Impact of Milk Fat Globule Membrane Supplementation on Heart and Brain Health
NCT ID: NCT05939544
Last Updated: 2024-10-16
Study Results
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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COMPLETED
NA
18 participants
INTERVENTIONAL
2023-07-10
2024-09-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
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.
Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient
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.
Placebo Comparator: Control (Placebo) Powdered Ingredient
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
Placebo Comparator: Control (Placebo) Powdered Ingredient
Placebo Comparator: Control (Placebo) Powdered Ingredient
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
70 Years
ALL
Yes
Sponsors
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Loughborough University
OTHER
Responsible Party
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Dr Oonagh Markey
Principal Investigator
Locations
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Loughborough University
Loughborough, , United Kingdom
Countries
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Other Identifiers
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10260
Identifier Type: -
Identifier Source: org_study_id
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