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Completed

NCT Number: NCT02836106

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo

Oslo, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Butter

Other

Butter with jam and three slices of bread

Cheese

Other

Cheese with jam and three slices of bread

Whipped cream

Other

Whipped cream with jam and three slices of bread

Sour cream

Other

Sour cream with jam and three slices of bread

Primary outcomes

  1. Changes in levels of circulating triglycerides

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

Secondary outcomes

  1. Changes in total cholesterol and lipoproteins

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

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

  2. Changes in levels of apolipoproteins

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

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

  3. Changes in levels of free fatty acids

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

  4. Changes in levels of circulating inflammatory markers

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

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

  5. Changes in levels of circulating endotoxins

    Time frame: 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)

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

  7. Changes in whole genome transcriptomics in PBMC

    Time frame: 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

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

  9. Examine epigenetics through DNA methylation and histone modification

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

  10. Changes of plasma and urine metabolomics

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

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

  11. Changes in levels of gut hormones

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

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

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

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

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • The Research Council of Norway
  • Tine

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 18, 2016
Registry last updated
Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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