Actively Recruiting

Phase Not Applicable
Age: 50Years - 75Years
FEMALE
Healthy Volunteers
ID06953232

Acute Impact of Whey Protein-enriched Milk Fat Globule Membrane Supplementation on Postprandial Markers of Heart and Brain Health in Postmenopausal Women Living With Overweight and at Moderate Risk for Cardiovascular Disease

Led by Loughborough University · Updated on 2026-05-20

16

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the effects of a high-fat mixed meal containing a whey protein-enriched milk fat globule membrane (MFGM) supplement on heart and brain health markers in middle-to-older-aged, postmenopausal women who are overweight and at moderate risk for cardiovascular disease. This randomized, single-blind, placebo-controlled crossover study aims to understand how this specific nutritional ingredient influences post-meal responses related to cardiovascular and cognitive health. Participants will attend two approximately 8-hour visits. During each visit, they will consume a high-fat meal containing about 75 grams of refined palm oil fat supplemented either with a whey protein-enriched MFGM powdered ingredient or a placebo whey protein-based powdered ingredient without MFGM. The meals are matched for energy and protein content and given in random order with a washout period of at least 21 days between visits. During each visit, researchers will take body measurements and periodically assess heart health through blood pressure and blood vessel stiffness tests. Blood samples will be collected at multiple time points before and after the meal, over a 6-hour period, to measure changes in blood fats, glucose, insulin, and inflammatory markers. Participants will also complete computer-based tests to assess mood and cognitive function. The study will monitor how the supplement affects these heart and brain health markers in the hours following a meal.

CONDITIONS

Brief 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 to 75 years
  • Body mass index (BMI) between 25 and 40 kg/m²
  • Moderate cardiovascular disease risk
  • Recreationally active with more than 3 sessions of 30 minutes moderate exercise per week
  • Able and willing 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, or tablet device
Not Eligible

You will not qualify if you...

  • Current smoking or vaping
  • Diagnosed cardiovascular disease or heart attack/stroke in the past 12 months
  • Significant medical history affecting study outcomes (e.g., diabetes, digestive, cancer, thyroid disease, neurological or serious mental illness affecting cognition, learning disorders)
  • Early or premature menopause due to medical conditions or surgery
  • Hormone replacement therapy in the last 6 months
  • Use of medications that may interfere with study outcomes or antibiotics in the last 3 months
  • Recent change or expected change in antidepressant or anti-anxiety medication
  • Taking vitamin, mineral, or fatty acid supplements unwilling to stop during the study
  • Working night shifts
  • Difficulties with vein access for blood collection
  • Unstable weight or current/planned weight loss scheme
  • Allergy or intolerance to study foods (including lactose, dairy, wheat)
  • Vegan or unusual diet or lifestyle that prevents participation in dietary studies
  • Excessive alcohol intake (>21 units per week)
  • Participation in another research study in the last 2 months

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - At least 6 weeks including washout period

Participants consume two high-fat mixed meals containing either a whey protein-enriched milk fat globule membrane supplement or a whey protein-based supplement without milk fat globule membrane, administered in random order with a washout period between sessions.

2 visits with at least 21 days washout between each (in-person)

Post-treatment Monitoring

Duration - 6 hours per visit

Participants undergo postprandial measurements of blood markers, blood pressure, cognitive tests, and mood assessments over 6 hours after each meal ingestion to evaluate heart and brain health responses.

2 visits (in-person) with multiple blood draws and assessments over 6 hours each

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

A

Aishwarya Borkar, BSc, MSc

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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