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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03658681
Enrollment
20
Registered
2018-09-05
Start date
2018-03-13
Completion date
2019-12-31
Last updated
2020-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Microbiota, Postprandial Blood Glucose, Satiety

Keywords

Fat quality, Blood glucose, Gut microbiota, Satiety, Dietary intervention

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.

Interventions

OTHERSaturated fat 14.9 E%

Dietary cross-over study with saturated fat

OTHERPolyunsaturated fat 13.6 E%

Dietary cross-over study with polyunsaturated fat

Sponsors

Mills DA
CollaboratorINDUSTRY
Nofima
CollaboratorOTHER
University of Oslo
CollaboratorOTHER
Oslo Metropolitan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Intervention with cross-over design. Two test meals will be tested.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Blood glucose response measured in capillary bloodChange from baseline at day 4Blood glucose response after oral glucose tolerance test (OGTT) measured in Finger-prick capillary blood samples
Serum Insulin response measured in venous blood samplesChange from baseline at day 4Serum Insulin response after OGTT measured in venous blood samples

Secondary

MeasureTime frameDescription
Microbiota analyses in fecesChange from baseline at day 4Microbiota analyses in feces are measured before and after intake of test meals. Change in microbiota will be analysed
Serum triglyceride responseChange from baseline at day 4Triglyceride response are measured are measured after OGTT
Serum cholesterolChange from baseline at day 4Serum cholesterol are measured fasting after intake of test meals
Hunger and satiety hormones (e.g. GLP2, PYY)Change from baseline at day 4The response in hunger and satiety hormones after OGTT
Hydrogen breath response measured in expired airChange from baseline at day 4Hydrogen breath response after OGTT measured in expired air by Gastroanalyzer
mRNA analyses in PBMCChange from baseline at day 4PBMC are collected before and after OGTT. The change in mRNA level will be analyzed
Quantitative assessment of metabolites in urineChange from baseline at day 4Morning 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
Quantitative assessment of metabolites in plasmaChange from baseline at day 4Plasma for metabolome analyses are collected after intake of test meals. Metabolites in plasma will be quantified using UHPLC-qTOF-MS
Visual analogue scale (VAS)Change from baseline at day 4Subjective 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.
Inflammatory markers (e.g. CRP)Change from baseline at day 4Response in Inflammatory markers are measured after OGTT
Free fatty acidsChange from baseline at day 4Plasma free fatty acids are measured after intake of test meals

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026