Clinical Trials Directory

Trials / Completed

CompletedNCT03658681

Effect of Fat Quality on Glycemic Regulation and Gut Microbiota After a Short-time Intervention in Healthy Individuals

Fat Quality and Blood Glucose

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Oslo Metropolitan University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERSaturated fat 14.9 E%Dietary cross-over study with saturated fat
OTHERPolyunsaturated fat 13.6 E%Dietary cross-over study with polyunsaturated fat

Timeline

Start date
2018-03-13
Primary completion
2019-01-31
Completion
2019-12-31
First posted
2018-09-05
Last updated
2020-05-07

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT03658681. Inclusion in this directory is not an endorsement.