Clinical trial NCT05939544: Impact of Milk Fat Globule Membrane Supplementation on Heart and Brain Health
Official title: Impact of Short-term Supplementation with a Milk Fat Globule Membrane-enriched Powdered Ingredient on Cardiometabolic and Cognitive Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Overweight and Obesity
Cognition
Keywords: milk fat globule membrane
milk polar lipids
cholesterol
cardiometabolic risk
Lead sponsor: Loughborough University
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change-from-baseline in circulating LDL-cholesterol concentrations
timeFrame: 28 days
Secondary outcomes:
measure: Change-from-baseline in circulating lipid and apolipoprotein concentrations (measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform)
timeFrame: 28 days
measure: Change-from-baseline in particle size of lipoprotein subclasses, and concentrations of particles within each subclass by high-throughput 1H-NMR metabolomics platform
timeFrame: 28 days
measure: Change-from-baseline in interleukin-6 concentrations (determined by ELISA)
timeFrame: 28 days
measure: Change-from-baseline in lipopolysaccharide-binding protein concentrations (determined by ELISA)
timeFrame: 28 days
measure: Change-from-baseline in selected gut-related metabolites (for example, trimethylamine N-oxide concentrations determined by mass spectrometry)
timeFrame: 28 days
measure: Change-from-baseline in glucose concentrations (determined by spectrophotometric assay)
timeFrame: 28 days
measure: Change-from-baseline in insulin concentrations (determined by ELISA)
timeFrame: 28 days
measure: Change-from-baseline in HOMA-IR (calculated as [fasting glucose (mmol/L) × fasting insulin (mIU/L)]/22.5])
timeFrame: 28 days
measure: Change-from-baseline in clinic systolic and diastolic blood pressure (assessed by automated upper arm sphygmomanometer)
timeFrame: 28 days
measure: Change-from-baseline in arterial stiffness, as assessed by radial pulse wave analysis (using applanation tonometry)
timeFrame: 28 days
measure: Change-from-baseline in forearm blood flow, as assessed by venous occlusion plethysmography (using applanation tonometry)
timeFrame: 28 days
measure: 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
timeFrame: 28 days
measure: Change-from-baseline in brain-derived neurotrophic factor concentrations (determined by ELISA)
timeFrame: 28 days
measure: Change-from-baseline in body mass (kg) using standard equipment.
timeFrame: 28 days
measure: Change-from-baseline in waist circumference (cm) using standard equipment.
timeFrame: 28 days
measure: Change-from-baseline in body fat (%) using standard equipment.
timeFrame: 28 days
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
Study officials:
References: