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
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Condition or disease | Intervention/treatment | Phase |
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Healthy Overweight Obesity | Other: Butter Other: Cheese Other: Whipped cream Other: Sour cream | Not Applicable |
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 |
Arm | Intervention/treatment |
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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.
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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.
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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 |
- Changes in levels of circulating triglycerides [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]
- 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
- 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
- Changes in levels of free fatty acids [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]
- 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
- Changes in levels of circulating endotoxins [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]
- 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 ]
- Changes in whole genome transcriptomics in PBMC [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]
- 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 ]
- Examine epigenetics through DNA methylation and histone modification [ Time Frame: Measured at baseline and 6 hours after intake of test meal ]
- 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
- 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)
- 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 ]

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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 |
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

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
Norway | |
University of Oslo | |
Oslo, Norway |
Principal Investigator: | Stine M Ulven, PhD | University of Oslo |
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 |
Healthy Volunteers Obese Volunteers |
Inflammation Overweight Pathologic Processes Body Weight |