Actively Recruiting

Phase Not Applicable
Age: 50Years - 75Years
FEMALE
Healthy Volunteers
NCT06953232

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

Led by Loughborough University · Updated on 2026-05-08

16

Participants Needed

1

Research Sites

39 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 50Years - 75Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Apparently healthy postmenopausal women (not menstruating for 12 or more months)
  • Aged 50 - 75 years
  • BMI: 25 - 40 kg/m8
  • 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
Not Eligible

You will not qualify if you...

  • 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 known 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)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Loughborough University

Loughborough, Leicestershire, United Kingdom, LE11 3TU

Actively Recruiting

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Research Team

O

Oonagh Markey, BSc, PhD

CONTACT

A

Aishwarya Borkar, BSc, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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