Effects of Plant Based Lipids on Glucose Regulation and Cognitive Variables

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabete Type 2
• Intervention / Treatment: Dietary supplement: lipids

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Välj...
    • Lund, Välj..., Sweden, 22100
      • Anne Nilsson
    • Lund, Välj..., Sweden, 22100
      • The Human Trial Facility, Food Technology engineering and Nutrition, Lund University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: WWB Reference; White wheat bread (WWB) without lipid supplements. The effects of this high glycaemic product on postprandial glucose and insulin responses are well studied.	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.
Experimental: WWB 5g active lipids; WWB supplemented with 5 g active lipids, and 10 g control lipids	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.
Experimental: WWB 10g active lipids; WWB supplemented with 10g active lipids, and 5 g control lipids	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.
Experimental: WWB 15g active lipids; WWB supplemented with 15g active lipids, and 0 g control lipids	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.
Active Comparator: WWB 15 g control lipids; WWB supplemented with 15g control lipids	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Lund University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2022
• Primary Completion (Actual): April 27, 2022
• Study Completion (Actual): April 27, 2022

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2018/658

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No