Effects of Plant Based Lipids on Glucose Regulation and Cognitive Variables

Sponsor
Lund University (Other)
Overall Status
Completed
CT.gov ID
NCT05276128
Collaborator
(none)
17
2
5
1.2
8.5
6.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: lipids
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic- and Cognitive Test Variables
Actual Study Start Date :
Mar 20, 2022
Actual Primary Completion Date :
Apr 27, 2022
Actual Study Completion Date :
Apr 27, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. glucose tolerance [3 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes]

    Postprandial blood glucose responses

Secondary Outcome Measures

  1. Insulin responses [3 hours. Fasting (time =0 minutes), 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes]

    Postprandial insulin responses

  2. Mood variables [60 minutes after start of test product, after 120 minutes and after 180 minutes]

    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.

  3. Appetite sensations [3 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes]

    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.

Other Outcome Measures

  1. Cognitive test variable [60 minutes after start of breakfast, after 120 minutes, and after 180 minutes]

    Pilot study. Computerised test measuring aspects of selective attention, working memory and psychomotor reaction time

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anne Nilsson Lund Välj... Sweden 22100
2 The Human Trial Facility, Food Technology engineering and Nutrition, Lund University Lund Välj... Sweden 22100

Sponsors and Collaborators

  • Lund University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anne Nilsson, Associate professor, Lund University
ClinicalTrials.gov Identifier:
NCT05276128
Other Study ID Numbers:
  • 2018/658
First Posted:
Mar 11, 2022
Last Update Posted:
Apr 28, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2022