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

NCT06340412 | Completed

• 1 other identifier: MFGM-FOR-HEALTH
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postprandial Lipid Metabolism

Keywords

Milk fat globule membrane

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (21)

• Difference in concentration of GLP-1

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

• Difference in concentration of Ghrelin

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

• Difference in concentration of LEAP2

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

• Difference in concentration of FFA

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

• Difference in concentration of Insulin

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

Study Arms (3)

High-fat meal with intact MFGM

EXPERIMENTAL

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

High-fat meal with destroyed MFGM

EXPERIMENTAL

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

High-fat meal without MFGM

EXPERIMENTAL

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

Interventions

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

1\) Sandwich with butter-like dairy product (40g milk fat) with intact MFGM.

High-fat meal 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

2\) Sandwich with butter-like dairy product (40g milk fat) with disrupted MFGM.

High-fat meal with destroyed MFGM

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

3\) Sandwich with butter-like dairy product (40g milk fat) without MFGM.

High-fat meal without MFGM

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years
• Written and informed consent
• HbA1c \< 48 mmol/l

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Arla Foods: collaborator

Study Sites (1)

Steno Diabetes Center Aarhus, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Interventions

Breakfast; Lunch

Intervention Hierarchy (Ancestors)

Meals; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Esben Søndergaard, MD, PhD

  Steno Diabetes Center Aarhus, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, double-blinded, controlled, crossover trial

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: April 1, 2024
• Study Start: March 11, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: March 6, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)