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

October 14, 2024 updated by: Dr Oonagh Markey, Loughborough University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Loughborough, United Kingdom, LE11 3TU
        • Loughborough University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient
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.
Dietary supplement: Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient
Milk Fat Globule Membrane-enriched Powdered Ingredient
Placebo Comparator: Control (Placebo) Powdered Ingredient
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.
Dietary supplement: Placebo Comparator: Control (Placebo) Powdered Ingredient
Placebo Comparator: Control (Placebo) Powdered Ingredient

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change-from-baseline in circulating LDL-cholesterol concentrations
Time Frame: 28 days
Assessed following the collection of fasted blood samples before and after each 28-day study period
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change-from-baseline in circulating lipid and apolipoprotein concentrations (measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform)
Time Frame: 28 days
Assessed following the collection of fasted blood samples before and after each 28-day study period
28 days
Change-from-baseline in particle size of lipoprotein subclasses, and concentrations of particles within each subclass by high-throughput 1H-NMR metabolomics platform
Time Frame: 28 days
Assessed following the collection of fasted blood samples before and after each 28-day study period
28 days
Change-from-baseline in interleukin-6 concentrations (determined by ELISA)
Time Frame: 28 days
Assessed following the collection of fasted blood samples before and after each 28-day study period
28 days
Change-from-baseline in lipopolysaccharide-binding protein concentrations (determined by ELISA)
Time Frame: 28 days
Assessed following the collection of fasted blood samples before and after each 28-day study period
28 days
Change-from-baseline in selected gut-related metabolites (for example, trimethylamine N-oxide concentrations determined by mass spectrometry)
Time Frame: 28 days
Assessed following the collection of fasted blood samples before and after each 28-day study period
28 days
Change-from-baseline in glucose concentrations (determined by spectrophotometric assay)
Time Frame: 28 days
Assessed following the collection of fasted blood samples before and after each 28-day study period
28 days
Change-from-baseline in insulin concentrations (determined by ELISA)
Time Frame: 28 days
Assessed following the collection of fasted blood samples before and after each 28-day study period
28 days
Change-from-baseline in HOMA-IR (calculated as [fasting glucose (mmol/L) × fasting insulin (mIU/L)]/22.5])
Time Frame: 28 days
Assessed following assessment of fasting circulating glucose and insulin concentrations before and after each 28-day study period
28 days
Change-from-baseline in clinic systolic and diastolic blood pressure (assessed by automated upper arm sphygmomanometer)
Time Frame: 28 days
Assessed in the fasted state before and after each 28-day study period
28 days
Change-from-baseline in arterial stiffness, as assessed by radial pulse wave analysis (using applanation tonometry)
Time Frame: 28 days
Assessed in the fasted state before and after each 28-day study period
28 days
Change-from-baseline in forearm blood flow, as assessed by venous occlusion plethysmography (using applanation tonometry)
Time Frame: 28 days
Assessed in the fasted state before and after each 28-day study period
28 days
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
Time Frame: 28 days
Assessed before and after each 28-day study period
28 days
Change-from-baseline in brain-derived neurotrophic factor concentrations (determined by ELISA)
Time Frame: 28 days
Assessed in the fasted state before and after each 28-day study period
28 days
Change-from-baseline in body mass (kg) using standard equipment.
Time Frame: 28 days
Assessed in the fasted state before and after each 28-day study period
28 days
Change-from-baseline in waist circumference (cm) using standard equipment.
Time Frame: 28 days
Assessed in the fasted state before and after each 28-day study period
28 days
Change-from-baseline in body fat (%) using standard equipment.
Time Frame: 28 days
Assessed in the fasted state before and after each 28-day study period
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Loughborough University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10260

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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