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

NCT05939544 | Completed

• 1 other identifier: 10260
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Overweight and Obesity; Cognition

Keywords

milk fat globule membrane; milk polar lipids; cholesterol; cardiometabolic risk

Outcome Measures

Primary Outcomes (1)

• Change-from-baseline in circulating LDL-cholesterol concentrations

  Assessed following the collection of fasted blood samples before and after each 28-day study period

  28 days

Secondary Outcomes (16)

• Change-from-baseline in circulating lipid and apolipoprotein concentrations (measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform)

  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

  28 days

• Change-from-baseline in interleukin-6 concentrations (determined by ELISA)

  28 days

• Change-from-baseline in lipopolysaccharide-binding protein concentrations (determined by ELISA)

  28 days

• Change-from-baseline in selected gut-related metabolites (for example, trimethylamine N-oxide concentrations determined by mass spectrometry)

  28 days

Study Arms (2)

Milk Fat Globule Membrane-enriched Powdered Ingredient

EXPERIMENTAL

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

Control (Placebo) Powdered Ingredient

PLACEBO COMPARATOR

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

Interventions

Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient DIETARY_SUPPLEMENT

Milk Fat Globule Membrane-enriched Powdered Ingredient

Milk Fat Globule Membrane-enriched Powdered Ingredient

Placebo Comparator: Control (Placebo) Powdered Ingredient DIETARY_SUPPLEMENT

Placebo Comparator: Control (Placebo) Powdered Ingredient

Control (Placebo) Powdered Ingredient

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loughborough University: lead

Study Sites (1)

Loughborough University

Loughborough, LE11 3TU, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 11, 2023
• Study Start: July 10, 2023
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)