The Effects of Different Fat Structures on Postprandial Responses in Healthy Subjects
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
V-A-C
Order of administration:
- 100% vegetable fat blend
- 100% Anhydrous Milk Fat (AMF)
- 100% Cream (AMF + milk fat globular membranes)
干预措施: 100% vegetable blend (Other)
V-A-C
Order of administration:
- 100% vegetable fat blend
- 100% Anhydrous Milk Fat (AMF)
- 100% Cream (AMF + milk fat globular membranes)
干预措施: 100% AMF (Other)
A-V-C
Order of administration:
- 100% Anhydrous Milk Fat (AMF)
- 100% vegetable fat blend
- 100% Cream (AMF + milk fat globular membranes)
干预措施: 100% AMF (Other)
V-A-C
Order of administration:
- 100% vegetable fat blend
- 100% Anhydrous Milk Fat (AMF)
- 100% Cream (AMF + milk fat globular membranes)
干预措施: 100% cream (Other)
V-C-A
Order of administration:
- 100% vegetable fat blend
- 100% Cream (AMF + milk fat globular membranes)
- 100% Anhydrous Milk Fat (AMF)
干预措施: 100% vegetable blend (Other)
V-C-A
Order of administration:
- 100% vegetable fat blend
- 100% Cream (AMF + milk fat globular membranes)
- 100% Anhydrous Milk Fat (AMF)
干预措施: 100% AMF (Other)
V-C-A
Order of administration:
- 100% vegetable fat blend
- 100% Cream (AMF + milk fat globular membranes)
- 100% Anhydrous Milk Fat (AMF)
干预措施: 100% cream (Other)
A-V-C
Order of administration:
- 100% Anhydrous Milk Fat (AMF)
- 100% vegetable fat blend
- 100% Cream (AMF + milk fat globular membranes)
干预措施: 100% vegetable blend (Other)
A-V-C
Order of administration:
- 100% Anhydrous Milk Fat (AMF)
- 100% vegetable fat blend
- 100% Cream (AMF + milk fat globular membranes)
干预措施: 100% cream (Other)
A-C-V
Order of administration:
- 100% Anhydrous Milk Fat (AMF)
- 100% Cream (AMF + milk fat globular membranes)
- 100% vegetable fat blend
干预措施: 100% vegetable blend (Other)
A-C-V
Order of administration:
- 100% Anhydrous Milk Fat (AMF)
- 100% Cream (AMF + milk fat globular membranes)
- 100% vegetable fat blend
干预措施: 100% AMF (Other)
A-C-V
Order of administration:
- 100% Anhydrous Milk Fat (AMF)
- 100% Cream (AMF + milk fat globular membranes)
- 100% vegetable fat blend
干预措施: 100% cream (Other)
C-A-V
Order of administration:
- 100% Cream (AMF + milk fat globular membranes)
- 100% Anhydrous Milk Fat (AMF)
- 100% vegetable fat blend
干预措施: 100% vegetable blend (Other)
C-A-V
Order of administration:
- 100% Cream (AMF + milk fat globular membranes)
- 100% Anhydrous Milk Fat (AMF)
- 100% vegetable fat blend
干预措施: 100% AMF (Other)
C-A-V
Order of administration:
- 100% Cream (AMF + milk fat globular membranes)
- 100% Anhydrous Milk Fat (AMF)
- 100% vegetable fat blend
干预措施: 100% cream (Other)
C-V-A
Order of administration:
- 100% Cream (AMF + milk fat globular membranes)
- 100% vegetable fat blend
- 100% Anhydrous Milk Fat (AMF)
干预措施: 100% vegetable blend (Other)
C-V-A
Order of administration:
- 100% Cream (AMF + milk fat globular membranes)
- 100% vegetable fat blend
- 100% Anhydrous Milk Fat (AMF)
干预措施: 100% AMF (Other)
C-V-A
Order of administration:
- 100% Cream (AMF + milk fat globular membranes)
- 100% vegetable fat blend
- 100% Anhydrous Milk Fat (AMF)
干预措施: 100% cream (Other)
结局指标
主要结局
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.
时间窗: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Cytokine concentrations in the circulation will be measured via ELISA.
Change in transcriptomics from baseline to 6 hours after consumption of the three different fat blends, to elucidate underlying mechanistic responses in the circulation.
时间窗: Baseline and 6 hours after consumption of the dietary lipid challenge.
By using untargeted whole genome Affymetrix microarray the investigators will measure gene expression in isolated monocytes.
Change in sensitivity of isolated monocytes from the circulation.
时间窗: Baseline and 6 hours after consumption of the dietary lipid challenge.
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.
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.
时间窗: Baseline and 6 hours after consumption of the dietary lipid challenge.
Cell study with isolated monocytes from the circulation. The cells will be treated with LPS to evaluate functional responses. We will measure fold changes.
次要结局
- Postprandial glucose changes(Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.)
- Postprandial adiponectin changes(Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.)
- Postprandial changes in feelings of hunger and satiety(Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.)
- Postprandial insulin changes(Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.)
- Postprandial (targeted) protein profile changes(Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.)
- Postprandial (untargeted) protein profile changes(Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.)
- Postprandial triacylglycerol changes(Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.)
- Postprandial (untargeted) metabolite profile changes(Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.)
- Postprandial (targeted) metabolite profile changes(Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.)
- Cytokine concentration comparison(Baseline and 6 hours after consumption of the dietary lipid challenge.)
研究者
Lydia A. Afman
Principal Investigator
Wageningen University
