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

Official title

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.

Overview

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.

Interventions

• Dietary supplement 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.
• 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.

Primary outcome measures

• Postprandial change in circulating triacylglycerol response, assessed by iAUC 0-360 min. [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 outcome measures (12)

• Postprandial change in circulating triacylglycerol response, assessed via AUC₀-₃₆₀min. [Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)]
• Postprandial change in circulating triacylglycerol response, assessed via Cₘₐₓ. [Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)]
• Postprandial change in circulating triacylglycerol response, assessed via Tₘₐₓ. [Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)]
• Postprandial change in circulating triacylglycerol response, assessed via time-course profile. [Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)]
• Postprandial change in circulating lipid and apolipoprotein responses, assessed via AUC₀-₃₆₀min. [Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)]
• Postprandial change in circulating lipid and apolipoprotein responses, assessed via iAUC₀-₃₆₀min. [Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)]
• Postprandial change in circulating lipid and apolipoprotein responses, assessed via Cₘₐₓ. [Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)]
• Postprandial change in circulating lipid and apolipoprotein responses, assessed via Tₘₐₓ. [Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)]
• Postprandial change in circulating lipid and apolipoprotein responses, assessed via time-course profiles. [Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)]
• Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via AUC₀-₃₆₀min. [Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)]
• Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via iAUC₀-₃₆₀min. [Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)]
• Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via Cₘₐₓ. [Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)]

Eligibility criteria

Inclusion 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

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Prevention

Study locations

United Kingdom · 1 center

• Loughborough University — Loughborough

Identifiers

NCT: NCT06953232 · Project ID: 18721

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗