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

NCT ID: NCT05939544

Last Updated: 2024-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2024-09-24

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Diseases Overweight and Obesity Cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient

Intervention Type DIETARY_SUPPLEMENT

Milk Fat Globule Membrane-enriched Powdered Ingredient

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.

Group Type PLACEBO_COMPARATOR

Placebo Comparator: Control (Placebo) Powdered Ingredient

Intervention Type DIETARY_SUPPLEMENT

Placebo Comparator: Control (Placebo) Powdered Ingredient

Interventions

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Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient

Milk Fat Globule Membrane-enriched Powdered Ingredient

Intervention Type DIETARY_SUPPLEMENT

Placebo Comparator: Control (Placebo) Powdered Ingredient

Placebo Comparator: Control (Placebo) Powdered Ingredient

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Loughborough University

OTHER

Sponsor Role lead

Responsible Party

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Dr Oonagh Markey

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Loughborough University

Loughborough, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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10260

Identifier Type: -

Identifier Source: org_study_id

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