Impact of Milk Fat Globule Membrane Supplementation on Heart and Brain Health

Cardiovascular Diseases Clinical Trial

Official title:

Impact of Short-term Supplementation With a Milk Fat Globule Membrane-enriched Powdered Ingredient on Cardiometabolic and Cognitive Health Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939544
• Other study ID #: 10260
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: March 10, 2025

Study information

• Verified date: October 2023
• Source: Loughborough University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In a randomised, controlled cross-over manner, this trial aims to determine how short-term daily supplementation with a milk fat globule membrane-enriched ingredient impacts on cardiometabolic health and cognitive outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17
• Est. completion date: March 10, 2025
• Est. primary completion date: March 10, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Aged 40 - 70 years
• BMI: 25-45 kg/m2
• Recreationally active (> 3 x 30 min moderate exercise per week)
• Understands and is willing and able to comply with all study procedures, including changes to diet
• Fluent in written and spoken English
• Access to, and able to use, the internet/computer/tablet device

Exclusion Criteria:

• Smoking (including vaping)
• Unstable weight history (=3 kg loss or gain in the previous 3 months) or planning or currently on a weight reduction scheme
• Currently taking part or have participated in another research study in the last two months (e.g., dietary intervention)
• 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.
• Prescribed medications or supplements likely to interfere with study outcomes or prescribed antibiotics within the last three months
• Use of antidepressant/anti-anxiety medication if it has changed in the last three months or expected to change within the 3-month study period.
• Known allergy or intolerance to study food (lactose intolerance, dairy)
• 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
• Pregnancy, seeking to become pregnant or active lactation

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cognition
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient
Milk Fat Globule Membrane-enriched Powdered Ingredient
• Placebo Comparator: Control (Placebo) Powdered Ingredient
Placebo Comparator: Control (Placebo) Powdered Ingredient

Locations

Country	Name	City	State
United Kingdom	Loughborough University	Loughborough

Sponsors (1)

Lead Sponsor	Collaborator
Loughborough University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change-from-baseline in circulating LDL-cholesterol concentrations	Assessed following the collection of fasted blood samples before and after each 28-day study period	28 days
Secondary	Change-from-baseline in circulating lipid and apolipoprotein concentrations (measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform)	Assessed following the collection of fasted blood samples before and after each 28-day study period	28 days
Secondary	Change-from-baseline in particle size of lipoprotein subclasses, and concentrations of particles within each subclass by high-throughput 1H-NMR metabolomics platform	Assessed following the collection of fasted blood samples before and after each 28-day study period	28 days
Secondary	Change-from-baseline in interleukin-6 concentrations (determined by ELISA)	Assessed following the collection of fasted blood samples before and after each 28-day study period	28 days
Secondary	Change-from-baseline in lipopolysaccharide-binding protein concentrations (determined by ELISA)	Assessed following the collection of fasted blood samples before and after each 28-day study period	28 days
Secondary	Change-from-baseline in selected gut-related metabolites (for example, trimethylamine N-oxide concentrations determined by mass spectrometry)	Assessed following the collection of fasted blood samples before and after each 28-day study period	28 days
Secondary	Change-from-baseline in glucose concentrations (determined by spectrophotometric assay)	Assessed following the collection of fasted blood samples before and after each 28-day study period	28 days
Secondary	Change-from-baseline in insulin concentrations (determined by ELISA)	Assessed following the collection of fasted blood samples before and after each 28-day study period	28 days
Secondary	Change-from-baseline in HOMA-IR (calculated as [fasting glucose (mmol/L) × fasting insulin (mIU/L)]/22.5])	Assessed following assessment of fasting circulating glucose and insulin concentrations before and after each 28-day study period	28 days
Secondary	Change-from-baseline in clinic systolic and diastolic blood pressure (assessed by automated upper arm sphygmomanometer)	Assessed in the fasted state before and after each 28-day study period	28 days
Secondary	Change-from-baseline in arterial stiffness, as assessed by radial pulse wave analysis (using applanation tonometry)	Assessed in the fasted state before and after each 28-day study period	28 days
Secondary	Change-from-baseline in forearm blood flow, as assessed by venous occlusion plethysmography (using applanation tonometry)	Assessed in the fasted state before and after each 28-day study period	28 days
Secondary	Change-from-baseline in cognitive test performance using a neuropsychological seven-test battery which assesses global and domain specific function, as determined by NeurOn software	Assessed before and after each 28-day study period	28 days
Secondary	Change-from-baseline in brain-derived neurotrophic factor concentrations (determined by ELISA)	Assessed in the fasted state before and after each 28-day study period	28 days
Secondary	Change-from-baseline in body mass (kg) using standard equipment.	Assessed in the fasted state before and after each 28-day study period	28 days
Secondary	Change-from-baseline in waist circumference (cm) using standard equipment.	Assessed in the fasted state before and after each 28-day study period	28 days
Secondary	Change-from-baseline in body fat (%) using standard equipment.	Assessed in the fasted state before and after each 28-day study period	28 days