Oslo Metropolitan University
Oslo, 0130, Norway
NCT Number: NCT03658681
The overall aim is to investigate effects of saturated versus polyunsaturated fat on glycemic regulation and satiety in a postprandial study with healthy individuals. The potential effects will be related to changes in gut microbiota, the circulating levels of short chain fatty acids, inflammation and gene expression in peripheral mononuclear blood cells.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Oslo, 0130, Norway
The intervention study will have a randomized, double blinded, cross-over design with different test meals consisting of saturated or polyunsaturated fat. The amount of fat will be identical in the test meals, but the fat quality will vary. The test meals are in the form of muffin and spread.
All participants will consume two muffins and minimum 20 g of spread a day for three consecutive days, consisting of either a high proportion of saturated fat or a high proportion of polyunsaturated fat. At day one (visit 1 and 3) and day four (visit 2 and 4) of the intervention week, the participants will perform a postprandial glucose test (OGTT, 75 g glucose in 100 ml water) at Oslo Metropolitan University. Blood samples will be taken before and at different time points after the glucose test. One week prior to the intervention week and during "wash-out" (11 days), the participants will consume the control products which are high in saturated fat.
At the screening visit (visit 0) the participants will be asked to limit the intake of dietary fat and fiber from oat and barley one week prior to visit 1 and during the study. Otherwise, participants will be asked not to change their diet and exercise habits during the study period. Individuals fulfilling the inclusion criteria will also be invited to participate in a cross-sectional study for investigating the gut microbiota in a healthy population.
An OGTT will be performed at visit 1, 2, 3 and 4.
The participants will receive test meals after screening and before visit 1, 2, and 3.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dietary cross-over study with saturated fat
Dietary cross-over study with polyunsaturated fat
Time frame: Change from baseline at day 4
Blood glucose response after oral glucose tolerance test (OGTT) measured in Finger-prick capillary blood samples
Time frame: Change from baseline at day 4
Serum Insulin response after OGTT measured in venous blood samples
Time frame: Change from baseline at day 4
Hydrogen breath response after OGTT measured in expired air by Gastroanalyzer
Time frame: Change from baseline at day 4
Plasma free fatty acids are measured after intake of test meals
Time frame: Change from baseline at day 4
Microbiota analyses in feces are measured before and after intake of test meals. Change in microbiota will be analysed
Time frame: Change from baseline at day 4
Triglyceride response are measured are measured after OGTT
Time frame: Change from baseline at day 4
Serum cholesterol are measured fasting after intake of test meals
Time frame: Change from baseline at day 4
The response in hunger and satiety hormones after OGTT
Time frame: Change from baseline at day 4
Response in Inflammatory markers are measured after OGTT
Time frame: Change from baseline at day 4
PBMC are collected before and after OGTT. The change in mRNA level will be analyzed
Time frame: Change from baseline at day 4
Morning urine are collected before and after intake of test meals. Metabolites in urine will be quantified using UHPLC-qTOF-MS. Change in metabolites before and after test meals will be analyzed
Time frame: Change from baseline at day 4
Plasma for metabolome analyses are collected after intake of test meals. Metabolites in plasma will be quantified using UHPLC-qTOF-MS
Time frame: Change from baseline at day 4
Subjective hunger and satiety after OGTT and will be measured on a 100 mm horizontal line. Marks towards right end on line indicates strong sensation for hunger and satiety, whereas marks towards left end indicates opposite sensation. The distance from left border of line to the mark indicates subjective sensation.
Oslo Metropolitan University
Other
Fat Quality and Blood Glucose
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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