Clinical trial NCT03656367: Designing Biofunctional Dairy Foods: Matrix Structure of Dairy Products in Relation to Lipaemia
Official title: Designing Biofunctional Dairy Foods: Matrix Structure of Dairy Products in Relation to Lipaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipaemia
Keywords: glycaemia
insulinemia
lipaemia
appetite
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: Arla Foods
First posted: 2018-09-04
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The overall aim of this study is to investigate how dairy products with different structures and textures affect lipid absorption kinetics in the acute postprandial period via blood lipid biochemistry.

The study will be conducted as a randomized acute cross-over meal study. Apparently healthy men will be recruited in the study. They will on 4 test days consume the 4 dairy products and blood will be drawn the following 8 hours.

Detailed description: The overall aim of this study is to investigate how dairy products with similar nutrient content but different structures and textures affect lipid absorption kinetics in the acute postprandial period via blood lipid biochemistry, as well as nuclear magnetic resonance (NMR) and liquid chromatography mass spectrometry (LCMS)-based metabolomics.

The study will be conducted as a randomized acute cross-over meal study. On four different test days (with a minimum of 2 weeks washout period) four dairy products with similar nutrient composition but different structures or textures will be tested. During each meal test a single dairy product (+ bread and water) is served and postprandial blood samples are collected the following 8 hours. Subjective appetite measurements (VAS) are filled in during the 8-hour period and an ad libitum meal is served in the end of the day.

25 apparently healthy men (weight stable, 18-40 years, 18.5-24.9 kg/m2) will be recruited.

Eligibility criteria: Inclusion Criteria:

* Apparently healthy men
* 18-40 years of age
* Body mass index (BMI): 18.5-24.9 kg/m\^2
* Non-smoker
* Haemoglobin concentration ≥8.4 mmol/L

Exclusion Criteria:

* Dislike for dairy products such as milk, cheese and yoghurt
* Weight change \>3 kg 2 months prior to study
* Any other blood donation \< 3 month prior to study and during study, than the blood donation that is included in this study
* Intensive physical training (\>10 hours of per week)
* Self-reported eating disorders or irregular eating schedules (e.g. skipping breakfast) and uncommon diets (vegetarians, vegans etc.)
* Alcohol intake above the recommendation from the Danish Health and Medicines Authority (\>21 units of alcohol per week)
* Night- or shift work
* Food intolerance and allergies related to test products e.g. lactose and gluten
* Dietary supplements, if not taken on a regular basis
* Currently use, or use within previously 3 months of prescription medication, except non-prescription primary analgetica (NSAID and paracetamol) to relieve e.g. head ache and stomach pain, and glucocorticoider for topical use e.g. in ointment and creams.
* Chronic diseases e.g. cancer within the past 5 years (except adequately-treated localized basal cell skin cancer), asthma, back pain, thyroid disease, heart disease, diabetes, inflammation
* Disorders: neurological, sleep, diagnosed psychiatric disorder, and gastro intestinal and liver disorders.
* Surgical treatment of obesity and abdominal surgery
* Inability, physically or mental, to comply with the procedures required by the study protocol as evaluated by the daily study manager, principal investigator or clinical responsible
* Subject's general condition contraindicates continuing the study as evaluated by the daily study manager, principal investigator or clinical responsible
* Simultaneous participation in other clinical intervention studies

Primary outcomes:
measure: Triglyceride
timeFrame: 0-8 hour
measure: Apolipoprotein B48
timeFrame: 0-8 hour
Secondary outcomes:
measure: Cholesterol (total, LDL and HDL cholesterol)
timeFrame: 0-8 hour
measure: Free Fatty Acid (FFA)
timeFrame: 0-8 hour
measure: Insulin
timeFrame: 0-8 hour
measure: Glucose
timeFrame: 0-8 hour
measure: Apolipoproteins
timeFrame: 0-8 hour
Other outcomes:
measure: Paracetamol
timeFrame: 0-8 hour
measure: Metabolomics
timeFrame: 0-8 hour
measure: Subjective appetite sensation
timeFrame: 0-8 hour
measure: Acute energy intake
timeFrame: 8 hours after test meal
measure: Appetite hormones
timeFrame: 0-8 hour
measure: detailed metabolomics
timeFrame: 0-8 hour
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Nutrition, Exercise and Sports
Study officials:
affiliation: University of Copenhagen
name: Anne B Raben, prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kjolbaek L, Schmidt JM, Rouy E, Jensen KJ, Astrup A, Bertram HC, Hammershoj M, Raben A. Matrix structure of dairy products results in different postprandial lipid responses: a randomized crossover trial. Am J Clin Nutr. 2021 Nov 8;114(5):1729-1742. doi: 10.1093/ajcn/nqab220.
citation: Thogersen R, Lindahl IEI, Khakimov B, Kjolbaek L, Juhl Jensen K, Astrup A, Hammershoj M, Raben A, Bertram HC. Progression of Postprandial Blood Plasma Phospholipids Following Acute Intake of Different Dairy Matrices: A Randomized Crossover Trial. Metabolites. 2021 Jul 14;11(7):454. doi: 10.3390/metabo11070454.
citation: Schmidt JM, Kjolbaek L, Jensen KJ, Rouy E, Bertram HC, Larsen T, Raben A, Astrup A, Hammershoj M. Influence of type of dairy matrix micro- and macrostructure on in vitro lipid digestion. Food Funct. 2020 Jun 24;11(6):4960-4972. doi: 10.1039/d0fo00785d.