Effects of Plant Based Lipids on Glucose Regulation and Cognitive Variables

Obesity Clinical Trial

Official title:

Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic- and Cognitive Test Variables

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05276128
• Other study ID #: 2018/658
• Status: Completed
• Phase: N/A
• Start date: March 20, 2022
• Est. completion date: April 27, 2022

Study information

• Verified date: April 2022
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall goal is to increase the knowledge that 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 of this project is to evaluate effects in healthy humans on acute postprandial glucose regulation of plant based lipids. Due to the tight connection between cardiometabolic health and cognitive functions, a secondary issue is to investigate effects of test foods on cognitive test variables and mood parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 27, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Apparently healthy subjects

• Between 20 and 40 years old

• Body mass index between 19-28 kg / m2),

• Consuming a non-vegetarian diet generally in line with the Nordic nutrition recommendations.

Exclusion Criteria:

• Fasting blood glucose concentration >6.1 mmol/L

• Known metabolic or gastrointestinal disorder (eg diabetes, high cholesterol, high blood pressure, IBS), or other disease that may affect the study results.

• Regular medication, except for long-term and stable medication for the lack or reduced production of thyroid hormone (eg Levaxin).

• Antibiotics or probiotics for at least four weeks before the start of the study,

• The use of tobacco products

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Dietary Supplement:
• lipids
Investigations of dose-response effects of 3 different doses of an bioactive plant based lipid consumed at breakfast, after overnight fasting. Total amounts of lipids in each test portion are 15g, and the lower doses are supplemented with a control lipid to sum upp to 15 g total lipids. A control product with15g control lipids and without active lipids is also included. The lipids are supplemented to a white wheat bread, corresponding to 50 g available starch. A White wheat bread portion without lipid supplementation is included as a well studied reference product.

Locations

Country	Name	City	State
Sweden	Anne Nilsson	Lund	Välj...
Sweden	The Human Trial Facility, Food Technology engineering and Nutrition, 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
Other	Cognitive test variable	Pilot study. Computerised test measuring aspects of selective attention, working memory and psychomotor reaction time	60 minutes after start of breakfast, after 120 minutes, and after 180 minutes
Primary	glucose tolerance	Postprandial blood glucose responses	3 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Secondary	Insulin responses	Postprandial insulin responses	3 hours. Fasting (time =0 minutes), 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Secondary	Mood variables	Registration of subjective mood ratings (valence and activity) on 0-100 mm Visual Analogue Scales (VAS) at fasting and thereafter every hour until 180 min. Extremes of the sensations of the variables is at the two ends of the scales, i.e. 0 mm relates to the extrem of low senations sensations and 100 mm correspond to the highest sensation of the variables.	60 minutes after start of test product, after 120 minutes and after 180 minutes
Secondary	Appetite sensations	Subjective sensations of hunger, satiety, and desire to eat are registered on 0-100 mm VAS scales. Extremes of the sensations of the variables is at the two ends of the scales, i.e. 0 mm relates to the extrem of low senations sensations and 100 mm correspond to the highest sensation of the variables.	3 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes