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

Primary Purpose

Lipaemia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cheddar cheese
Blended and homogenized cheddar cheese
An analog milk
An analog cheese
Sponsored by
Anne Birgitte Raben
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lipaemia focused on measuring glycaemia, insulinemia, lipaemia, appetite

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts 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

Sites / Locations

  • Department of Nutrition, Exercise and Sports

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

All subjects

Healthy subjects only (subgroup)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cholesterol (total, LDL and HDL cholesterol)
Fasting and postprandial concentrations of cholesterol (mmol/L) are measured after intake of a test meal.
Free Fatty Acid (FFA)
Fasting and postprandial concentrations of FFA (umol/L) are measured after intake of a test meal.
Insulin
Fasting and postprandial concentrations of insulin (pmol/L) are measured after intake of a test meal.
Glucose
Fasting and postprandial concentrations of glucose (mmol/L) are measured after intake of a test meal.
Apolipoproteins
Fasting and postprandial concentrations of apolipoproteins (e.g. B100) are measured after intake of a test meal.

Full Information

First Posted
August 30, 2018
Last Updated
October 25, 2021
Sponsor
Anne Birgitte Raben
Collaborators
University of Aarhus, Arla Foods
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1. Study Identification

Unique Protocol Identification Number
NCT03656367
Brief Title
Designing Biofunctional Dairy Foods: Matrix Structure of Dairy Products in Relation to Lipaemia
Acronym
DAIRYMAT
Official Title
Designing Biofunctional Dairy Foods: Matrix Structure of Dairy Products in Relation to Lipaemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
March 21, 2019 (Actual)
Study Completion Date
March 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anne Birgitte Raben
Collaborators
University of Aarhus, Arla Foods

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipaemia
Keywords
glycaemia, insulinemia, lipaemia, appetite

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
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.
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All subjects
Arm Type
Experimental
Arm Description
Cross-over study (all subjects receive all interventions) Cheddar cheese Blended and homogenized cheddar cheese An analog milk An analog cheese
Arm Title
Healthy subjects only (subgroup)
Arm Type
Other
Arm 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
Intervention Type
Dietary Supplement
Intervention Name(s)
Cheddar cheese
Intervention Description
The reference product is a commercial matured cheddar cheese
Intervention Type
Dietary Supplement
Intervention Name(s)
Blended and homogenized cheddar cheese
Intervention Description
A blended and homogenized cheddar cheese (a spread) which, compared to the reference, has a minimal protein network and has smaller fat droplet
Intervention Type
Dietary Supplement
Intervention Name(s)
An analog milk
Intervention Description
An anolog milk (i.e. milk with a cheese-like nutritional composition) which, compared to the reference, does not contain a protein network
Intervention Type
Dietary Supplement
Intervention Name(s)
An analog cheese
Intervention Description
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 Outcome Measure Information:
Title
Triglyceride
Description
The sample size is calculated on this endpoint. Fasting and postprandial concentrations of triglycerides (mmol/L) are measured after intake of a test meal.
Time Frame
0-8 hour
Title
Apolipoprotein B48
Description
Co-primary endpoint. Fasting and postprandial concentrations of apolipoprotein B48 are measured after intake of a test meal.
Time Frame
0-8 hour
Secondary Outcome Measure Information:
Title
Cholesterol (total, LDL and HDL cholesterol)
Description
Fasting and postprandial concentrations of cholesterol (mmol/L) are measured after intake of a test meal.
Time Frame
0-8 hour
Title
Free Fatty Acid (FFA)
Description
Fasting and postprandial concentrations of FFA (umol/L) are measured after intake of a test meal.
Time Frame
0-8 hour
Title
Insulin
Description
Fasting and postprandial concentrations of insulin (pmol/L) are measured after intake of a test meal.
Time Frame
0-8 hour
Title
Glucose
Description
Fasting and postprandial concentrations of glucose (mmol/L) are measured after intake of a test meal.
Time Frame
0-8 hour
Title
Apolipoproteins
Description
Fasting and postprandial concentrations of apolipoproteins (e.g. B100) are measured after intake of a test meal.
Time Frame
0-8 hour
Other Pre-specified Outcome Measures:
Title
Paracetamol
Description
Gastric emptying rate is evaluated by paracetamol (measured as fasting and postprandial concentrations after intake of a test meal).
Time Frame
0-8 hour
Title
Metabolomics
Description
Detailed absorption kinetics will be evaluated by NMR-based metabolomics
Time Frame
0-8 hour
Title
Subjective appetite sensation
Description
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)
Time Frame
0-8 hour
Title
Acute energy intake
Description
Acute energy intake is evaluated by energy intake of an ad libitum meal that is served after the 8-hour test meal period
Time Frame
8 hours after test meal
Title
Appetite hormones
Description
Fasting and postprandial concentrations of appetite hormones (e.g. GLP-1) may be measured after intake of a test meal.
Time Frame
0-8 hour
Title
detailed metabolomics
Description
Detailed absorption kinetics will be evaluated by LCMS-based metabolomics
Time Frame
0-8 hour

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne B Raben, prof
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition, Exercise and Sports
City
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
34477812
Citation
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.
Results Reference
result
PubMed Identifier
34357348
Citation
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.
Results Reference
result
PubMed Identifier
32500911
Citation
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.
Results Reference
result

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

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