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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03656367
Acronym
DAIRYMAT
Enrollment
25
Registered
2018-09-04
Start date
2018-09-10
Completion date
2019-03-21
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lipaemia

Keywords

glycaemia, insulinemia, lipaemia, appetite

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.

Interventions

DIETARY_SUPPLEMENTCheddar cheese

The reference product is a commercial matured cheddar cheese

DIETARY_SUPPLEMENTBlended and homogenized cheddar cheese

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

DIETARY_SUPPLEMENTAn analog milk

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

DIETARY_SUPPLEMENTAn analog cheese

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

Sponsors

University of Aarhus
CollaboratorOTHER
Arla Foods
CollaboratorINDUSTRY
Anne Birgitte Raben
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Due to the characteristics of the study design, blinding of project personnel and participants is not possible. However, statistical analyses of the results will be performed in a blinded fashion.

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Triglyceride0-8 hourThe sample size is calculated on this endpoint. Fasting and postprandial concentrations of triglycerides (mmol/L) are measured after intake of a test meal.
Apolipoprotein B480-8 hourCo-primary endpoint. Fasting and postprandial concentrations of apolipoprotein B48 are measured after intake of a test meal.

Secondary

MeasureTime frameDescription
Cholesterol (total, LDL and HDL cholesterol)0-8 hourFasting and postprandial concentrations of cholesterol (mmol/L) are measured after intake of a test meal.
Free Fatty Acid (FFA)0-8 hourFasting and postprandial concentrations of FFA (umol/L) are measured after intake of a test meal.
Insulin0-8 hourFasting and postprandial concentrations of insulin (pmol/L) are measured after intake of a test meal.
Glucose0-8 hourFasting and postprandial concentrations of glucose (mmol/L) are measured after intake of a test meal.
Apolipoproteins0-8 hourFasting and postprandial concentrations of apolipoproteins (e.g. B100) are measured after intake of a test meal.

Other

MeasureTime frameDescription
Subjective appetite sensation0-8 hourSubjective 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)
Metabolomics0-8 hourDetailed absorption kinetics will be evaluated by NMR-based metabolomics
Acute energy intake8 hours after test mealAcute energy intake is evaluated by energy intake of an ad libitum meal that is served after the 8-hour test meal period
Appetite hormones0-8 hourFasting and postprandial concentrations of appetite hormones (e.g. GLP-1) may be measured after intake of a test meal.
detailed metabolomics0-8 hourDetailed absorption kinetics will be evaluated by LCMS-based metabolomics
Paracetamol0-8 hourGastric emptying rate is evaluated by paracetamol (measured as fasting and postprandial concentrations after intake of a test meal).

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026