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New treatment option for Cardiovascular Diseases
Official title Acute Impact of Whey Protein-enriched Milk Fat Globule Membrane Supplementation on Postprandial Markers of Heart and Brain Health
ClinicalTrials.gov ID: NCT06953232
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 75, women only. Healthy volunteers may be eligible.
You may be able to join if
- Apparently healthy postmenopausal women (not menstruating for 12 or more months)
- Aged 50 - 75 years
- BMI: 25 - 40 kg/m²
- Moderate CVD risk
- Recreationally active (\> 3 x 30 min moderate exercise per week)
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- Apparently healthy postmenopausal women (not menstruating for 12 or more months)
- Aged 50 - 75 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
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Loughborough, Leicestershire, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 50 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loughborough, Leicestershire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.