Clinical trial NCT06148974: Effects of Plant Polar Lipids on Glucose Tolerance
Official title: Effects of Oat and Oat Components on Cardiometabolic- and Cognitive Test Variables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: In this randomized controlled trial, two different plant polar lipids are investigated with respect to their potential to affect acute and second meal glucose tolerance and appetite sensations. The effects are compared with a common non-polar commercial oil. The lipids are consumed spread on a white wheat bread. A white wheat bread without added lipids is included as a control product. The test products are consumed at breakfast, and test variables are investigated in the postprandial period after the test breakfast and also after a second meal standard lunch.


Eligibility criteria: Inclusion Criteria:

* Apparently healthy men and women
* non-smokers
* between 20-40 years of age
* BMI between 18,5-30 kg/m2
* No known metabolic disorders or food allergies.
* The test subjects should follow a normal diet in accordance with the Nordic Nutrition Recommendations.

Exclusion Criteria:

* Fasting blood glucose ≥6.1 mmol/L
* Use of antibiotics or probiotics in the last three months or during the study period.
* Smoking
* Blood donation during the last two months and during the study.
* Food allergies or food intolerances
* Cardiovascular diseases
* Metabolic diseases
* Inflammatory bowel diseases.

Primary outcomes:
measure: Blood glucose concentration (glucose tolerance)
timeFrame: 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.
Secondary outcomes:
measure: Serum insulin concentrations
timeFrame: 5.5 hours. Fasting (time =0), 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.
measure: Subjective hunger sensations
timeFrame: 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.
measure: Subjective satiety sensations
timeFrame: 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.
measure: Subjective sensations of desire to eat
timeFrame: 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University, dep of Food Technology, Engineering, and Nutrition
state: Välj...
Study officials:
References: