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…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
metabolisme
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) whole genome gene expression changes in isolated monocytes from the
circulation, 2) postprandial changes in cytokine concentrations in the
circulation, and 3) functional responses and sensitivity of the isolated
monocytes from the circulation.
Secondary outcome
1) postprandial triglyceride concentration and other cardio-metabolic markers
in the circulation, 2) postprandial feelings of hunger and satiety, and 3)
changes in cytokine concentrations in the circulation measured in dried blood
spots.
Background summary
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. 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.
Study objective
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 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, we will insert a
catheter cannula in an antecubital vein of the research subject and
subsequently wait 30 minutes before continuing with the measurements. 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.
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).
Study burden and risks
Research subjects that participate in this study, will have to invest a total
of 31 hours. The total amount of blood collected on each test day will be 158.5
ml, plus once 3 ml during the screening, thus in total 478.5 ml. There are
minor risks for the research subjects during the study. Blood sampling can
occasionally cause a local hematoma or bruise and some research subjects may
report pain or mild discomfort. The consumption of the high-fat shakes is not
expected to be associated with any risk, although in rare cases it could lead
to mild gastro-intestinal discomfort. Research subjects will receive ¤300,-
after completion of the study. They will also receive a repayment of made
traveling expenditures (up to 30 km, one way), a meal the night before each of
the three study days, and a meal after each study day.
Stippeneng 4
Wageningen 6708 WE
NL
Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
Inclusion criteria
- Apparently healthy man or woman
- Age 40-70y at the time of recruitment
- BMI of 22-27 kg/m2
- Having a Hb value above 8.4 (men) or 7.4 (women) mmol/L (will be checked at
the screening visit)
- Having veins suitable for blood sampling via a catheter cannula (judged by
study nurse/ medical doctor)
- Having a general practitioner
- Signed informed consent
Exclusion criteria
- Any chronic metabolic, gastrointestinal, inflammatory or chronic disease
(such as diabetes, anaemia, hepatitis, cardiovascular disease)
- History of gastro-intestinal surgery or having (serious) gastro-intestinal
complaints
- Renal or hepatic malfunctioning (pre-diagnosis or determined based on ALAT,
ASAT and creatinine values)
- Use of medication that may influence the study results, such as laxatives,
stomach protectors and drugs that can affect intestinal motility.
- Donated or intend to donate blood from 2 months before the study until the
end of the study
- Reported slimming, medically prescribed or vegan diet
- Unstable body weight (weight gain or loss >5 kg in the past three months)
- Current smokers
- Alcohol on average: more than 2 consumptions/day or more than 14
consumptions/week
- Pregnant, lactating or wishing to become pregnant in the period of the study
(self-reported)
- Use of drugs (soft and/or hard drugs)
- Food allergies for products that we use in the study
- Participation in another clinical trial at the same time, or in the month
preceding the start of this study
- Inability to understand study information and/or communicate with staff
- Members of the research team
- Working, or doing an internship or thesis at the division *Human Nutrition
and Health*, Wageningen University
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 | NL69492.081.19 |