Effects of Plant Polar Lipids on Glucose Tolerance

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Polar lipid 2; Dietary supplement: Non-polar lipids; Other: No lipids; Dietary supplement: Polar lipid 1

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Välj...
    • Lund, Välj..., Sweden, 22100
      • Lund University, dep of Food Technology, Engineering, and Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polar lipid 1; 15 g Plant polar lip 1 consumed with a white wheat bread including 50 g available carbohydrates	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).
Experimental: Polar lipid 2; 15 g Plant polar lipids 2 consumed with a white wheat bread including 50 g available carbohydrates	Dietary supplement: 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).
Active Comparator: non-polar lipids; 15 g commonly consumed non-polar lipids consumed with a white wheat bread including 50 g available carbohydrates	Dietary supplement: 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).
Placebo Comparator: no lipids; A white wheat bread including 50 g available carbohydrates	Other: No lipids; A commercial white wheat flour bread as a source of available carbohydrates (50 g), without added lipids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Anne Nilsson

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2023
• Primary Completion (Actual): January 25, 2024
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Prot.2018/8-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No