Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Friesland Campina | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V-A-C | Experimental | Order of administration:
|
|
| V-C-A | Experimental | Order of administration:
|
|
| A-V-C | Experimental | Order of administration:
|
|
| A-C-V | Experimental | Order of administration:
|
|
| C-A-V | Experimental | Order of administration:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100% vegetable blend | Other | Dietary lipid challenge test: 600 ml skimmed milk plus 95 gram of vegetable fat blend. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in transcriptomics from baseline to 6 hours after consumption of the three different fat blends, to elucidate underlying mechanistic responses in the circulation. | By using untargeted whole genome Affymetrix microarray the investigators will measure gene expression in isolated monocytes. | Baseline and 6 hours after consumption of the dietary lipid challenge. |
| Change in cytokine concentration from baseline and every hour until 8 hours after consumption of the different fat blends, to elucidate the effect on immune responses in the circulation. | Cytokine concentrations in the circulation will be measured via ELISA. | Baseline and every hour until 8 hours after consumption of the dietary lipid challenge. |
| Change in functional responses to LPS stimulation of isolated monocytes from the circulation from baseline to 6 hours after consumption of the different fat blends. | Cell study with isolated monocytes from the circulation. The cells will be treated with LPS to evaluate functional responses. We will measure fold changes. | Baseline and 6 hours after consumption of the dietary lipid challenge. |
| Change in sensitivity of isolated monocytes from the circulation. | Cell study with isolated monocytes from the circulation. The cells will be treated with different fat loads and inflammatory stimuli to evaluate the sensitivity of the collected monocytes. We will measure fold changes. | Baseline and 6 hours after consumption of the dietary lipid challenge. |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial triacylglycerol changes | TAG concentration in plasma will be measured in a clinical chemical lab. | Baseline and every hour until 8 hours after consumption of the dietary lipid challenge. |
| Postprandial glucose changes |
| Measure | Description | Time Frame |
|---|---|---|
| Immune cell populations | Relative immune cell populations will be determined in whole blood via FACS analysis. | Baseline and 6 hours after consumption of the dietary lipid challenge. |
| CRP | The CRP value of each research subject will be determined by using a QuikRead CRP test. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlotte Michielsen, MSc | Contact | +31 317 484 864 | charlotte.michielsen@wur.nl | |
| Lydia Afman, PhD | Contact | +31 317 485 789 | lydia.afman@wur.nl |
| Name | Affiliation | Role |
|---|---|---|
| Lydia Afman, PhD | Wageningen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wageningen University, Division of Human Nutrition | Recruiting | Wageningen | Gelderland | 6700 EV | Netherlands |
Collected data will be coded.
Not provided
Not provided
Not provided
Not provided
Not provided
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. All research subjects have consumed all three dietary lipid challenge tests at the end of the study.
Not provided
Not provided
Not provided
|
| C-V-A | Experimental | Order of administration:
|
|
| 100% AMF | Other | Dietary lipid challenge test: 600 ml skimmed milk plus 95 gram of anhydrous milk fat. |
|
| 100% cream | Other | Dietary lipid challenge test: 600 ml skimmed milk plus 95 gram of anhydrous milk fat plus milk fat globular membranes. |
|
Cardio-metabolic markers such as glucose (mg/dl) will be measured in the circulation.
| Baseline and every hour until 8 hours after consumption of the dietary lipid challenge. |
| Postprandial adiponectin changes | Cardio-metabolic markers such as adiponectin (pg/ml) will be measured in the circulation. | Baseline and every hour until 8 hours after consumption of the dietary lipid challenge. |
| Postprandial insulin changes | Cardio-metabolic markers such as insulin (mIU/L) will be measured in the circulation. | Baseline and every hour until 8 hours after consumption of the dietary lipid challenge. |
| Postprandial (untargeted) protein profile changes | Using untargeted proteomic platforms, the changes in protein profiles in the circulation will be measured. | Baseline and every hour until 8 hours after consumption of the dietary lipid challenge. |
| Postprandial (targeted) protein profile changes | Using targeted proteomic platforms, the changes in protein profiles in the circulation will be measured. | Baseline and every hour until 8 hours after consumption of the dietary lipid challenge. |
| Postprandial (untargeted) metabolite profile changes | Using untargeted metabolomic platforms, the changes in protein profiles in the circulation will be measured. | Baseline and every hour until 8 hours after consumption of the dietary lipid challenge. |
| Postprandial (targeted) metabolite profile changes | Using targeted metabolomic platforms, the changes in protein profiles in the circulation will be measured. | Baseline and every hour until 8 hours after consumption of the dietary lipid challenge. |
| Postprandial changes in feelings of hunger and satiety | Feelings of hunger and satiety will be measured via a questionnaire using a Visual Analog Scale (VAS), a 100 mm line anchored at each end by descriptors. Research subjects will place a mark on the scale that corresponds to their feelings of hunger and satiety. The distance from the lower end of the scale is then measured and recorded. | Baseline and every hour until 8 hours after consumption of the dietary lipid challenge. |
| Cytokine concentration comparison | Cytokine concentrations in the circulation obtained via catheter cannula will be measured via ELISA. The investigators will also measure cytokine concentrations in dried blood spots obtained via a finger prick (via a Meso Scale Discovery Electrochemiluminescence platform). | Baseline and 6 hours after consumption of the dietary lipid challenge. |
| Before the start of a study day. |
| WHR | Both waist and Hip circumference will be measured using a measuring tape. | Baseline |
| BMI | weight (in kg) and height (in meters) will be measured and combined to report BMI in kg/m^2 | Baseline |
| Habitual intake | As assessed by a validated FFQ. | Baseline |
| Renal or hepatic malfunctioning | ALAT (IU/L), ASAT (IU/L) will be measured in a clinical chemical lab. | Baseline |
| Renal malfunctioning | creatinine (mg/dL) will be measured in a clinical chemical lab. | Baseline |
| Anemia | Hemoglobin will be determined via a finger prick. | Baseline |