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

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ClinicalTrials.gov Identifier: NCT02836106
Recruitment Status : Completed
First Posted : July 18, 2016
Last Update Posted : May 10, 2017
Sponsor:
Collaborators:
Tine
The Research Council of Norway
Information provided by (Responsible Party):
Stine Marie Ulven, University of Oslo

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Overweight Obesity Other: Butter Other: Cheese Other: Whipped cream Other: Sour cream Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Postprandial Effects of High-fat Meals With Different Dairy Products on Lipid Metabolism and Inflammation in Healthy and Obese Subjects
Study Start Date : June 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Healthy
Lean 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.
 Other: Butter
Butter with jam and three slices of bread

Other: Cheese
Cheese with jam and three slices of bread

Other: Whipped cream
Whipped cream with jam and three slices of bread

Other: Sour cream
Sour cream with jam and three slices of bread
Experimental: Obese
Overweight 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.
 Other: Butter
Butter with jam and three slices of bread

Other: Cheese
Cheese with jam and three slices of bread

Other: Whipped cream
Whipped cream with jam and three slices of bread

Other: Sour cream
Sour cream with jam and three slices of bread


Outcome Measures
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Primary Outcome Measures :
  1. Changes in levels of circulating triglycerides [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836106


Locations
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Norway
University of Oslo
Oslo, Norway
Sponsors and Collaborators
University of Oslo
Tine
The Research Council of Norway
Investigators
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Principal Investigator: Stine M Ulven, PhD University of Oslo
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stine Marie Ulven, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT02836106    
Other Study ID Numbers: 2016/418/REK sør-øst B
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Keywords provided by Stine Marie Ulven, University of Oslo:
Healthy Volunteers
Obese Volunteers
Additional relevant MeSH terms:
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Inflammation
Overweight
Pathologic Processes
Body Weight