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Effects of Plant Based Lipids on Glucose Regulation and Cognitive Variables

Primary Purpose

Diabete Type 2, Obesity

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
lipids
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabete Type 2

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Anne Nilsson
  • The Human Trial Facility, Food Technology engineering and Nutrition, Lund University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Experimental

Experimental

Experimental

Active Comparator

Arm Label

WWB Reference

WWB 5g active lipids

WWB 10g active lipids

WWB 15g active lipids

WWB 15 g control lipids

Arm Description

White wheat bread (WWB) without lipid supplements. The effects of this high glycaemic product on postprandial glucose and insulin responses are well studied.

WWB supplemented with 5 g active lipids, and 10 g control lipids

WWB supplemented with 10g active lipids, and 5 g control lipids

WWB supplemented with 15g active lipids, and 0 g control lipids

WWB supplemented with 15g control lipids

Outcomes

Primary Outcome Measures

glucose tolerance
Postprandial blood glucose responses

Secondary Outcome Measures

Insulin responses
Postprandial insulin responses
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.
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.

Full Information

First Posted
March 2, 2022
Last Updated
April 27, 2022
Sponsor
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT05276128
Brief Title
Effects of Plant Based Lipids on Glucose Regulation and Cognitive Variables
Official Title
Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic- and Cognitive Test Variables
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 20, 2022 (Actual)
Primary Completion Date
April 27, 2022 (Actual)
Study Completion Date
April 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabete Type 2, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WWB Reference
Arm Type
Other
Arm Description
White wheat bread (WWB) without lipid supplements. The effects of this high glycaemic product on postprandial glucose and insulin responses are well studied.
Arm Title
WWB 5g active lipids
Arm Type
Experimental
Arm Description
WWB supplemented with 5 g active lipids, and 10 g control lipids
Arm Title
WWB 10g active lipids
Arm Type
Experimental
Arm Description
WWB supplemented with 10g active lipids, and 5 g control lipids
Arm Title
WWB 15g active lipids
Arm Type
Experimental
Arm Description
WWB supplemented with 15g active lipids, and 0 g control lipids
Arm Title
WWB 15 g control lipids
Arm Type
Active Comparator
Arm Description
WWB supplemented with 15g control lipids
Intervention Type
Dietary Supplement
Intervention Name(s)
lipids
Intervention Description
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.
Primary Outcome Measure Information:
Title
glucose tolerance
Description
Postprandial blood glucose responses
Time Frame
3 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Secondary Outcome Measure Information:
Title
Insulin responses
Description
Postprandial insulin responses
Time Frame
3 hours. Fasting (time =0 minutes), 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Title
Mood variables
Description
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.
Time Frame
60 minutes after start of test product, after 120 minutes and after 180 minutes
Title
Appetite sensations
Description
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.
Time Frame
3 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Other Pre-specified Outcome Measures:
Title
Cognitive test variable
Description
Pilot study. Computerised test measuring aspects of selective attention, working memory and psychomotor reaction time
Time Frame
60 minutes after start of breakfast, after 120 minutes, and after 180 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Anne Nilsson
City
Lund
State/Province
Välj...
ZIP/Postal Code
22100
Country
Sweden
Facility Name
The Human Trial Facility, Food Technology engineering and Nutrition, Lund University
City
Lund
State/Province
Välj...
ZIP/Postal Code
22100
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.

Learn more about this trial

Effects of Plant Based Lipids on Glucose Regulation and Cognitive Variables

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