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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Obesity; Overweight
• Intervention / Treatment: Other: Butter; Other: Cheese; Other: Whipped cream; Other: Sour cream

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: The Research Council of Norway; Tine
• Investigators: Principal Investigator: Stine M Ulven, PhD, University of Oslo

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: June 8, 2016
• First Submitted That Met QC Criteria: July 13, 2016
• First Posted (Estimate): July 18, 2016

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Obese Volunteers
• Additional Relevant MeSH Terms: Pathologic Processes; Body Weight; Inflammation; Overweight
• Other Study ID Numbers: 2016/418/REK sør-øst B