Effects of Plant Based Lipids on Glucose Regulation and Cognitive Variables
Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic- and Cognitive Test Variables
1 other identifier
interventional
17
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2022
CompletedFirst Posted
Study publicly available on registry
March 11, 2022
CompletedStudy Start
First participant enrolled
March 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2022
CompletedApril 28, 2022
April 1, 2022
1 month
March 2, 2022
April 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Insulin responses
3 hours. Fasting (time =0 minutes), 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Mood variables
60 minutes after start of test product, after 120 minutes and after 180 minutes
Appetite sensations
3 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Other Outcomes (1)
Cognitive test variable
60 minutes after start of breakfast, after 120 minutes, and after 180 minutes
Study Arms (5)
WWB Reference
OTHERWhite wheat bread (WWB) without lipid supplements. The effects of this high glycaemic product on postprandial glucose and insulin responses are well studied.
WWB 5g active lipids
EXPERIMENTALWWB supplemented with 5 g active lipids, and 10 g control lipids
WWB 10g active lipids
EXPERIMENTALWWB supplemented with 10g active lipids, and 5 g control lipids
WWB 15g active lipids
EXPERIMENTALWWB supplemented with 15g active lipids, and 0 g control lipids
WWB 15 g control lipids
ACTIVE COMPARATORWWB supplemented with 15g control lipids
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
Study Sites (2)
Anne Nilsson
Lund, Välj..., 22100, Sweden
The Human Trial Facility, Food Technology engineering and Nutrition, Lund University
Lund, Välj..., 22100, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
March 2, 2022
First Posted
March 11, 2022
Study Start
March 20, 2022
Primary Completion
April 27, 2022
Study Completion
April 27, 2022
Last Updated
April 28, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
There is a plan to make Individual Participant Data (IPD) and related data dictionaries available. The data will be published in a scientific journal as supplementary material simultaneously as the study results. The test persons names are coded and no individual participant can be identified.