Back to resultsImpact of Milk Fat Globule Membrane Supplementation on Heart and Brain Health
Primary Purpose
Cardiovascular Diseases, Overweight and Obesity, Cognition
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient
Placebo Comparator: Control (Placebo) Powdered Ingredient
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases focused on measuring milk fat globule membrane, milk polar lipids, cholesterol, cardiometabolic risk
Eligibility Criteria
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
Sites / Locations
- Loughborough UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Milk Fat Globule Membrane-enriched Powdered Ingredient
Control (Placebo) Powdered Ingredient
Arm Description
Participants will be provided with pre-weighed, foil sachets containing a ready-to-mix flavoured powdered supplement that is rich in milk fat globule membrane (and associated complex milk lipids). They will be asked to consume two sachets daily (mixed with water) during the 4-week study period. Sachets will be coded to maintain study blinding.
Participants will be provided with pre-weighed, foil sachets containing an energy- and macronutrient-matched ready-to-mix powdered placebo supplement that is devoid of milk fat globule membrane (and associated complex milk lipids). They will be asked to consume two sachets daily (mixed with water) during the 4-week study period. Sachets will be coded to maintain study blinding.
Outcomes
Primary Outcome Measures
Change-from-baseline in circulating LDL-cholesterol concentrations
Assessed following the collection of fasted blood samples before and after each 28-day study period
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
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
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
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
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
Change-from-baseline in body mass (kg) using standard equipment.
Assessed in the fasted state before and after each 28-day study period
Change-from-baseline in waist circumference (cm) using standard equipment.
Assessed in the fasted state before and after each 28-day study period
Change-from-baseline in body fat (%) using standard equipment.
Assessed in the fasted state before and after each 28-day study period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05939544
Brief Title
Impact of Milk Fat Globule Membrane Supplementation on Heart and Brain Health
Official Title
Impact of Short-term Supplementation With a Milk Fat Globule Membrane-enriched Powdered Ingredient on Cardiometabolic and Cognitive Health Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
March 10, 2025 (Anticipated)
Study Completion Date
March 10, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loughborough University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Overweight and Obesity, Cognition
Keywords
milk fat globule membrane, milk polar lipids, cholesterol, cardiometabolic risk
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Milk Fat Globule Membrane-enriched Powdered Ingredient
Arm Type
Experimental
Arm Description
Participants will be provided with pre-weighed, foil sachets containing a ready-to-mix flavoured powdered supplement that is rich in milk fat globule membrane (and associated complex milk lipids). They will be asked to consume two sachets daily (mixed with water) during the 4-week study period. Sachets will be coded to maintain study blinding.
Arm Title
Control (Placebo) Powdered Ingredient
Arm Type
Placebo Comparator
Arm Description
Participants will be provided with pre-weighed, foil sachets containing an energy- and macronutrient-matched ready-to-mix powdered placebo supplement that is devoid of milk fat globule membrane (and associated complex milk lipids). They will be asked to consume two sachets daily (mixed with water) during the 4-week study period. Sachets will be coded to maintain study blinding.
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient
Intervention Description
Milk Fat Globule Membrane-enriched Powdered Ingredient
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Comparator: Control (Placebo) Powdered Ingredient
Intervention Description
Placebo Comparator: Control (Placebo) Powdered Ingredient
Primary Outcome Measure Information:
Title
Change-from-baseline in circulating LDL-cholesterol concentrations
Description
Assessed following the collection of fasted blood samples before and after each 28-day study period
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Change-from-baseline in circulating lipid and apolipoprotein concentrations (measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform)
Description
Assessed following the collection of fasted blood samples before and after each 28-day study period
Time Frame
28 days
Title
Change-from-baseline in particle size of lipoprotein subclasses, and concentrations of particles within each subclass by high-throughput 1H-NMR metabolomics platform
Description
Assessed following the collection of fasted blood samples before and after each 28-day study period
Time Frame
28 days
Title
Change-from-baseline in interleukin-6 concentrations (determined by ELISA)
Description
Assessed following the collection of fasted blood samples before and after each 28-day study period
Time Frame
28 days
Title
Change-from-baseline in lipopolysaccharide-binding protein concentrations (determined by ELISA)
Description
Assessed following the collection of fasted blood samples before and after each 28-day study period
Time Frame
28 days
Title
Change-from-baseline in selected gut-related metabolites (for example, trimethylamine N-oxide concentrations determined by mass spectrometry)
Description
Assessed following the collection of fasted blood samples before and after each 28-day study period
Time Frame
28 days
Title
Change-from-baseline in glucose concentrations (determined by spectrophotometric assay)
Description
Assessed following the collection of fasted blood samples before and after each 28-day study period
Time Frame
28 days
Title
Change-from-baseline in insulin concentrations (determined by ELISA)
Description
Assessed following the collection of fasted blood samples before and after each 28-day study period
Time Frame
28 days
Title
Change-from-baseline in HOMA-IR (calculated as [fasting glucose (mmol/L) × fasting insulin (mIU/L)]/22.5])
Description
Assessed following assessment of fasting circulating glucose and insulin concentrations before and after each 28-day study period
Time Frame
28 days
Title
Change-from-baseline in clinic systolic and diastolic blood pressure (assessed by automated upper arm sphygmomanometer)
Description
Assessed in the fasted state before and after each 28-day study period
Time Frame
28 days
Title
Change-from-baseline in arterial stiffness, as assessed by radial pulse wave analysis (using applanation tonometry)
Description
Assessed in the fasted state before and after each 28-day study period
Time Frame
28 days
Title
Change-from-baseline in forearm blood flow, as assessed by venous occlusion plethysmography (using applanation tonometry)
Description
Assessed in the fasted state before and after each 28-day study period
Time Frame
28 days
Title
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
Description
Assessed before and after each 28-day study period
Time Frame
28 days
Title
Change-from-baseline in brain-derived neurotrophic factor concentrations (determined by ELISA)
Description
Assessed in the fasted state before and after each 28-day study period
Time Frame
28 days
Title
Change-from-baseline in body mass (kg) using standard equipment.
Description
Assessed in the fasted state before and after each 28-day study period
Time Frame
28 days
Title
Change-from-baseline in waist circumference (cm) using standard equipment.
Description
Assessed in the fasted state before and after each 28-day study period
Time Frame
28 days
Title
Change-from-baseline in body fat (%) using standard equipment.
Description
Assessed in the fasted state before and after each 28-day study period
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Loughborough University
City
Loughborough
ZIP/Postal Code
LE11 3TU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oonagh Markey, BSc, PhD
Phone
+44 1509 222737
Email
o.markey@lboro.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Milk Fat Globule Membrane Supplementation on Heart and Brain Health
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