption;
* Cardiovascular diseases
* Vegetarian/vegan
* Smoking (to be included, subject has to stopped smoking at least 6 months for the start of the study)
* Usage of over the counter drugs, such as antacids and laxatives
* Abuse of drugs
* Consumption of >21 glasses of alcohol per week
* More than 5 hours of strenuous exercise (>6.0 METS) every week
* High level of restraint eating, as determined by the NVE questionnaire (Nederlandse vragenlijst voor eetgedrag)
* Claustrophobia
* Unsuitable veins for blood sampling
* Blood donation during the two months before the start of the study and during the study
* Current participation in other scientific studies
* Employee of Human and Animal Physiology or Human Nutrition or BSc/MSc thesis student at Human and Animal Physiology
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63894.081.17 |
| OMON | NL-OMON27539 |