Impact of Milk Fat Globule Membrane Supplementation on Heart and Brain Health
- Conditions
- Overweight and ObesityCognitionCardiovascular Diseases
- Registration Number
- NCT05939544
- Lead Sponsor
- Loughborough University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
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 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 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 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 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 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 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 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 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 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 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 body fat (%) using standard equipment. 28 days Assessed in the fasted state before and after each 28-day study period
Trial Locations
- Locations (1)
Loughborough University
🇬🇧Loughborough, United Kingdom