Nutrition Clinical Trial
Official title:
The Effects of Different Fat Structures on Postprandial Responses in Healthy Subjects
Nowadays, mostly vegetable fat blends are used in infant formula, but the use of bovine milk fat is increasing. In terms of fat structure, bovine milk fat and vegetable fats differ. Bovine milk fat has a higher percentage of palmitic acid attached to the sn-2 position of the glycerol backbone compared to vegetable fat blend. Also bovine milk fat contains milk fat globular membranes, as opposed to vegetable fat. With this study the investigators want to examine the effects of a vegetable fat blend versus bovine milk fat without globular membranes and bovine milk fat with globular membranes on underlying mechanistic, immune and metabolic responses.
Rationale: Human milk is considered as the ideal food for full-term infants. The composition
and function of human milk is unique and has provided the basis for the development of modern
artificial milk formulas that mimic its complex biological positive effects on infants and
can provide an appropriate substitute for non-breastfed infants. An important component in
human milk are the lipids, as they deliver 50% of the total energy to infants. Nowadays,
mostly vegetable fat blends are used in infant formula, but the use of bovine milk fat is
increasing. In terms of fat structure, bovine milk fat and vegetable fats differ. Bovine milk
fat has a higher percentage of palmitic acid attached to the sn-2 position of the glycerol
backbone compared to vegetable fat blend. Also bovine milk fat contains milk fat globular
membranes, as opposed to vegetable fat. Knowledge on how these differences influence
underlying mechanistic, immune and metabolic responses is lacking.
Objectives: The primary objective of this study is to determine the effect of three different
fat blends on underlying mechanistic and immune responses in the circulation. The secondary
objectives of this study are: 1) to examine the effects of the three different fat blends on
postprandial triglyceride concentration and other cardio-metabolic markers in the
circulation, 2) to investigate the effect of the three different fat blends on postprandial
feelings of hunger and satiety, and 3) to investigate how comparable cytokine measurements
are in blood samples obtained via a catheter cannula compared to cytokine measurements in
dried blood spots obtained via a finger prick.
Study design: The POEMI Study is a double‐blind randomized cross‐over acute intervention
study in which each research subject will visit the university on three separate occasions
with a wash-out period of at least one week. At each visit the research subject will undergo
one of the three dietary lipid challenge tests (a shake) in a randomized order. On each study
day research subjects will be asked to clock in 30 minutes prior to the first data collection
points and a catheter cannula will be inserted in a antecubital vein. After the 30 minute
rest, blood will be drawn from the catheter cannula and via a finger prick (baseline
measurements, t0). After the baseline measurements, the research subjects will have to
consume the shake within a time frame of 10 minutes. Blood is again drawn from the catheter
cannula at t= 1, 2, 3, 4, 5, 6, 7, and 8 hours after consumption, with an additional finger
prick at t=6. A questionnaire on hunger and satiety feelings will be taken after every blood
draw.
Study population: The base population will consist of 40 healthy men and women with a BMI
ranging from 22 to 27 kg/m2, aged 40 to 70 years old, selected from the surroundings of
Wageningen through the mailing list for potential study research subjects of the division of
Human Nutrition and health of Wageningen University. If needed, additional recruitment of
research subjects will take place by flyers and posters, or advertisements in local
newspapers.
Intervention: The dietary lipid challenge tests will be provided in the form of a liquid
shake (0.6 L). Each shake will contain 95 gram of fat. The three types of fat that will be
tested include: a) 100% vegetable fat blend, b) 100% Anhydrous milk fat (AMF), c) 100% cream
(AMF + milk fat globular membranes).
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