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Completed

NCT Number: NCT06340412

Effects of Intact and Disrupted Milk Fat Globule Membrane on Postprandial Metabolic Response to High-fat Dairy in Healthy Individuals

The aim of the study is to investigate the effects of milk fat globule membrane (MFGM) content and intactness on postprandial metabolic response to a high-fat meal in humans.

The investigators hypothesize that MFGM content and intactness alters the postprandial lipid profile and substrate metabolism in healthy individuals after consumption of a high-fat meal.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Aarhus, Aarhus University Hospital

Aarhus, 8200, Denmark

About this study

The subjects will be invited for four visits in total: one screening visit and three test days separated by a one-week washout period. At the test days, subjects will consume two high-fat meals composed of milk fat with intact MFGM, destroyed MFGM, and without MFGM, respectively. The first meal will be consumed as breakfast and the second meal will be consumed as lunch. Test meals will be isocaloric and with similar macronutrient composition. The meal will consist of a sandwich with a butter-like dairy product.

The three trial days will be completely alike, besides the interventions.

Subjects will arrive at the research lab the night before test day and stay inside a metabolic chamber to acclimatize.

The participants will have one intravenous (iv.) access placed in the elbow on the three trial days where blood samples will be collected at 15, 30, 60, 90, 120, 150 and 180 min after each test meal (breakfast and lunch).

Immediately after consuming each of the two test meals, the subjects will take 1,500mg paracetamol to determine ventricular emptying rate using the acetaminophen test. After this, the subjects can lay in the bed and watch TV, iPad, or work on their laptop.

Before and every hour after consumption of the test meals, the subjects will be asked to fill out an appetite questionnaire (visual analogue scale). At the end of the day the participants will be offered an "ad libitum meal" to measure if MFGM content and intactness influences ad libitum intake of calories at the next meal.

An one-way mixed model of linear regression will be used to compare postprandial area under the curve, ventricular emptying, and ad libitum food intake between the three test days. Secondary outcomes will be analyzed using a two-way mixed model of linear regression with repeated measurements.

Based on the results from a previous study that investigated the effects of the fat and protein structure in dairy products on postprandial triglycerides (20), the investigators will need 11 subjects to detect a 15% decrease in postprandial triglyceride AUC (α=0.05, β=0.80). To account for potential missing values, 12 subjects will be included in total.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18-40 years
  • Written and informed consent
  • HbA1c < 48 mmol/l

Exclusion criteria

  • Medicine with an impact on blood glucose, lipid profile, or blood pressure and birth control pills
  • BMI > 30kg/m2
  • Affected screening blood sample as evaluated by the clinical responsible investigator
  • Severe claustrophobia
  • Lactose intolerance
  • Doesn't speak and understand Danish
  • Commitment to special diets

Treatment and study plan

Sandwich with butter-like dairy product (40g milk fat) with intact MFGM. One sandwich for breakfast and one sandwich for lunch.

Dietary Supplement
  • Sandwich with butter-like dairy product (40g milk fat) with intact MFGM.

Sandwich with butter-like dairy product (40g milk fat) with disrupted MFGM. One sandwich for breakfast and one sandwich for lunch.

Dietary Supplement
  • Sandwich with butter-like dairy product (40g milk fat) with disrupted MFGM.

Sandwich with butter-like dairy product (40g milk fat) without MFGM. One sandwich for breakfast and one sandwich for lunch.

Dietary Supplement
  • Sandwich with butter-like dairy product (40g milk fat) without MFGM.

Primary outcomes

  1. Difference in postprandial triglycerides measured as area under the curve (AUC).

    Time frame: -60 to 180 minutes after first intervention (first meal), 0-180 minuter after second intervention (second high-fat meal)

    Difference in triglycerides AUC after the intervention between high-fat meal with intact MFGM, high-fat meal with destroyed MFGM, and high-fat meal without MFGM.

Secondary outcomes

  1. Difference in concentration of GLP-1

    Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)

  2. Difference in concentration of Ghrelin

    Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)

  3. Difference in concentration of LEAP2

    Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)

  4. Difference in concentration of FFA

    Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)

  5. Difference in concentration of Insulin

    Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)

  6. Difference in concentration of glucagon

    Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)

  7. Difference in concentration of cholesterol (total, LDL and HDL)

    Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)

  8. Difference in concentration of GIP

    Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)

  9. Difference in concentration of CCK

    Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)

  10. Difference in concentration concentration of Gastrin

    Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)

  11. Difference in concentration concentration of GDF15

    Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)

  12. Difference in concentration of LPS-BP (Lipopolysaccharide Binding Protein)

    Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)

  13. Difference in concentration concentration of Cytokines

    Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)

  14. Difference in concentration of apoB48

    Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)

  15. Difference in concentration of apoB100

    Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)

  16. Difference in glucose concentration

    Time frame: -60 to 360 minutes after first intervention (first high-fat meal)

    Continuous glucose monitoring (CGM)

  17. Difference in appetite sensation

    Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)

    Visual analogue scale (VAS)

  18. Difference in gastric emptying rate

    Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)

    Acetaminophen test

  19. Ad libitum meal test

    Time frame: 420 minutes after start of test day.

    Amount of food (in grams) intake at the end of the test day to measure if MFGM content and intactness influences ad libitum intake of calories at the next meal.

  20. Metabolic rate

    Time frame: 0-420 minutes

    Indirect calorimetry

  21. Substrate metabolism

    Time frame: 0-420 minutes

    Indirect calorimetry

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Arla Foods

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 1, 2024
Registry last updated
Mar 6, 2025

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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