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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey protein-enriched milk fat globule membrane supplement | Experimental | 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. |
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| Whey protein-based supplement | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein-enriched milk fat globule membrane supplement | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial change in circulating triacylglycerol response, assessed by iAUC 0-360 min. | Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform. | Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion) |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial change in circulating triacylglycerol response, assessed via AUC₀-₃₆₀min. | Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oonagh Markey, BSc, PhD | Contact | +44 1509 222737 | o.markey@lboro.ac.uk | |
| Aishwarya Borkar, BSc, MSc | Contact | a.s.borkar@lboro.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loughborough University | Recruiting | Loughborough | Leicestershire | LE11 3TU | United Kingdom |
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Participants will be blinded to the assignment of intervention or control. Data analysis will be conducted in a blinded manner to reduce potential bias.
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| Whey protein-based supplement | Dietary 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. |
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Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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. | 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) | 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 | 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 | 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 | Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion) |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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