Skip to main content
OpenTrials
Completed

NCT Number: NCT05939544

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Diseases Body Weight Cognition Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loughborough University

Loughborough, LE11 3TU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient

Dietary Supplement

Milk Fat Globule Membrane-enriched Powdered Ingredient

Placebo Comparator: Control (Placebo) Powdered Ingredient

Dietary Supplement

Placebo Comparator: Control (Placebo) Powdered Ingredient

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

Sponsors and collaborators

Lead sponsor

Loughborough University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2023
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.