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

• Sponsor: Lund University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05844085
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 1
• Patients Per Site Per Month: 19.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects; Diet Intervention	Other: Non-polar lipids; Other: No lipids; Dietary Supplement: Polar lipids low; Dietary Supplement: Polar lipids high	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Randomized, controlled, crossover trialRandomized, controlled, crossover trial
• Masking: Single (Participant)
• Masking Description: the test meals have similar appearance
• Primary Purpose: Prevention
• Official Title: Effects of Oat and Oat Components on Cardiometabolic- and Cognitive Test Variables
• Actual Study Start Date: May 5, 2023
• Anticipated Primary Completion Date: Jun 5, 2023
• Anticipated Study Completion Date: Jun 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Non-polar lipids A food product containing 15 g plant-based non-polar lipids. The fat is consumed blended with a carbohydrate source containing 50 g available carbohydrates.	Other: Non-polar lipids; The shame comparator lipid intervention product contains no polar lipids. The lipids are mixed with a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. The total amounts of lipids are15g, and the total amounts of available carbohydrates are 50 g.
Placebo Comparator: No Lipids Reference product. A carbohydrate source containing 50 g available carbohydrates.	Other: No lipids; The placebo comparator contains no added lipids. The product contains a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. The total amounts of available carbohydrates are 50 g.
Experimental: Polar Lipids low A food product containing 15 g plant-based lipids, of which 50% is polar lipids and 50% is non-polar lipids.The fat is consumed blended with a carbohydrate source containing 50 g available carbohydrates.	Dietary Supplement: Polar lipids low; The experimental intervention product contains 7,5 g plant based lipids polar lipids and 7.5 g plant based lipids non polarlipids. The lipids are mixed with a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. TThe total amounts of available carbohydrates are 50 g.
Experimental: Polar Lipids high A food product containing 15 g plant-based lipids, of which 100 % is polar lipids. The fat is consumed blended with a carbohydrate source containing 50 g available carbohydrates.	Dietary Supplement: Polar lipids high; The experimental intervention product contains15 g plant based polar lipids. The lipids are mixed with a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. The total amounts of available carbohydrates are 50 g.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

2. 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).

3. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Human Trial Facility, Food Technology, Engineering and Nutrition, LTH, Lund University	Lund	Välj...	Sweden	22100

Sponsors and Collaborators

• Lund University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anne Nilsson, Associate professor, Lund University
• ClinicalTrials.gov Identifier: NCT05844085
• Other Study ID Numbers: Prot.2018/8-Dnr.2018/658
• First Posted: May 6, 2023
• Last Update Posted: May 6, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 6, 2023