Skip to content

Effects of Plant Based Lipids on Glucose Regulation and Cognitive Variables

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05276128
Enrollment
17
Registered
2022-03-11
Start date
2022-03-20
Completion date
2022-04-27
Last updated
2022-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabete Type 2, Obesity

Brief 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.

Interventions

DIETARY_SUPPLEMENTlipids

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.

Sponsors

Lund University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
glucose tolerance3 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutesPostprandial blood glucose responses

Secondary

MeasureTime frameDescription
Insulin responses3 hours. Fasting (time =0 minutes), 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutesPostprandial insulin responses
Mood variables60 minutes after start of test product, after 120 minutes and after 180 minutesRegistration 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.
Appetite sensations3 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutesSubjective 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.

Other

MeasureTime frameDescription
Cognitive test variable60 minutes after start of breakfast, after 120 minutes, and after 180 minutesPilot study. Computerised test measuring aspects of selective attention, working memory and psychomotor reaction time

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026