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

NCT ID: NCT05844085

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-05
• Study Completion Date: 2023-06-06

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.

Conditions

Healthy Subjects; Diet Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Non-polar lipids

Intervention Type: OTHER

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.

No Lipids

Reference product. A carbohydrate source containing 50 g available carbohydrates.

Group Type: PLACEBO_COMPARATOR

No lipids

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Polar lipids low

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: EXPERIMENTAL

Polar lipids high

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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
• CVD
• Metabolic diseases
• Inflammatory bowel diseases.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Anne Nilsson

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Human Trial Facility, Food Technology, Engineering and Nutrition, LTH, Lund University

Lund, Välj..., Sweden

Countries

Sweden

Other Identifiers

Prot.2018/8-Dnr.2018/658

Identifier Type: -

Identifier Source: org_study_id