Clinical trial NCT06953232: Acute Impact of Whey Protein-enriched Milk Fat Globule Membrane Supplementation on Postprandial Markers of Heart and Brain Health
Official title: Acute Impact of Whey Protein-enriched Milk Fat Globule Membrane Supplementation on Postprandial Markers of Heart and Brain Health in Postmenopausal Women Living With Overweight and at Moderate Risk for Cardiovascular Disease.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Cognition
Overweight or Obesity
Postmenopausal Women
Cardiometabolic Risk Factors
Keywords: Milk fat globule membrane
Milk polar lipids
triacylglycerol
postprandial
cholesterol
cardiometabolic disease risk
cognitive function
Lead sponsor: Loughborough University
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 16
Sex: FEMALE
Minimum age (years): 50
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 single-blind, randomised, placebo-controlled crossover manner, this study aims to assess the impact of a high-fat mixed meal containing a whey protein (WP)-enriched milk fat globule membrane (MFGM) powdered ingredient on markers of heart and brain health in the fed state among middle-to-older-aged, postmenopausal women living with overweight and at moderate risk for cardiovascular disease.

Participants will attend two \~8 hour study visits, where they will consume a high-fat meal containing a WP-enriched MFGM powdered ingredient or a placebo WP-based powdered ingredient. Each visit will involve anthropometric measurements and periodic assessments of heart health, including blood pressure and blood vessel stiffness measurements, blood sample collections, as well as computer-based tests measuring mood and cognition (brain function) over a 6-hour postprandial period.


Eligibility criteria: Inclusion Criteria:

* Apparently healthy postmenopausal women (not menstruating for 12 or more months)
* Aged 50 - 70 years
* BMI: 25 - 40 kg/m²
* Moderate CVD risk
* Recreationally active (\> 3 x 30 min moderate exercise per week)
* Understands and is willing and able to comply with all study procedures including eating a high-fat breakfast meal
* Fluent in written and spoken English
* Access to, and able to use, the internet/computer/tablet device

Exclusion Criteria:

* Smoking (including vaping)
* 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 e.g., diabetes, digestive, cancer or thyroidal disease, neurological disease (Alzheimer's disease, other form of dementia, mild cognitive impairment), or serious mental illness know to affect cognition (schizophrenia, schizoaffective disorder, bipolar disorder), learning disorders (dyslexia)
* Early or premature menopause resulting from medical conditions or undergoing surgery
* Hormone replacement therapy within last 6 months
* Prescribed medications likely to interfere with study outcomes (including lipid/cholesterol-lowering medications, including statins; blood thinners, antiplatelets (anticoagulants) such as heparin, etc.; medications for blood pressure; inflammation such as nonsteroidal anti-inflammatory drugs, aspirin, etc.; immune function, or lipid/carbohydrate metabolism) or prescribed antibiotics within the last three months
* Use of antidepressant or anti-anxiety medication if it has changed in the last three months or expected to change within the 3-month study period
* Taking vitamin, mineral, or fatty acid supplements (e.g., fish oil, calcium) or unwilling stop consuming these for the duration of the study (including sufficient washout period)
* Working night shifts
* Inaccessible veins for blood collection via cannulation
* Unstable weight history (≥3 kg loss or gain in the previous 3 months) or planning or currently on a weight reduction scheme
* Known allergy or intolerance to study food (including lactose intolerance, dairy, and wheat)
* 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 (i.e., more than 10 and a half pints of beer or 21 small glasses of wine)
* Currently taking part or have participated in another research study in the last two months (e.g., dietary intervention)

Primary outcomes:
measure: Postprandial change in circulating triacylglycerol response, assessed by iAUC 0-360 min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Secondary outcomes:
measure: Postprandial change in circulating triacylglycerol response, assessed via AUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating triacylglycerol response, assessed via Cₘₐₓ.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating triacylglycerol response, assessed via Tₘₐₓ.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating triacylglycerol response, assessed via time-course profile.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating lipid and apolipoprotein responses, assessed via AUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating lipid and apolipoprotein responses, assessed via iAUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating lipid and apolipoprotein responses, assessed via Cₘₐₓ.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating lipid and apolipoprotein responses, assessed via Tₘₐₓ.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating lipid and apolipoprotein responses, assessed via time-course profiles.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via AUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via iAUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via Cₘₐₓ.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via Tₘₐₓ.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via time-course profiles.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating apolipoprotein B48 response, assessed via AUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating apolipoprotein B48 response, assessed via iAUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating apolipoprotein B48 response, assessed via time-course profile.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating glucose response, assessed via AUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating glucose response, assessed via iAUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating glucose response, assessed via Cₘₐₓ.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating glucose response, assessed via Tₘₐₓ.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating glucose response, assessed via timecourse profile.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating insulin response, assessed via AUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating insulin response, assessed via iAUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating insulin response, assessed via Cₘₐₓ.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating insulin response, assessed via Tₘₐₓ.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating insulin response, assessed via timecourse profile.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating interleukin-6 response, assessed via AUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating interleukin-6 response, assessed via iAUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating interleukin-6 response, assessed via time-course profile.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating soluble CD14 response, assessed via AUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating soluble CD14 response, assessed via iAUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating soluble CD14 response, assessed via time-course profile.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating lipopolysaccharide-binding protein response, assessed via AUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating lipopolysaccharide-binding protein response, assessed via iAUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in circulating lipopolysaccharide-binding protein response, assessed via time-course profile.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in responses of selected circulating gut-related metabolite (for example, trimethylamine N-oxide, and short-chain fatty acids), assessed via AUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in responses of selected circulating gut-related metabolite (for example, trimethylamine N-oxide, and short-chain fatty acids), assessed via iAUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in responses of selected circulating gut-related metabolite (for example, trimethylamine N-oxide, and short-chain fatty acids), assessed via time-course profiles.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in clinic systolic and diastolic blood pressure, assessed via AUC₀-₃₆₀min.
timeFrame: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in clinic systolic and diastolic blood pressure, assessed via iAUC₀-₃₆₀min.
timeFrame: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in clinic systolic and diastolic blood pressure, assessed via time-course profiles.
timeFrame: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in markers of arterial stiffness including augmentation index and augmentation index adjusted to a standard heart rate of 75 bpm, assessed via AUC₀-₃₆₀min.
timeFrame: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in markers of arterial stiffness including augmentation index and augmentation index adjusted to a standard heart rate of 75 bpm, assessed via iAUC₀-₃₆₀min.
timeFrame: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in markers of arterial stiffness including augmentation index and augmentation index adjusted to a standard heart rate of 75 bpm, assessed via time-course profiles.
timeFrame: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in cognitive test performance.
timeFrame: Test battery will be completed at 0 (baseline) and 240 minutes (after meal ingestion)
measure: Postprandial change in mood.
timeFrame: Questionnaire will be completed at 0 (baseline) and 240 minutes (after meal ingestion)
measure: Postprandial change in responses of selected circulating biomarkers of cognitive health/neuroinflammation (for example, brain-derived neurotrophic factor), assessed via AUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in responses of selected circulating biomarkers of cognitive health/neuroinflammation (for example, brain-derived neurotrophic factor), assessed via iAUC₀-₃₆₀min.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
measure: Postprandial change in responses of selected circulating biomarkers of cognitive health/neuroinflammation (for example, brain-derived neurotrophic factor), assessed via time-course profiles.
timeFrame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
state: Leicestershire
Study officials:
References: