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

Impact of Short-term Supplementation With a Milk Fat Globule Membrane-enriched Powdered Ingredient on Cardiometabolic and Cognitive Health Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Overweight and Obesity; Cognition
• Intervention / Treatment: Dietary supplement: Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient; Dietary supplement: Placebo Comparator: Control (Placebo) Powdered Ingredient

• Study Type: Interventional
• Enrollment (Estimated): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Loughborough, United Kingdom, LE11 3TU
    • Recruiting
    • Loughborough University
    • Contact: Oonagh Markey, BSc, PhD; Phone Number: +44 1509 222737; Email: o.markey@lboro.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change-from-baseline in circulating LDL-cholesterol concentrations	Assessed following the collection of fasted blood samples before and after each 28-day study period	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change-from-baseline in circulating lipid and apolipoprotein concentrations (measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform)	Assessed following the collection of fasted blood samples before and after each 28-day study period	28 days
Change-from-baseline in particle size of lipoprotein subclasses, and concentrations of particles within each subclass by high-throughput 1H-NMR metabolomics platform	Assessed following the collection of fasted blood samples before and after each 28-day study period	28 days
Change-from-baseline in interleukin-6 concentrations (determined by ELISA)	Assessed following the collection of fasted blood samples before and after each 28-day study period	28 days
Change-from-baseline in lipopolysaccharide-binding protein concentrations (determined by ELISA)	Assessed following the collection of fasted blood samples before and after each 28-day study period	28 days
Change-from-baseline in selected gut-related metabolites (for example, trimethylamine N-oxide concentrations determined by mass spectrometry)	Assessed following the collection of fasted blood samples before and after each 28-day study period	28 days
Change-from-baseline in glucose concentrations (determined by spectrophotometric assay)	Assessed following the collection of fasted blood samples before and after each 28-day study period	28 days
Change-from-baseline in insulin concentrations (determined by ELISA)	Assessed following the collection of fasted blood samples before and after each 28-day study period	28 days
Change-from-baseline in HOMA-IR (calculated as [fasting glucose (mmol/L) × fasting insulin (mIU/L)]/22.5])	Assessed following assessment of fasting circulating glucose and insulin concentrations before and after each 28-day study period	28 days
Change-from-baseline in clinic systolic and diastolic blood pressure (assessed by automated upper arm sphygmomanometer)	Assessed in the fasted state before and after each 28-day study period	28 days
Change-from-baseline in arterial stiffness, as assessed by radial pulse wave analysis (using applanation tonometry)	Assessed in the fasted state before and after each 28-day study period	28 days
Change-from-baseline in forearm blood flow, as assessed by venous occlusion plethysmography (using applanation tonometry)	Assessed in the fasted state before and after each 28-day study period	28 days
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	Assessed before and after each 28-day study period	28 days
Change-from-baseline in brain-derived neurotrophic factor concentrations (determined by ELISA)	Assessed in the fasted state before and after each 28-day study period	28 days
Change-from-baseline in body mass (kg) using standard equipment.	Assessed in the fasted state before and after each 28-day study period	28 days
Change-from-baseline in waist circumference (cm) using standard equipment.	Assessed in the fasted state before and after each 28-day study period	28 days
Change-from-baseline in body fat (%) using standard equipment.	Assessed in the fasted state before and after each 28-day study period	28 days

Collaborators and Investigators

• Sponsor: Loughborough University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Estimated): March 10, 2025
• Study Completion (Estimated): March 10, 2025

Study Registration Dates

• First Submitted: June 23, 2023
• First Submitted That Met QC Criteria: July 1, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: cardiometabolic risk; cholesterol; milk fat globule membrane; milk polar lipids
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Cardiovascular Diseases; Overweight; Anti-Infective Agents; Milk fat globule
• Other Study ID Numbers: 10260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No