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LipaemiaDAIRYMATNCT03656367

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

A study testing Cheddar cheese, Blended and homogenized cheddar cheese and An analog milk in people with Lipaemia, run by Anne Birgitte Raben at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Lipaemia
What is being tested?
Cheddar cheese, Blended and homogenized cheddar cheese and An analog milk
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteDenmark
Study dates
10 Sep 2018to 21 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 16Show fewer
  • 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 locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Nutrition, Exercise and Sports

    Frederiksberg, 1958

Other trials in Denmark

About this study

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.

Read the 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.

Conditions
Lipaemia
Being tested
Cheddar cheese, Blended and homogenized cheddar cheese, An analog milk, An analog cheese
Keywords
glycaemia, insulinemia, lipaemia, appetite
Medical subject headings
Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cheddar cheeseDietary supplement

    The reference product is a commercial matured cheddar cheese

  • Blended and homogenized cheddar cheeseDietary 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 milkDietary 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 cheeseDietary 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

Study groups in NCT03656367
Study groupRoleWhat they receive
All subjectsExperimentalCross-over study (all subjects receive all interventions) * Cheddar cheese * Blended and homogenized cheddar cheese * An analog milk * An analog cheese
Receives: Dietary Supplement: Cheddar cheese; Dietary Supplement: Blended and homogenized cheddar cheese; Dietary Supplement: An analog milk; Dietary Supplement: An analog cheese
Healthy subjects only (subgroup)OtherIf 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
Receives: Dietary Supplement: Cheddar cheese; Dietary Supplement: Blended and homogenized cheddar cheese; Dietary Supplement: An analog milk; Dietary Supplement: An analog cheese

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 0-8 hour

  2. Apolipoprotein B48

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

    Measured: 0-8 hour

Secondary outcomes (5)

  1. Cholesterol (total, LDL and HDL cholesterol)

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

    Measured: 0-8 hour

  2. Free Fatty Acid (FFA)

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

    Measured: 0-8 hour

  3. Insulin

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

    Measured: 0-8 hour

  4. Glucose

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

    Measured: 0-8 hour

  5. Apolipoproteins

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

    Measured: 0-8 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2018
  2. Study start10 Sep 2018
  3. Primary completion21 Mar 2019
  4. Study completion21 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03656367
Sponsor's protocol ID
B346 (H-18024447)
Acronym
DAIRYMAT
Status last verified
Oct 2021
First submitted
30 Aug 2018
Last updated
1 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34477812

  • 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.

    PubMed 34357348

  • 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.

    PubMed 32500911

Questions about this trial

What is this clinical trial studying?

A study testing Cheddar cheese, Blended and homogenized cheddar cheese and An analog milk in people with Lipaemia, run by Anne Birgitte Raben at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Triglyceride (time frame: 0-8 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03656367, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.

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