Postprandial Effects of Milk Fats

NCT04178681 | Unknown

• 1 other identifier: NL69492.081.19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Genomics; Postprandial Metabolism; Nutrition; Metabolism

Keywords

Humans; Milk fat; Clinical Trial; Genomics; Metabolism; Nutrition

Outcome Measures

Primary Outcomes (4)

• 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.

Secondary Outcomes (10)

• Postprandial triacylglycerol changes

  Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.

• 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 insulin 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.

Other Outcomes (8)

• Immune cell populations

  Baseline and 6 hours after consumption of the dietary lipid challenge.

• CRP

  Before the start of a study day.

• WHR

  Baseline

Study Arms (6)

V-A-C

EXPERIMENTAL

Order of administration: 1. 100% vegetable fat blend 2. 100% Anhydrous Milk Fat (AMF) 3. 100% Cream (AMF + milk fat globular membranes)

Other: 100% vegetable blend; Other: 100% AMF; Other: 100% cream

V-C-A

EXPERIMENTAL

Order of administration: 1. 100% vegetable fat blend 2. 100% Cream (AMF + milk fat globular membranes) 3. 100% Anhydrous Milk Fat (AMF)

Other: 100% vegetable blend; Other: 100% AMF; Other: 100% cream

A-V-C

EXPERIMENTAL

Order of administration: 1. 100% Anhydrous Milk Fat (AMF) 2. 100% vegetable fat blend 3. 100% Cream (AMF + milk fat globular membranes)

Other: 100% vegetable blend; Other: 100% AMF; Other: 100% cream

A-C-V

EXPERIMENTAL

Order of administration: 1. 100% Anhydrous Milk Fat (AMF) 2. 100% Cream (AMF + milk fat globular membranes) 3. 100% vegetable fat blend

Other: 100% vegetable blend; Other: 100% AMF; Other: 100% cream

C-A-V

EXPERIMENTAL

Order of administration: 1. 100% Cream (AMF + milk fat globular membranes) 2. 100% Anhydrous Milk Fat (AMF) 3. 100% vegetable fat blend

Other: 100% vegetable blend; Other: 100% AMF; Other: 100% cream

C-V-A

EXPERIMENTAL

Order of administration: 1. 100% Cream (AMF + milk fat globular membranes) 2. 100% vegetable fat blend 3. 100% Anhydrous Milk Fat (AMF)

Other: 100% vegetable blend; Other: 100% AMF; Other: 100% cream

Interventions

100% vegetable blend OTHER

Dietary lipid challenge test: 600 ml skimmed milk plus 95 gram of vegetable fat blend.

A-C-V; A-V-C; C-A-V; C-V-A; V-A-C; V-C-A

100% AMF OTHER

Dietary lipid challenge test: 600 ml skimmed milk plus 95 gram of anhydrous milk fat.

A-C-V; A-V-C; C-A-V; C-V-A; V-A-C; V-C-A

100% cream OTHER

Dietary lipid challenge test: 600 ml skimmed milk plus 95 gram of anhydrous milk fat plus milk fat globular membranes.

A-C-V; A-V-C; C-A-V; C-V-A; V-A-C; V-C-A

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead
• Friesland Campina: collaborator

Study Sites (1)

Wageningen University, Division of Human Nutrition

Wageningen, Gelderland, 6700 EV, Netherlands

RECRUITING

Study Officials

• Lydia Afman, PhD

  Wageningen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Michielsen, MSc

CONTACT

+31 317 484 864; charlotte.michielsen@wur.nl

Lydia Afman, PhD

CONTACT

+31 317 485 789; lydia.afman@wur.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: November 26, 2019
• Study Start: December 2, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: November 26, 2019

Record last verified: 2019-11

Locations

NL (1)