Healthy, Overweight, Obesity
Conditions
Keywords
Healthy Volunteers, Obese Volunteers
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.
Interventions
Sponsors
Tine
The Research Council of Norway
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in levels of circulating triglycerides | Measured at baseline and 2,4 and 6 hours after intake of test meal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in levels of apolipoproteins | 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 | Measured at baseline and 2,4 and 6 hours after intake of test meal | — |
| Changes in levels of circulating inflammatory markers | 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 | 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 total cholesterol and lipoproteins | 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 |
| 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 | 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 | 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 | 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 | — |
Countries
Norway
Outcome results
None listed