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Clinical Trials/NCT05276128
NCT05276128
Completed
Not Applicable

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

Lund University2 sites in 1 country17 target enrollmentMarch 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabete Type 2
Sponsor
Lund University
Enrollment
17
Locations
2
Primary Endpoint
glucose tolerance
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 20, 2022
End Date
April 27, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anne Nilsson

Associate professor

Lund University

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

Outcomes

Primary Outcomes

glucose tolerance

Time Frame: 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 Outcomes

  • 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)

Study Sites (2)

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