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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
18
Milk Fat Globule Membrane-enriched Powdered Ingredient
Placebo Comparator: Control (Placebo) Powdered Ingredient
Loughborough University
Loughborough, United Kingdom
Change-from-baseline in circulating LDL-cholesterol concentrations
Assessed following the collection of fasted blood samples before and after each 28-day study period
Time frame: 28 days
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 28 days
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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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 28 days
Change-from-baseline in body fat (%) using standard equipment.
Assessed in the fasted state before and after each 28-day study period
Time frame: 28 days