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

Anne Birgitte Raben

Status: Completed

Conditions: Lipaemia

Treatments: Dietary Supplement: Blended and homogenized cheddar cheese; Dietary Supplement: Cheddar cheese; Dietary Supplement: An analog milk; Dietary Supplement: An analog cheese

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03656367

B346 (H-18024447)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 2 patient groups

All subjects

Experimental group

Description:

Cross-over study (all subjects receive all interventions) * Cheddar cheese * Blended and homogenized cheddar cheese * An analog milk * An analog cheese

Treatment:

Dietary Supplement: Blended and homogenized cheddar cheese

Dietary Supplement: An analog milk

Dietary Supplement: An analog cheese

Dietary Supplement: Cheddar cheese

Healthy subjects only (subgroup)

Other group

Description:

If any subjects (against our hypothesis) have indices of metabolic syndrome i.e. raised fasting glucose or TG concentration, secondary analyses will be conducted to assess results without these subjects. All subjects receive all interventions) * Cheddar cheese * Blended and homogenized cheddar cheese * An analog milk * An analog cheese

Treatment:

Dietary Supplement: Blended and homogenized cheddar cheese

Dietary Supplement: An analog milk

Dietary Supplement: An analog cheese

Dietary Supplement: Cheddar cheese