Nutrition Clinical Trial
— POEMIOfficial 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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | February 28, 2020 |
Est. primary completion date | February 28, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility |
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 illicit drugs - Food allergies for products that the investigators 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Wageningen University, Division of Human Nutrition | Wageningen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Wageningen University | Friesland Campina |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | |
Other | CRP | The CRP value of each research subject will be determined by using a QuikRead CRP test. | Before the start of a study day. | |
Other | WHR | Both waist and Hip circumference will be measured using a measuring tape. | Baseline | |
Other | BMI | weight (in kg) and height (in meters) will be measured and combined to report BMI in kg/m^2 | Baseline | |
Other | Habitual intake | As assessed by a validated FFQ. | Baseline | |
Other | Renal or hepatic malfunctioning | ALAT (IU/L), ASAT (IU/L) will be measured in a clinical chemical lab. | Baseline | |
Other | Renal malfunctioning | creatinine (mg/dL) will be measured in a clinical chemical lab. | Baseline | |
Other | Anemia | Hemoglobin will be determined via a finger prick. | Baseline | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Secondary | 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. | |
Secondary | Postprandial glucose changes | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Recruiting |
NCT05867433 -
Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments
|
N/A | |
Completed |
NCT02376530 -
Price Changes and Nutrient Profiling Among Adult Grocery Shoppers
|
N/A | |
Completed |
NCT00957814 -
Nutritional Orientations and Adherence, Nutritional Status, Clinical and Life Quality Parameters of Heart Failure (HF) Patients
|
N/A | |
Completed |
NCT01040975 -
Teen CHAT: Improving Physician Communication With Adolescents About Healthy Weight
|
N/A | |
Completed |
NCT00808756 -
Study on Fermentable Carbohydrates in Healthy Infants
|
N/A | |
Completed |
NCT03290118 -
The Efficacy of Front-of-package Labelling Schemes: an Experimental Study
|
N/A | |
Completed |
NCT03575884 -
Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers
|
N/A | |
Completed |
NCT03963778 -
Organisational Culture and Nutritional Care
|
||
Completed |
NCT05633251 -
Using Reinforcement Schedules to Increase Fruit&Vegetable Intake, Reduce Waste, and Increase School Lunch Participation
|
N/A | |
Recruiting |
NCT05977959 -
Optimizing the Impact of the Healthy School Recognized Campus Program on Youth's CVD Risk Factors
|
N/A | |
Recruiting |
NCT05138276 -
Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates
|
Early Phase 1 | |
Completed |
NCT03906851 -
Active and Healthy Kids in Telemark - a School Based Health Promoting Intervention
|
N/A | |
Not yet recruiting |
NCT02950779 -
Assessment of Handgrip Strength in Adults With Inflammatory Bowel Disease
|
N/A | |
Completed |
NCT02486588 -
Increasing Engagement With a Healthy Food Benefit
|
N/A | |
Withdrawn |
NCT01184027 -
Impact of Nutrition and Swallowing Function of Head and Neck Cancer Patients During the Course of Treatment
|
N/A | |
Completed |
NCT01178398 -
Understanding Fish Consumption Habits During Pregnancy
|
N/A | |
Completed |
NCT01249508 -
Nutrition Labeling Program to Promote Healthy Dietary Patterns
|
N/A | |
Terminated |
NCT00577499 -
Effect of Lubiprostone on Nutritional Status and Pulmonary Function in Adults With Cystic Fibrosis
|
N/A | |
Completed |
NCT00109551 -
Community Trial of Zinc Supplementation on Preschool Child Mortality and Morbidity in Southern Nepal
|
Phase 3 |