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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05844085
Other study ID # Prot.2018/8-Dnr.2018/658
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 5, 2023
Est. completion date June 6, 2023

Study information

Verified date June 2023
Source Lund University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 6, 2023
Est. primary completion date June 6, 2023
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 - CVD - Metabolic diseases - Inflammatory bowel diseases.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.
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.

Locations

Country Name City State
Sweden The Human Trial Facility, Food Technology, Engineering and Nutrition, LTH, Lund University Lund Välj...

Sponsors (1)

Lead Sponsor Collaborator
Lund University

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 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 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.
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