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

Loughborough University

Status: Completed

Conditions: Overweight and Obesity; Cardiovascular Diseases; Cognition

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05939544

10260

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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18 participants in 2 patient groups, including a placebo group

Milk Fat Globule Membrane-enriched Powdered Ingredient

Experimental group

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.

Treatment:

Dietary Supplement: Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient

Control (Placebo) Powdered Ingredient

Placebo Comparator group

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.

Treatment:

Dietary Supplement: Placebo Comparator: Control (Placebo) Powdered Ingredient