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Completed

NCT Number: NCT05276128

Effects of Plant Based Lipids on Glucose Regulation and Cognitive 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.

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Key information

Conditions

Diabete Type 2 Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anne Nilsson, Lund, Välj..., Sweden

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lipids

Dietary Supplement

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 outcomes

  1. 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

  1. Insulin responses

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Cognitive test variable

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 11, 2022
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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