NCT05939544Completed
Impact of Milk Fat Globule Membrane Supplementation on Heart and Brain Health
Impact of Short-term Supplementation with a Milk Fat Globule Membrane-enriched Powdered Ingredient on Cardiometabolic and Cognitive Health Outcomes
Source: ClinicalTrials.gov · Last updated 16 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 23 Jun 2023
- Start date
- 10 Jul 2023
- Primary completion date
- 24 Sept 2024
- Lead sponsor
- Loughborough University
- Diseases
- Obesity
- NCT number
- NCT05939544
What you commit to
- Study type: Interventional
- Participants enrolled: 18
- From 10 Jul 2023 to the primary completion date, 24 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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.
Other illness
- 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.
- Known allergy or intolerance to study food (lactose intolerance, dairy)
Other
- Smoking (including vaping)
- 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
Who the study is looking for
- 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
Age in the registry: 40 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Loughborough University Coordinator of this site? Confirm its status | Loughborough | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.