To investigate if the active product shows a postprandial plasma triglyceride profile different from the control product in healthy adult male volunteers.
ID
Source
Brief title
Condition
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Plasma triglyceride concentrations
Secondary outcome
Concentrations of free fatty acids, lipoproteins, glucose, insuline, amino
acids and satiety hormones.
Background summary
Breast milk is considered the gold standard of infant nutrition and differs
from infant milk formula with respect to their fat globules. Breast milk
contains larger fat globules which are coated by a phospholipid membrane, while
milk proteins adhere to and cover the surface of fat globules in infant milk
formula. The size and composition of these fat globules may have a beneficial
effect on fat handling of the body. Nutricia Research has developed a milk
formula with fat globules that resemble the fat globules present in breast
milk. Research performed in animals provide strong arguments for the hypothesis
that the size and composition of fat globules in nutrition affects digestion,
absorption and plasma lipid compounds.
Study objective
To investigate if the active product shows a postprandial plasma triglyceride
profile different from the control product in healthy adult male volunteers.
Study design
A randomised, double blind, cross-over study, which will consist of a screening
and two testing days with 1 week wash-out in between. During the testing day,
blood will be samples through an intravenous canula and subjects will be
provided with a breakfast and a lunch.
Intervention
Subjects will be provided with two different milk powders dissolved in 400 mL
water. These products are available in the supermarket or produced by Nutricia
Research, and they are safe for human consumption.The content of protein,
carbohydrates and fats is similar between the products, only the size and
composition of the fat globules differs.
Study burden and risks
Subjects are screened for eligibility. During this screening visit, height,
weight, waist circumference and blood pressure are determined. Subjects will
also fill-out two questionnaires. During the study, subjects will come to the
university twice for a testing dat of 5 hours. During this day, an intravenous
canula is placed and blood will be sampled on 10 occasions. In addition,
expired air is sampled on 6 time points and subjects will fill out satiety
questionnaires on 6 time points. During the first testing day, subjects will
also fill out a food frequency questionnaire.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
Inclusion criteria
- Healthy, adult, male, Caucasian, Dutch-speaking subjects
- Non-smokers
- Lactose- and milk-tolerant
- Age 18-25 yr
- Body Mass Index (BMI) of 20-25 kg/m2
- Girth width <100 cm
- Stable body weight (weight gain or loss < 2 kg in the past three months)
- Willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study, during the study, and 4 weeks after the study (i.e. after the follow-up phone call)
- Written informed consent
Exclusion criteria
- Top sports men or athletes with a daily strenuous training program (>2 hr)
- Known diseases or malfunctions e.g. fat malabsorption, gastrointestinal malformations, haemophilia, hepatitis B, human immunodeficiency virus (HIV), high blood-pressure, hyperlipidaemia or diabetes
- Current illnesses which could interfere with the study (e.g. prolonged severe diarrhoea, regurgitation, severe flu): to be determined on judgement of the investigator
- Medication use (except for paracetamol) or a medically prescribed diet
- More than 21 alcoholic consumptions per week
- Use of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters during the study and 2 weeks in advance of study start
- Any current participation, or participation within 8 weeks before study start, in any other study involving investigational or marketed products
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements and instructions
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46908.068.13 |