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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-75
SponsorLoughborough University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Apparently healthy postmenopausal women (not menstruating for 12 or more months)

Aged 50 - 75 years

BMI: 25 - 40 kg/m²

Moderate CVD risk

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: Whey protein-enriched milk fat globule membrane supplementExperimental treatment 1 intervention
Group B: Whey protein-based supplementPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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)
2

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)
3

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)
4

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)

Other outcomes

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