Effects of Plant-based Polar Lipids on Acute and Second Meal Glucose Tolerance and Appetite Sensations

Not Applicable

Completed

• Conditions: Healthy Subjects; Diet Intervention

• Registration Number: NCT05844085
• Lead Sponsor: Lund University

Brief Summary

The overall goal of the project is to increase knowledge which can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the primary purpose is to evaluate effects on cardiometabolic test markers of bioactive compounds in healthy humans. Previously the investigators reported beneficial effects of oat polar lipids on cardiometabolic risk markers. In this study the effects previously observed will be compared with cardiometabolic effects of another plant based lipid.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-05-02
• Study Start: 2023-05-05
• Study First Posted: 2023-05-06
• Status Verified: 2023-06
• Primary Completion: 2023-06-06
• Study Completion: 2023-06-06
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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
• CVD
• Metabolic diseases
• Inflammatory bowel diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Blood glucose concentration (glucose tolerance)	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.	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 are incremental areas under the curve after the test breakfast and after the standardised lunch

Secondary Outcome Measures

Name	Time	Method
Subjective hunger sensations	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.	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).
Subjective sensations of desire to eat	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.	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).
Subjective satiety sensations	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.	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).

Trial Locations

Locations (1)

The Human Trial Facility, Food Technology, Engineering and Nutrition, LTH, Lund University; 🇸🇪 Lund, Välj..., Sweden