Acute Impact of Whey Protein-enriched Milk Fat Globule Membrane Supplementation on Postprandial Markers of Heart and Brain Health

N/ANot Yet RecruitingNCT06953232

Loughborough University16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Cardiovascular Diseases Cognition Overweight or Obesity

Interventions

Whey protein-enriched milk fat globule membrane supplementDIETARY_SUPPLEMENT

Participants will consume a high-fat, mixed meal containing approximately 75 g of test fat (refined palm oil), supplemented with a whey protein-enriched milk fat globule membrane (providing \~5 g of milk polar lipids) powdered ingredient. The experimental and placebo meals will be isoenergetic and protein-matched, and will be administered in a randomised order, with a washout period of at least 21 days between sessions.

Whey protein-based supplementDIETARY_SUPPLEMENT

Participants will consume a high-fat, mixed meal containing approximately 75 g of test fat (refined palm oil) supplemented with a whey protein-based powdered ingredient without milk fat globule membrane (placebo) The experimental and placebo meals will be isoenergetic and protein-matched, and will be administered in a randomised order, with a washout period of at least 21 days between sessions.

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Postprandial change in circulating triacylglycerol response, assessed by iAUC 0-360 min.

Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Secondary Outcomes

Postprandial change in circulating triacylglycerol response, assessed via AUC₀-₃₆₀min.

Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating triacylglycerol response, assessed via Cₘₐₓ.

Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating triacylglycerol response, assessed via Tₘₐₓ.

Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating triacylglycerol response, assessed via time-course profile.

Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating lipid and apolipoprotein responses, assessed via AUC₀-₃₆₀min.

Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating lipid and apolipoprotein responses, assessed via iAUC₀-₃₆₀min.

Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating lipid and apolipoprotein responses, assessed via Cₘₐₓ.

Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating lipid and apolipoprotein responses, assessed via Tₘₐₓ.

Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating lipid and apolipoprotein responses, assessed via time-course profiles.

Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via AUC₀-₃₆₀min.

Assessed using high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via iAUC₀-₃₆₀min.

Assessed using high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via Cₘₐₓ.

Assessed using high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via Tₘₐₓ.

Assessed using high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via time-course profiles.

Assessed using high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating apolipoprotein B48 response, assessed via AUC₀-₃₆₀min.

Determined by ELISA.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in circulating apolipoprotein B48 response, assessed via iAUC₀-₃₆₀min.

Determined by ELISA.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in circulating apolipoprotein B48 response, assessed via time-course profile.

Determined by ELISA.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in circulating glucose response, assessed via AUC₀-₃₆₀min.

Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating glucose response, assessed via iAUC₀-₃₆₀min.

Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating glucose response, assessed via Cₘₐₓ.

Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating glucose response, assessed via Tₘₐₓ.

Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating glucose response, assessed via timecourse profile.

Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating insulin response, assessed via AUC₀-₃₆₀min.

Determined by ELISA.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating insulin response, assessed via iAUC₀-₃₆₀min.

Determined by ELISA.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating insulin response, assessed via Cₘₐₓ.

Determined by ELISA.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating insulin response, assessed via Tₘₐₓ.

Determined by ELISA.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating insulin response, assessed via timecourse profile.

Determined by ELISA.

Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Postprandial change in circulating interleukin-6 response, assessed via AUC₀-₃₆₀min.

Determined by ELISA

Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in circulating interleukin-6 response, assessed via iAUC₀-₃₆₀min.

Determined by ELISA

Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in circulating interleukin-6 response, assessed via time-course profile.

Determined by ELISA

Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in circulating soluble CD14 response, assessed via AUC₀-₃₆₀min.

Determined by ELISA

Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in circulating soluble CD14 response, assessed via iAUC₀-₃₆₀min.

Determined by ELISA

Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in circulating soluble CD14 response, assessed via time-course profile.

Determined by ELISA

Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in circulating lipopolysaccharide-binding protein response, assessed via AUC₀-₃₆₀min.

Determined by ELISA

Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in circulating lipopolysaccharide-binding protein response, assessed via iAUC₀-₃₆₀min.

Determined by ELISA

Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in circulating lipopolysaccharide-binding protein response, assessed via time-course profile.

Determined by ELISA

Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in responses of selected circulating gut-related metabolite (for example, trimethylamine N-oxide, and short-chain fatty acids), assessed via AUC₀-₃₆₀min.

Determined by ELISA

Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in responses of selected circulating gut-related metabolite (for example, trimethylamine N-oxide, and short-chain fatty acids), assessed via iAUC₀-₃₆₀min.

Determined by ELISA

Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

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.

Determined by ELISA

Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in clinic systolic and diastolic blood pressure, assessed via AUC₀-₃₆₀min.

Determined by automated upper arm sphygmomanometer

Time frame: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in clinic systolic and diastolic blood pressure, assessed via iAUC₀-₃₆₀min.

Determined by automated upper arm sphygmomanometer

Time frame: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in clinic systolic and diastolic blood pressure, assessed via time-course profiles.

Determined by automated upper arm sphygmomanometer

Time frame: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

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.

Determined by radial pulse wave analysis (using applanation tonometry)

Time frame: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

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.

Determined by radial pulse wave analysis (using applanation tonometry)

Time frame: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

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.

Determined by radial pulse wave analysis (using applanation tonometry)

Time frame: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in cognitive test performance.

Cognition will be assessed using a neuropsychological nine-test battery which assesses global and domain-specific function, as determined by NeurOn software.

Time frame: Test battery will be completed at 0 (baseline) and 240 minutes (after meal ingestion)

Postprandial change in mood.

Determined by the Bond-Lader visual analogue scale (includes 16 items each having antonyms on two ends, on a scale of 1 to 100, 50 being the neutral point)

Time frame: Questionnaire will be completed at 0 (baseline) and 240 minutes (after meal ingestion)

Postprandial change in responses of selected circulating biomarkers of cognitive health/neuroinflammation (for example, brain-derived neurotrophic factor), assessed via AUC₀-₃₆₀min.

Determined by ELISA

Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in responses of selected circulating biomarkers of cognitive health/neuroinflammation (for example, brain-derived neurotrophic factor), assessed via iAUC₀-₃₆₀min.

Determined by ELISA

Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Postprandial change in responses of selected circulating biomarkers of cognitive health/neuroinflammation (for example, brain-derived neurotrophic factor), assessed via time-course profiles.

Determined by ELISA

Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Acute Impact of Whey Protein-enriched Milk Fat Globule Membrane Supplementation on Postprandial Markers of Heart and Brain Health

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts