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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiovascular Diseases, Overweight and Obesity, Cognition

Intervention / Treatment
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* Dietary Supplement: Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient
* Dietary Supplement: Placebo Comparator: Control (Placebo) Powdered Ingredient


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient<br>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<br>* Milk Fat Globule Membrane-enriched Powdered Ingredient<br>|
| Placebo Comparator: Control (Placebo) Powdered Ingredient<br>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<br>* Placebo Comparator: Control (Placebo) Powdered Ingredient<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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milk fat globule membrane, milk polar lipids, cholesterol, cardiometabolic risk