Postprandial Effects of High-fat Meals With Different Dairy Products on Lipid Metabolism and Inflammation
Primary Purpose
Healthy, Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Butter
Cheese
Whipped cream
Sour cream
Sponsored by

About this trial
This is an interventional prevention trial for Healthy focused on measuring Healthy Volunteers, Obese Volunteers
Eligibility 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
Sites / Locations
- University of Oslo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy
Obese
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changes in levels of circulating triglycerides
Secondary Outcome Measures
Changes in total cholesterol and lipoproteins
Changes in total cholesterol and lipoproteins, such as low-density lipoprotein and high-density lipoprotein
Changes in levels of apolipoproteins
Changes in levels of apolipoproteins, i.e. apo A1, apo B, apo B-48 and apo C-III
Changes in levels of free fatty acids
Changes in levels of circulating inflammatory markers
Changes in levels of inflammatory markers, such as cytokines, acute phase proteins and soluble adhesion molecules
Changes in levels of circulating endotoxins
Changes in gene expressions (mRNA and microRNA) of genes related to lipid metabolism and inflammation in Peripheral Blood Mononuclear Cells (PBMC)
Changes in whole genome transcriptomics in PBMC
Check DNA for Single Nucleotide Polymorphisms related to responses of a high-fat meal
Examine epigenetics through DNA methylation and histone modification
Changes of plasma and urine metabolomics
Changes in levels of metabolites, such as glucose and amino acids
Changes in levels of gut hormones
Changes in levels of gut hormones, such as peptide YY (PYY)
Changes in experiences of hunger and satiety by Visual Analogue Scales (VAS) questionnaire
Full Information
NCT ID
NCT02836106
First Posted
June 8, 2016
Last Updated
November 2, 2022
Sponsor
University of Oslo
Collaborators
Tine, The Research Council of Norway
1. Study Identification
Unique Protocol Identification Number
NCT02836106
Brief Title
Postprandial Effects of High-fat Meals With Different Dairy Products on Lipid Metabolism and Inflammation
Official Title
Postprandial Effects of High-fat Meals With Different Dairy Products on Lipid Metabolism and Inflammation in Healthy and Obese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
Tine, The Research Council of Norway
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Overweight, Obesity
Keywords
Healthy Volunteers, Obese Volunteers
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy
Arm Type
Experimental
Arm Description
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.
Arm Title
Obese
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Butter
Intervention Description
Butter with jam and three slices of bread
Intervention Type
Other
Intervention Name(s)
Cheese
Intervention Description
Cheese with jam and three slices of bread
Intervention Type
Other
Intervention Name(s)
Whipped cream
Intervention Description
Whipped cream with jam and three slices of bread
Intervention Type
Other
Intervention Name(s)
Sour cream
Intervention Description
Sour cream with jam and three slices of bread
Primary Outcome Measure Information:
Title
Changes in levels of circulating triglycerides
Time Frame
Measured at baseline and 2,4 and 6 hours after intake of test meal
Secondary Outcome Measure Information:
Title
Changes in total cholesterol and lipoproteins
Description
Changes in total cholesterol and lipoproteins, such as low-density lipoprotein and high-density lipoprotein
Time Frame
Measured at baseline and 2,4 and 6 hours after intake of test meal
Title
Changes in levels of apolipoproteins
Description
Changes in levels of apolipoproteins, i.e. apo A1, apo B, apo B-48 and apo C-III
Time Frame
Measured at baseline and 2,4 and 6 hours after intake of test meal
Title
Changes in levels of free fatty acids
Time Frame
Measured at baseline and 2,4 and 6 hours after intake of test meal
Title
Changes in levels of circulating inflammatory markers
Description
Changes in levels of inflammatory markers, such as cytokines, acute phase proteins and soluble adhesion molecules
Time Frame
Measured at baseline and 2,4 and 6 hours after intake of test meal
Title
Changes in levels of circulating endotoxins
Time Frame
Measured at baseline and 2,4 and 6 hours after intake of test meal
Title
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
Title
Changes in whole genome transcriptomics in PBMC
Time Frame
Measured at baseline and 2,4 and 6 hours after intake of test meal
Title
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
Title
Examine epigenetics through DNA methylation and histone modification
Time Frame
Measured at baseline and 6 hours after intake of test meal
Title
Changes of plasma and urine metabolomics
Description
Changes in levels of metabolites, such as glucose and amino acids
Time Frame
Measured at baseline and 2,4 and 6 hours after intake of test meal
Title
Changes in levels of gut hormones
Description
Changes in levels of gut hormones, such as peptide YY (PYY)
Time Frame
Measured at baseline and 2,4 and 6 hours after intake of test meal
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stine M Ulven, PhD
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oslo
City
Oslo
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
31208475
Citation
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.
Results Reference
derived
PubMed Identifier
30759235
Citation
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.
Results Reference
derived
Learn more about this trial
Postprandial Effects of High-fat Meals With Different Dairy Products on Lipid Metabolism and Inflammation
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