Effects of Plant Polar Lipids on Glucose Tolerance

Healthy Clinical Trial

Official title:

Effects of Oat and Oat Components on Cardiometabolic- and Cognitive Test Variables

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06148974
• Other study ID #: Prot.2018/8-23
• Status: Completed
• Phase: N/A
• Start date: December 6, 2023
• Est. completion date: January 25, 2024

Study information

• Verified date: January 2024
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 25, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Polar lipid 1
15g plant polar lipids from plant source 1. The lipid supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g).
• Polar lipid 2
15g plant polar lipids from plant source 2. The lipid supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g).
• Non-polar lipids
15g non-polar plant lipids from plant source 1. The lipids supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g).

Other:
• No lipids
A commercial white wheat flour bread as a source of available carbohydrates (50 g), without added lipids.

Locations

Country	Name	City	State
Sweden	Lund University, dep of Food Technology, Engineering, and Nutrition	Lund	Välj...

Sponsors (1)

Lead Sponsor	Collaborator
Anne Nilsson

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose concentration (glucose tolerance)	Test products will be consumed at breakfast. Blood glucose will be determined repeatedly after the breakfast and also following a standardised lunch. The primary outcome measures for glucose concentrations are incremental areas under the curve after the test breakfast and after the standardised lunch	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	Serum insulin concentrations	Test products will be consumed at breakfast. Insulin will be determined repeatedly after the breakfast and also following a standardised lunch. The primary outcome measures for insulin are incremental areas under the curve after the test breakfast and after the standardised lunch	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.
Secondary	Subjective hunger sensations	Test products will be consumed at breakfast. Subjective appetite variables will be determined repeatedly after the breakfast and also following a standardised lunch. The secondary outcome measures are areas under the curve after the test breakfast and after the standardised lunch. Subjective appetite variables will be determined using a 100 mm Visual Analogue Scale (VAS).	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	Subjective satiety sensations	Test products will be consumed at breakfast. Subjective appetite variables will be determined repeatedly after the breakfast and also following a standardised lunch. The secondary outcome measures are areas under the curve after the test breakfast and after the standardised lunch. Subjective appetite variables will be determined using a 100 mm Visual Analogue Scale (VAS).	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	Subjective sensations of desire to eat	Test products will be consumed at breakfast. Subjective appetite variables will be determined repeatedly after the breakfast and also following a standardised lunch. The secondary outcome measures are areas under the curve after the test breakfast and after the standardised lunch. Subjective appetite variables will be determined using a 100 mm Visual Analogue Scale (VAS).	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.