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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836106
• Other study ID #: 2016/418/REK sør-øst B
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: April 2017

Study information

• Verified date: November 2022
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Inflammation
• Obesity
• Overweight

Intervention

Other:
• Butter
Butter with jam and three slices of bread
• Cheese
Cheese with jam and three slices of bread
• Whipped cream
Whipped cream with jam and three slices of bread
• Sour cream
Sour cream with jam and three slices of bread

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
University of Oslo	The Research Council of Norway, Tine

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in levels of circulating triglycerides		Measured at baseline and 2,4 and 6 hours after intake of test meal
Secondary	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
Secondary	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
Secondary	Changes in levels of free fatty acids		Measured at baseline and 2,4 and 6 hours after intake of test meal
Secondary	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
Secondary	Changes in levels of circulating endotoxins		Measured at baseline and 2,4 and 6 hours after intake of test meal
Secondary	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
Secondary	Changes in whole genome transcriptomics in PBMC		Measured at baseline and 2,4 and 6 hours after intake of test meal
Secondary	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
Secondary	Examine epigenetics through DNA methylation and histone modification		Measured at baseline and 6 hours after intake of test meal
Secondary	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
Secondary	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
Secondary	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