Skip to main content
OpenTrials
Completed

NCT Number: NCT03656367

Designing Biofunctional Dairy Foods: Matrix Structure of Dairy Products in Relation to Lipaemia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports

Frederiksberg, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cheddar cheese

Dietary Supplement

The reference product is a commercial matured cheddar cheese

Blended and homogenized cheddar cheese

Dietary Supplement

A blended and homogenized cheddar cheese (a spread) which, compared to the reference, has a minimal protein network and has smaller fat droplet

An analog milk

Dietary Supplement

An anolog milk (i.e. milk with a cheese-like nutritional composition) which, compared to the reference, does not contain a protein network

An analog cheese

Dietary Supplement

This analog cheese (a gel/yoghurt) is produced from the analog milk which, compared to the reference, has a protein network, however it is a network that differs from the reference

Primary outcomes

  1. Triglyceride

    Time frame: 0-8 hour

    The sample size is calculated on this endpoint. Fasting and postprandial concentrations of triglycerides (mmol/L) are measured after intake of a test meal.

  2. Apolipoprotein B48

    Time frame: 0-8 hour

    Co-primary endpoint. Fasting and postprandial concentrations of apolipoprotein B48 are measured after intake of a test meal.

Secondary outcomes

  1. Cholesterol (total, LDL and HDL cholesterol)

    Time frame: 0-8 hour

    Fasting and postprandial concentrations of cholesterol (mmol/L) are measured after intake of a test meal.

  2. Free Fatty Acid (FFA)

    Time frame: 0-8 hour

    Fasting and postprandial concentrations of FFA (umol/L) are measured after intake of a test meal.

  3. Insulin

    Time frame: 0-8 hour

    Fasting and postprandial concentrations of insulin (pmol/L) are measured after intake of a test meal.

  4. Glucose

    Time frame: 0-8 hour

    Fasting and postprandial concentrations of glucose (mmol/L) are measured after intake of a test meal.

  5. Apolipoproteins

    Time frame: 0-8 hour

    Fasting and postprandial concentrations of apolipoproteins (e.g. B100) are measured after intake of a test meal.

Other outcomes

  1. Paracetamol

    Time frame: 0-8 hour

    Gastric emptying rate is evaluated by paracetamol (measured as fasting and postprandial concentrations after intake of a test meal).

  2. Metabolomics

    Time frame: 0-8 hour

    Detailed absorption kinetics will be evaluated by NMR-based metabolomics

  3. Subjective appetite sensation

    Time frame: 0-8 hour

    Subjective appetite sensation (e.g. hunger, satiety, thirst) will be evaluated by visual analogue scales (VAS). The VAS is a line (100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating of the subject's sensations. For example, Q: "How hungry do you feel now?", rating: "not at all" (=0 mm) and "extremely" (=100 mm)

  4. Acute energy intake

    Time frame: 8 hours after test meal

    Acute energy intake is evaluated by energy intake of an ad libitum meal that is served after the 8-hour test meal period

  5. Appetite hormones

    Time frame: 0-8 hour

    Fasting and postprandial concentrations of appetite hormones (e.g. GLP-1) may be measured after intake of a test meal.

  6. detailed metabolomics

    Time frame: 0-8 hour

    Detailed absorption kinetics will be evaluated by LCMS-based metabolomics

Sponsors and collaborators

Lead sponsor

Anne Birgitte Raben

Other

Collaborators

  • Arla Foods
  • University of Aarhus

Registry information

Acronym: DAIRYMAT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 4, 2018
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.