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Completed

NCT Number: NCT06148974

Effects of Plant Polar Lipids on Glucose Tolerance

In this randomized controlled trial, two different plant polar lipids are investigated with respect to their potential to affect acute and second meal glucose tolerance and appetite sensations. The effects are compared with a common non-polar commercial oil. The lipids are consumed spread on a white wheat bread. A white wheat bread without added lipids is included as a control product. The test products are consumed at breakfast, and test variables are investigated in the postprandial period after the test breakfast and also after a second meal standard lunch.

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lund University, dep of Food Technology, Engineering, and Nutrition

Lund, Välj..., 22100, Sweden

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Apparently healthy men and women
  • non-smokers
  • between 20-40 years of age
  • BMI between 18,5-30 kg/m2
  • No known metabolic disorders or food allergies.
  • The test subjects should follow a normal diet in accordance with the Nordic Nutrition Recommendations.

Exclusion criteria

  • Fasting blood glucose ≥6.1 mmol/L
  • Use of antibiotics or probiotics in the last three months or during the study period.
  • Smoking
  • Blood donation during the last two months and during the study.
  • Food allergies or food intolerances
  • Cardiovascular diseases
  • Metabolic diseases
  • Inflammatory bowel diseases.

Treatment and study plan

Polar lipid 1

Dietary Supplement

15g plant polar lipids from plant source 1. The lipid supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g).

Polar lipid 2

Dietary Supplement

15g plant polar lipids from plant source 2. The lipid supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g).

Non-polar lipids

Dietary Supplement

15g non-polar plant lipids from plant source 1. The lipids supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g).

No lipids

Other

A commercial white wheat flour bread as a source of available carbohydrates (50 g), without added lipids.

Primary outcomes

  1. Blood glucose concentration (glucose tolerance)

    Time frame: 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.

    Test products will be consumed at breakfast. Blood glucose will be determined repeatedly after the breakfast and also following a standardised lunch. The primary outcome measures for glucose concentrations are incremental areas under the curve after the test breakfast and after the standardised lunch

Secondary outcomes

  1. Serum insulin concentrations

    Time frame: 5.5 hours. Fasting (time =0), 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.

    Test products will be consumed at breakfast. Insulin will be determined repeatedly after the breakfast and also following a standardised lunch. The primary outcome measures for insulin are incremental areas under the curve after the test breakfast and after the standardised lunch

  2. Subjective hunger sensations

    Time frame: 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.

    Test products will be consumed at breakfast. Subjective appetite variables will be determined repeatedly after the breakfast and also following a standardised lunch. The secondary outcome measures are areas under the curve after the test breakfast and after the standardised lunch. Subjective appetite variables will be determined using a 100 mm Visual Analogue Scale (VAS).

  3. Subjective satiety sensations

    Time frame: 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.

    Test products will be consumed at breakfast. Subjective appetite variables will be determined repeatedly after the breakfast and also following a standardised lunch. The secondary outcome measures are areas under the curve after the test breakfast and after the standardised lunch. Subjective appetite variables will be determined using a 100 mm Visual Analogue Scale (VAS).

  4. Subjective sensations of desire to eat

    Time frame: 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.

    Test products will be consumed at breakfast. Subjective appetite variables will be determined repeatedly after the breakfast and also following a standardised lunch. The secondary outcome measures are areas under the curve after the test breakfast and after the standardised lunch. Subjective appetite variables will be determined using a 100 mm Visual Analogue Scale (VAS).

Sponsors and collaborators

Lead sponsor

Anne Nilsson

Other

Registry information

Official study title

Effects of Oat and Oat Components on Cardiometabolic- and Cognitive Test Variables

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 28, 2023
Registry last updated
Jan 26, 2024

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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