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

Gut Microbiota Clinical Trial

Official title:

Fat Quality and Blood Glucose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03658681
• Other study ID #: 200642
• Status: Completed
• Phase: N/A
• Start date: March 13, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2019
• Source: Oslo Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gut Microbiota
• Postprandial Blood Glucose
• Satiety

Intervention

Other:
• Saturated fat 14.9 E%
Dietary cross-over study with saturated fat
• Polyunsaturated fat 13.6 E%
Dietary cross-over study with polyunsaturated fat

Locations

Country	Name	City	State
Norway	Oslo Metropolitan University	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Oslo Metropolitan University	Mills DA, Nofima, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose response measured in capillary blood	Blood glucose response after oral glucose tolerance test (OGTT) measured in Finger-prick capillary blood samples	Change from baseline at day 4
Primary	Serum Insulin response measured in venous blood samples	Serum Insulin response after OGTT measured in venous blood samples	Change from baseline at day 4
Secondary	Hydrogen breath response measured in expired air	Hydrogen breath response after OGTT measured in expired air by Gastroanalyzer	Change from baseline at day 4
Secondary	Free fatty acids	Plasma free fatty acids are measured after intake of test meals	Change from baseline at day 4
Secondary	Microbiota analyses in feces	Microbiota analyses in feces are measured before and after intake of test meals. Change in microbiota will be analysed	Change from baseline at day 4
Secondary	Serum triglyceride response	Triglyceride response are measured are measured after OGTT	Change from baseline at day 4
Secondary	Serum cholesterol	Serum cholesterol are measured fasting after intake of test meals	Change from baseline at day 4
Secondary	Hunger and satiety hormones (e.g. GLP2, PYY)	The response in hunger and satiety hormones after OGTT	Change from baseline at day 4
Secondary	Inflammatory markers (e.g. CRP)	Response in Inflammatory markers are measured after OGTT	Change from baseline at day 4
Secondary	mRNA analyses in PBMC	PBMC are collected before and after OGTT. The change in mRNA level will be analyzed	Change from baseline at day 4
Secondary	Quantitative assessment of metabolites in urine	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	Change from baseline at day 4
Secondary	Quantitative assessment of metabolites in plasma	Plasma for metabolome analyses are collected after intake of test meals. Metabolites in plasma will be quantified using UHPLC-qTOF-MS	Change from baseline at day 4
Secondary	Visual analogue scale (VAS)	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.	Change from baseline at day 4