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

Lipaemia Clinical Trial

— DAIRYMAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03656367
• Other study ID #: B346 (H-18024447)
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: March 21, 2019

Study information

• Verified date: October 2021
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 21, 2019
• Est. primary completion date: March 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemias
• Lipaemia

Intervention

Dietary Supplement:
• Cheddar cheese
The reference product is a commercial matured cheddar cheese
• Blended 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
• An 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
• An 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

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports	Frederiksberg

Sponsors (3)

Lead Sponsor	Collaborator
Anne Birgitte Raben	Arla Foods, University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Kjølbæk L, Schmidt JM, Rouy E, Jensen KJ, Astrup A, Bertram HC, Hammershøj M, Raben A. Matrix structure of dairy products results in different postprandial lipid responses: a randomized crossover trial. Am J Clin Nutr. 2021 Sep 3. pii: nqab220. doi: 10.10 — View Citation

Schmidt JM, Kjølbæk L, Jensen KJ, Rouy E, Bertram HC, Larsen T, Raben A, Astrup A, Hammershøj 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. — View Citation

Thøgersen R, Lindahl IEI, Khakimov B, Kjølbæk L, Juhl Jensen K, Astrup A, Hammershøj M, Raben A, Bertram HC. Progression of Postprandial Blood Plasma Phospholipids Following Acute Intake of Different Dairy Matrices: A Randomized Crossover Trial. Metabolit — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Paracetamol	Gastric emptying rate is evaluated by paracetamol (measured as fasting and postprandial concentrations after intake of a test meal).	0-8 hour
Other	Metabolomics	Detailed absorption kinetics will be evaluated by NMR-based metabolomics	0-8 hour
Other	Subjective appetite sensation	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)	0-8 hour
Other	Acute energy intake	Acute energy intake is evaluated by energy intake of an ad libitum meal that is served after the 8-hour test meal period	8 hours after test meal
Other	Appetite hormones	Fasting and postprandial concentrations of appetite hormones (e.g. GLP-1) may be measured after intake of a test meal.	0-8 hour
Other	detailed metabolomics	Detailed absorption kinetics will be evaluated by LCMS-based metabolomics	0-8 hour
Primary	Triglyceride	The sample size is calculated on this endpoint. Fasting and postprandial concentrations of triglycerides (mmol/L) are measured after intake of a test meal.	0-8 hour
Primary	Apolipoprotein B48	Co-primary endpoint. Fasting and postprandial concentrations of apolipoprotein B48 are measured after intake of a test meal.	0-8 hour
Secondary	Cholesterol (total, LDL and HDL cholesterol)	Fasting and postprandial concentrations of cholesterol (mmol/L) are measured after intake of a test meal.	0-8 hour
Secondary	Free Fatty Acid (FFA)	Fasting and postprandial concentrations of FFA (umol/L) are measured after intake of a test meal.	0-8 hour
Secondary	Insulin	Fasting and postprandial concentrations of insulin (pmol/L) are measured after intake of a test meal.	0-8 hour
Secondary	Glucose	Fasting and postprandial concentrations of glucose (mmol/L) are measured after intake of a test meal.	0-8 hour
Secondary	Apolipoproteins	Fasting and postprandial concentrations of apolipoproteins (e.g. B100) are measured after intake of a test meal.	0-8 hour