NCT03656367

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

September 10, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2019

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

August 30, 2018

Last Update Submit

October 25, 2021

Conditions

Lipaemia

Keywords

glycaemiainsulinemialipaemiaappetite

Outcome Measures

Primary Outcomes (2)

  • 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

  • Apolipoprotein B48

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

    0-8 hour

Secondary Outcomes (5)

  • Cholesterol (total, LDL and HDL cholesterol)

    0-8 hour

  • Free Fatty Acid (FFA)

    0-8 hour

  • Insulin

    0-8 hour

  • Glucose

    0-8 hour

  • Apolipoproteins

    0-8 hour

Other Outcomes (6)

  • Paracetamol

    0-8 hour

  • Metabolomics

    0-8 hour

  • Subjective appetite sensation

    0-8 hour

  • +3 more other outcomes

Study Arms (2)

All subjects

EXPERIMENTAL

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

Dietary Supplement: Cheddar cheeseDietary Supplement: Blended and homogenized cheddar cheeseDietary Supplement: An analog milkDietary Supplement: An analog cheese

Healthy subjects only (subgroup)

OTHER

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

Dietary Supplement: Cheddar cheeseDietary Supplement: Blended and homogenized cheddar cheeseDietary Supplement: An analog milkDietary Supplement: An analog cheese

Interventions

Cheddar cheeseDIETARY_SUPPLEMENT

The reference product is a commercial matured cheddar cheese

All subjectsHealthy subjects only (subgroup)
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

All subjectsHealthy subjects only (subgroup)
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

All subjectsHealthy subjects only (subgroup)
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

All subjectsHealthy subjects only (subgroup)

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Apparently healthy men
  • years of age
  • Body mass index (BMI): 18.5-24.9 kg/m\^2
  • Non-smoker
  • Haemoglobin concentration ≥8.4 mmol/L

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition, Exercise and Sports

Frederiksberg, 1958, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 34477812RESULT

  • 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.

    PMID: 34357348RESULT

  • 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.

    PMID: 32500911RESULT

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Anne B Raben, prof

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 4, 2018

Study Start

September 10, 2018

Primary Completion

March 21, 2019

Study Completion

March 21, 2019

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

DK(1)