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

NCT ID: NCT06953232

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-07-31

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.

Conditions

Cardiovascular Diseases; Cognition; Overweight or Obesity; Postmenopausal Women; Cardiometabolic Risk Factors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Whey protein-enriched milk fat globule membrane 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.

Group Type: EXPERIMENTAL

Whey protein-enriched milk fat globule membrane supplement

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Whey protein-based supplement

Intervention Type: 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.

Interventions

Whey protein-enriched milk fat globule membrane 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.

Intervention Type: DIETARY_SUPPLEMENT

Whey protein-based 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Placebo

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Loughborough University

OTHER

Sponsor Role: lead

Responsible Party

Dr Oonagh Markey

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Loughborough University

Loughborough, Leicestershire, United Kingdom

Countries

United Kingdom

Central Contacts

Oonagh Markey, BSc, PhD

Role: CONTACT

o.markey@lboro.ac.uk

+44 1509 222737

Aishwarya Borkar, BSc, MSc

Role: CONTACT

a.s.borkar@lboro.ac.uk

Facility Contacts

Oonagh Markey

Role: primary

o.markey@lboro.ac.uk

Other Identifiers

Project ID: 18721

Identifier Type: -

Identifier Source: org_study_id