Cardiovascular Diseases, Cognition, Overweight and Obesity
Conditions
Keywords
milk fat globule membrane, milk polar lipids, cholesterol, cardiometabolic risk
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.
Interventions
DIETARY_SUPPLEMENTExperimental: Milk Fat Globule Membrane-enriched Powdered Ingredient
Milk Fat Globule Membrane-enriched Powdered Ingredient
DIETARY_SUPPLEMENTPlacebo Comparator: Control (Placebo) Powdered Ingredient
Placebo Comparator: Control (Placebo) Powdered Ingredient
Sponsors
Loughborough University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change-from-baseline in body fat (%) using standard equipment. | 28 days | Assessed in the fasted state before and after each 28-day study period |
| 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 |
Countries
United Kingdom
Outcome results
None listed