Clinical trial NCT02836106: 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
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Overweight
Obesity
Keywords: Healthy Volunteers
Obese Volunteers
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Tine
name: The Research Council of Norway
First posted: 2016-07-18
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Changes in levels of circulating triglycerides
timeFrame: Measured at baseline and 2,4 and 6 hours after intake of test meal
Secondary outcomes:
measure: Changes in total cholesterol and lipoproteins
timeFrame: Measured at baseline and 2,4 and 6 hours after intake of test meal
measure: Changes in levels of apolipoproteins
timeFrame: Measured at baseline and 2,4 and 6 hours after intake of test meal
measure: Changes in levels of free fatty acids
timeFrame: Measured at baseline and 2,4 and 6 hours after intake of test meal
measure: Changes in levels of circulating inflammatory markers
timeFrame: Measured at baseline and 2,4 and 6 hours after intake of test meal
measure: Changes in levels of circulating endotoxins
timeFrame: Measured at baseline and 2,4 and 6 hours after intake of test meal
measure: Changes in gene expressions (mRNA and microRNA) of genes related to lipid metabolism and inflammation in Peripheral Blood Mononuclear Cells (PBMC)
timeFrame: Measured at baseline and 2,4 and 6 hours after intake of test meal
measure: Changes in whole genome transcriptomics in PBMC
timeFrame: Measured at baseline and 2,4 and 6 hours after intake of test meal
measure: Check DNA for Single Nucleotide Polymorphisms related to responses of a high-fat meal
timeFrame: Measured at baseline and 2,4 and 6 hours after intake of test meal
measure: Examine epigenetics through DNA methylation and histone modification
timeFrame: Measured at baseline and 6 hours after intake of test meal
measure: Changes of plasma and urine metabolomics
timeFrame: Measured at baseline and 2,4 and 6 hours after intake of test meal
measure: Changes in levels of gut hormones
timeFrame: Measured at baseline and 2,4 and 6 hours after intake of test meal
measure: Changes in experiences of hunger and satiety by Visual Analogue Scales (VAS) questionnaire
timeFrame: Measured at baseline and 2,4 and 6 hours after intake of test meal
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: University of Oslo
name: Stine M Ulven, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.