Clinical trial NCT03658681: Effect of Fat Quality on Glycemic Regulation and Gut Microbiota After a Short-time Intervention in Healthy Individuals
Official title: Fat Quality and Blood Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Blood Glucose
Gut Microbiota
Satiety
Keywords: Fat quality
Blood glucose
Gut microbiota
Satiety
Dietary intervention
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: Mills DA
name: Nofima
name: University of Oslo
First posted: 2018-09-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Intervention with cross-over design. Two test meals will be tested.
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* BMI between 18,5 and 27 kg/m2
* Fasting plasma glucose ≤ 6.1 mmol/l

Exclusion Criteria:

* Chronic metabolic diseases such as diabetes type 1 and 2, coronary heart disease and cancer the last 6 months.
* Intestinal diseases such as chron's disease, ulcerative colitis and irritable bowel syndrome.
* Food allergy and intolerances towards grain and dairy products.
* Pregnant and lactating
* Smokers
* Fasting blood glucose ≥ 6.1 mmol/L
* BMI \<18,5 and \>27 kg/m2
* Planned weight reduction and or ± 5% weight change over the past three months.
* Use of antibiotics last 3 months before study entry and during the study period
* Use of probiotics the last month before study entry and during the study period
* Blood donor last 2 months before study entry and or during the study period
* Not willing to end the use of dietary supplements, including probiotic products, fish oil etc. four weeks prior to study entry and throughout the study period
* Alcohol consumption \> 40g / day
* Hormone treatments (except contraceptives)

Primary outcomes:
measure: Blood glucose response measured in capillary blood
timeFrame: Change from baseline at day 4
measure: Serum Insulin response measured in venous blood samples
timeFrame: Change from baseline at day 4
Secondary outcomes:
measure: Hydrogen breath response measured in expired air
timeFrame: Change from baseline at day 4
measure: Free fatty acids
timeFrame: Change from baseline at day 4
measure: Microbiota analyses in feces
timeFrame: Change from baseline at day 4
measure: Serum triglyceride response
timeFrame: Change from baseline at day 4
measure: Serum cholesterol
timeFrame: Change from baseline at day 4
measure: Hunger and satiety hormones (e.g. GLP2, PYY)
timeFrame: Change from baseline at day 4
measure: Inflammatory markers (e.g. CRP)
timeFrame: Change from baseline at day 4
measure: mRNA analyses in PBMC
timeFrame: Change from baseline at day 4
measure: Quantitative assessment of metabolites in urine
timeFrame: Change from baseline at day 4
measure: Quantitative assessment of metabolites in plasma
timeFrame: Change from baseline at day 4
measure: Visual analogue scale (VAS)
timeFrame: Change from baseline at day 4
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Metropolitan University
Study officials:
affiliation: Oslo Metropolitan University
name: Vibeke Telle-Hansen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Telle-Hansen VH, Gaundal L, Bastani N, Rud I, Byfuglien MG, Gjovaag T, Retterstol K, Holven KB, Ulven SM, Myhrstad MCW. Replacing saturated fatty acids with polyunsaturated fatty acids increases the abundance of Lachnospiraceae and is associated with reduced total cholesterol levels-a randomized controlled trial in healthy individuals. Lipids Health Dis. 2022 Sep 26;21(1):92. doi: 10.1186/s12944-022-01702-1.