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HealthyNCT02836106

Postprandial Effects of High-fat Meals With Different Dairy Products on Lipid Metabolism and Inflammation

A study testing Butter, Cheese and Whipped cream in people with Healthy and Overweight, run by University of Oslo at 1 site in Norway.

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 aim of this project is to elucidate how high-fat meals with different kinds of dairy products affect postprandial responses of lipid metabolism and inflammatory markers in healthy and obese subjects. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Overweight, Obesity
What is being tested?
Butter, Cheese and Whipped cream
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteNorway
Study dates
Jun 2016to Apr 2017
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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The study will include both men and women aged 18-70 years with the aim of an even age and gender balance.
  • Participants in the healthy group will need to have a body mass index (BMI) between 18.5 - 24.9 kg/m2 and a waist circumference (WC) of <94 cm for men and<80 cm for women.
  • Participants in the obese group will need to have a BMI of ≥25 kg/m2 and a waist circumference of ≥94 cm for men and ≥80 cm for women.
  • All subjects must be willing to eat three slices of bread with a dairy product and jam as breakfast.

Who cannot join

  • BMI <18.5 kg/m2 or >25 kg/m2 in the healthy group and <25 kg/m2 in the obese group
  • WC ≥94 for men and ≥80 cm for women in the healthy group, <94/80 cm for men/women in the obese group
  • Weight change of ± 5 % of body weight in the last three months
  • TG ≥1.3 mmol/L in the healthy group
  • CRP >10 mg/L
  • Total cholesterol >6.1 mmol/L for subjects 18-29 years, >6.9 mmol/L for subjects 30-49 years and >7.8 mmol/L for subjects ≥50 years old
Show all 16Show fewer
  • Blood pressure >160/100 mm Hg
  • Comorbidities including diabetes type I and II (blood glucose ≥7 mmol/L fasting), coronary heart disease, haemophilia, anaemia (hemoglobin <120 gram/L), gastro intestinal disease and hyperthyroidism (TSH >4 mU/L)
  • Pregnant or lactating
  • Allergic or intolerant to gluten, milk protein and/or lactose
  • Use of medications affecting lipid metabolism or inflammation
  • Unwilling to seponate omega-3 rich supplements four weeks prior to screening and during the study period
  • Hormone treatment (stabile dose of contraception or thyroxin for the last three months excepted)
  • Blood donation two months prior to test day 1 or during the study period
  • Tobacco smoking
  • Excessive regular alcohol consumption (>40 grams per day) or prior to the test day

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • University of Oslo

    Oslo

Other trials in Norway

About this study

Official title: Postprandial Effects of High-fat Meals With Different Dairy Products on Lipid Metabolism and Inflammation in Healthy and Obese Subjects

The aim of this project is to elucidate how high-fat meals with different kinds of dairy products affect postprandial responses of lipid metabolism and inflammatory markers in healthy and obese subjects.

Being tested
Butter, Cheese, Whipped cream, Sour cream
Keywords
Healthy Volunteers, Obese Volunteers
Medical subject headings
Overweight, Obesity

What participants receive

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

  • ButterOther

    Butter with jam and three slices of bread

  • CheeseOther

    Cheese with jam and three slices of bread

  • Whipped creamOther

    Whipped cream with jam and three slices of bread

  • Sour creamOther

    Sour cream with jam and three slices of bread

Study groups in NCT02836106
Study groupRoleWhat they receive
HealthyExperimentalLean subjects (BMI<25) with a waist circumference of <94 cm for men and<80 cm for women. Subjects will be randomly assigned to eat butter, cheese, whipped cream and sour cream in a cross-over design.
Receives: Other: Butter; Other: Cheese; Other: Whipped cream; Other: Sour cream
ObeseExperimentalOverweight and obese subjects (BMI≥25) with a waist circumference of ≥94 cm for men and ≥80 cm for women. Subjects will be randomly assigned to eat butter, cheese, whipped cream and sour cream in a cross-over design.
Receives: Other: Butter; Other: Cheese; Other: Whipped cream; Other: Sour cream

What is being measured

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

  1. Changes in levels of circulating triglycerides

    Measured: Measured at baseline and 2,4 and 6 hours after intake of test meal

Secondary outcomes (12)

  1. Changes in total cholesterol and lipoproteins

    Changes in total cholesterol and lipoproteins, such as low-density lipoprotein and high-density lipoprotein

    Measured: Measured at baseline and 2,4 and 6 hours after intake of test meal

  2. Changes in levels of apolipoproteins

    Changes in levels of apolipoproteins, i.e. apo A1, apo B, apo B-48 and apo C-III

    Measured: Measured at baseline and 2,4 and 6 hours after intake of test meal

  3. Changes in levels of free fatty acids

    Measured: Measured at baseline and 2,4 and 6 hours after intake of test meal

  4. Changes in levels of circulating inflammatory markers

    Changes in levels of inflammatory markers, such as cytokines, acute phase proteins and soluble adhesion molecules

    Measured: Measured at baseline and 2,4 and 6 hours after intake of test meal

  5. Changes in levels of circulating endotoxins

    Measured: Measured at baseline and 2,4 and 6 hours after intake of test meal

  6. Changes in gene expressions (mRNA and microRNA) of genes related to lipid metabolism and inflammation in Peripheral Blood Mononuclear Cells (PBMC)

    Measured: Measured at baseline and 2,4 and 6 hours after intake of test meal

  7. Changes in whole genome transcriptomics in PBMC

    Measured: Measured at baseline and 2,4 and 6 hours after intake of test meal

  8. Check DNA for Single Nucleotide Polymorphisms related to responses of a high-fat meal

    Measured: Measured at baseline and 2,4 and 6 hours after intake of test meal

  9. Examine epigenetics through DNA methylation and histone modification

    Measured: Measured at baseline and 6 hours after intake of test meal

  10. Changes of plasma and urine metabolomics

    Changes in levels of metabolites, such as glucose and amino acids

    Measured: Measured at baseline and 2,4 and 6 hours after intake of test meal

  11. Changes in levels of gut hormones

    Changes in levels of gut hormones, such as peptide YY (PYY)

    Measured: Measured at baseline and 2,4 and 6 hours after intake of test meal

  12. Changes in experiences of hunger and satiety by Visual Analogue Scales (VAS) questionnaire

    Measured: Measured at baseline and 2,4 and 6 hours after intake of test meal

Timeline

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

  1. First posted18 Jul 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionApr 2017
  4. Study completionApr 2017

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
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02836106
Sponsor's protocol ID
2016/418/REK sør-øst B
Status last verified
Nov 2022
First submitted
8 Jun 2016
Last updated
7 Nov 2022
Results posted
No

Publications

  • Hu J, D'Alessandro M, Hansson P, Holven KB, Thoresen M, Ulven SM. Use of Metabotyping to Identify Individuals With Different Triglyceride Response Curves After Intake of High-Fat Meals. Mol Nutr Food Res. 2026 May;70(9):e70482. doi: 10.1002/mnfr.70482.

    PubMed 42059346

  • Hansson P, Holven KB, Oyri LKL, Brekke HK, Gjevestad GO, Thoresen M, Ulven SM. Sex differences in postprandial responses to different dairy products on lipoprotein subclasses: a randomised controlled cross-over trial. Br J Nutr. 2019 Oct 14;122(7):780-789. doi: 10.1017/S0007114519001429.

    PubMed 31208475

  • Hansson P, Holven KB, Oyri LKL, Brekke HK, Biong AS, Gjevestad GO, Raza GS, Herzig KH, Thoresen M, Ulven SM. Meals with Similar Fat Content from Different Dairy Products Induce Different Postprandial Triglyceride Responses in Healthy Adults: A Randomized Controlled Cross-Over Trial. J Nutr. 2019 Mar 1;149(3):422-431. doi: 10.1093/jn/nxy291.

    PubMed 30759235

Questions about this trial

What is this clinical trial studying?

A study testing Butter, Cheese and Whipped cream in people with Healthy and Overweight, run by University of Oslo at 1 site in Norway.

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 4 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 7 Nov 2022. 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 Norway. 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?

Changes in levels of circulating triglycerides (time frame: Measured at baseline and 2,4 and 6 hours after intake of test meal). 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 NCT02836106, 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 7 Nov 2022.

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