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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy, Overweight, Obesity

Intervention / Treatment
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* Other: Butter
* Other: Cheese
* Other: Whipped cream
* Other: Sour cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy<br>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<br>* Butter with jam and three slices of bread<br>Other: Cheese<br>* Cheese with jam and three slices of bread<br>Other: Whipped cream<br>* Whipped cream with jam and three slices of bread<br>Other: Sour cream<br>* Sour cream with jam and three slices of bread<br>|
| Experimental: Obese<br>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<br>* Butter with jam and three slices of bread<br>Other: Cheese<br>* Cheese with jam and three slices of bread<br>Other: Whipped cream<br>* Whipped cream with jam and three slices of bread<br>Other: Sour cream<br>* Sour cream with jam and three slices of bread<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in levels of circulating triglycerides |  | Measured at baseline and 2,4 and 6 hours after intake of test meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in total cholesterol and lipoproteins | Changes in total cholesterol and lipoproteins, such as low-density lipoprotein and high-density lipoprotein | Measured at baseline and 2,4 and 6 hours after intake of test meal | 
| Changes in levels of apolipoproteins | Changes in levels of apolipoproteins, i.e. apo A1, apo B, apo B-48 and apo C-III | Measured at baseline and 2,4 and 6 hours after intake of test meal | 
| Changes in levels of free fatty acids |  | Measured at baseline and 2,4 and 6 hours after intake of test meal | 
| Changes in levels of circulating inflammatory markers | Changes in levels of inflammatory markers, such as cytokines, acute phase proteins and soluble adhesion molecules | Measured at baseline and 2,4 and 6 hours after intake of test meal | 
| Changes in levels of circulating endotoxins |  | 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) |  | Measured at baseline and 2,4 and 6 hours after intake of test meal | 
| Changes in whole genome transcriptomics in PBMC |  | 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 |  | Measured at baseline and 2,4 and 6 hours after intake of test meal | 
| Examine epigenetics through DNA methylation and histone modification |  | Measured at baseline and 6 hours after intake of test meal | 
| Changes of plasma and urine metabolomics | Changes in levels of metabolites, such as glucose and amino acids | Measured at baseline and 2,4 and 6 hours after intake of test meal | 
| Changes in levels of gut hormones | Changes in levels of gut hormones, such as peptide YY (PYY) | Measured at baseline and 2,4 and 6 hours after intake of test meal | 
| Changes in experiences of hunger and satiety by Visual Analogue Scales (VAS) questionnaire |  | Measured at baseline and 2,4 and 6 hours after intake of test meal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers, Obese Volunteers