Impact of Milk Fat Globule Membrane Supplementation on Heart and Brain Health

• Sponsor: Loughborough University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05939544
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

In a randomised, controlled cross-over manner, this trial aims to determine how short-term daily supplementation with a milk fat globule membrane-enriched ingredient impacts on cardiometabolic health and cognitive outcomes.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases; Overweight and Obesity; Cognition	Dietary Supplement: Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient; Dietary Supplement: Placebo Comparator: Control (Placebo) Powdered Ingredient	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Impact of Short-term Supplementation With a Milk Fat Globule Membrane-enriched Powdered Ingredient on Cardiometabolic and Cognitive Health Outcomes
• Anticipated Study Start Date: Jul 10, 2023
• Anticipated Primary Completion Date: Mar 10, 2025
• Anticipated Study Completion Date: Mar 10, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient Participants will be provided with pre-weighed, foil sachets containing a ready-to-mix flavoured powdered supplement that is rich in milk fat globule membrane (and associated complex milk lipids). They will be asked to consume two sachets daily (mixed with water) during the 4-week study period. Sachets will be coded to maintain study blinding.	Dietary Supplement: Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient; Milk Fat Globule Membrane-enriched Powdered Ingredient
Placebo Comparator: Control (Placebo) Powdered Ingredient Participants will be provided with pre-weighed, foil sachets containing an energy- and macronutrient-matched ready-to-mix powdered placebo supplement that is devoid of milk fat globule membrane (and associated complex milk lipids). They will be asked to consume two sachets daily (mixed with water) during the 4-week study period. Sachets will be coded to maintain study blinding.	Dietary Supplement: Placebo Comparator: Control (Placebo) Powdered Ingredient; Placebo Comparator: Control (Placebo) Powdered Ingredient

Outcome Measures

Primary Outcome Measures

1. Change-from-baseline in circulating LDL-cholesterol concentrations [28 days]

   Assessed following the collection of fasted blood samples before and after each 28-day study period

Secondary Outcome Measures

1. Change-from-baseline in circulating lipid and apolipoprotein concentrations (measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform) [28 days]

   Assessed following the collection of fasted blood samples before and after each 28-day study period

2. Change-from-baseline in particle size of lipoprotein subclasses, and concentrations of particles within each subclass by high-throughput 1H-NMR metabolomics platform [28 days]

   Assessed following the collection of fasted blood samples before and after each 28-day study period

3. Change-from-baseline in interleukin-6 concentrations (determined by ELISA) [28 days]

   Assessed following the collection of fasted blood samples before and after each 28-day study period

4. Change-from-baseline in lipopolysaccharide-binding protein concentrations (determined by ELISA) [28 days]

   Assessed following the collection of fasted blood samples before and after each 28-day study period

5. Change-from-baseline in selected gut-related metabolites (for example, trimethylamine N-oxide concentrations determined by mass spectrometry) [28 days]

   Assessed following the collection of fasted blood samples before and after each 28-day study period

6. Change-from-baseline in glucose concentrations (determined by spectrophotometric assay) [28 days]

   Assessed following the collection of fasted blood samples before and after each 28-day study period

7. Change-from-baseline in insulin concentrations (determined by ELISA) [28 days]

   Assessed following the collection of fasted blood samples before and after each 28-day study period

8. Change-from-baseline in HOMA-IR (calculated as [fasting glucose (mmol/L) × fasting insulin (mIU/L)]/22.5]) [28 days]

   Assessed following assessment of fasting circulating glucose and insulin concentrations before and after each 28-day study period

9. Change-from-baseline in clinic systolic and diastolic blood pressure (assessed by automated upper arm sphygmomanometer) [28 days]

   Assessed in the fasted state before and after each 28-day study period

10. Change-from-baseline in arterial stiffness, as assessed by radial pulse wave analysis (using applanation tonometry) [28 days]

    Assessed in the fasted state before and after each 28-day study period

11. Change-from-baseline in forearm blood flow, as assessed by venous occlusion plethysmography (using applanation tonometry) [28 days]

    Assessed in the fasted state before and after each 28-day study period

12. Change-from-baseline in cognitive test performance using a neuropsychological seven-test battery which assesses global and domain specific function, as determined by NeurOn software [28 days]

    Assessed before and after each 28-day study period

13. Change-from-baseline in brain-derived neurotrophic factor concentrations (determined by ELISA) [28 days]

    Assessed in the fasted state before and after each 28-day study period

14. Change-from-baseline in body mass (kg) using standard equipment. [28 days]

    Assessed in the fasted state before and after each 28-day study period

15. Change-from-baseline in waist circumference (cm) using standard equipment. [28 days]

    Assessed in the fasted state before and after each 28-day study period

16. Change-from-baseline in body fat (%) using standard equipment. [28 days]

    Assessed in the fasted state before and after each 28-day study period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Aged 40 - 70 years

• BMI: 25-45 kg/m2

• Recreationally active (> 3 x 30 min moderate exercise per week)

• Understands and is willing and able to comply with all study procedures, including changes to diet

• Fluent in written and spoken English

• Access to, and able to use, the internet/computer/tablet device

Exclusion Criteria:

• Smoking (including vaping)

• Unstable weight history (≥3 kg loss or gain in the previous 3 months) or planning or currently on a weight reduction scheme

• Currently taking part or have participated in another research study in the last two months (e.g., dietary intervention)

• Diagnosed with cardiovascular disease or suffered myocardial infarction/stroke in the past twelve months

• Existing or significant past medical history of any medical condition likely to affect the study outcomes.

• Prescribed medications or supplements likely to interfere with study outcomes or prescribed antibiotics within the last three months

• Use of antidepressant/anti-anxiety medication if it has changed in the last three months or expected to change within the 3-month study period.

• Known allergy or intolerance to study food (lactose intolerance, dairy)

• Being vegan or any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention or metabolic study

• Excessive alcohol consumption: >21 unit/wk

• Pregnancy, seeking to become pregnant or active lactation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loughborough University	Loughborough		United Kingdom	LE11 3TU

Sponsors and Collaborators

• Loughborough University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Oonagh Markey, Principal Investigator, Loughborough University
• ClinicalTrials.gov Identifier: NCT05939544
• Other Study ID Numbers: 10260
• First Posted: Jul 11, 2023
• Last Update Posted: Jul 13, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr Oonagh Markey, Principal Investigator, Loughborough University: milk fat globule membrane; milk polar lipids; cholesterol; cardiometabolic risk
• Additional relevant MeSH terms: Cardiovascular Diseases; Overweight; Milk fat globule

Study Results

No Results Posted as of Jul 13, 2023