Investigating the Effects of Dietary Phospholipids on Measures of Human Brain Health and Psycholo… (NCT06107075) | Clinical Trial Compass
CompletedNot Applicable
Investigating the Effects of Dietary Phospholipids on Measures of Human Brain Health and Psychological Wellbeing
United Kingdom119 participantsStarted 2024-01-02
Plain-language summary
The aim of this study is to investigate the effects of 6- and 12-week supplementation of a bioactive whey protein concentrate drink containing dairy phospholipids on cognitive function and mood in healthy young to middle aged adults.
The proposed randomised, double blind, placebo-controlled, parallel groups design methodology will assess the cognitive, mood and lifestyle effects of 40g per day of bioactive whey protein concentrate powder mixed with water and matched placebo prior to (baseline) and after -6 and 12-week supplementation. The trial will utilise the COMPASS cognitive assessment system (Northumbria University) during the laboratory visits to measure performance on the cognitive tasks and a range of mood measures between visits examining general mood, stress, depression, anxiety, sleep quality, fatigue, and physical symptoms.
Additionally, dairy dietary habits will be recorded throughout to allow for any significant changes to diet to be assessed for the potential influence on the outcome variables.
Participants will be asked not to make any major changes to their diet or exercise regime for the duration of the trial. This will be checked by asking the participant if there has been any significant changes at each visit.
Blood samples will also be taken from a subset of participants who opt into this part of the trial to measure any changes to plasma phospholipid profiles.
220 participants will participate, aged 25-49, and self-report as in good health. Participants will be supplied with the treatment whilst visiting the research centre on testing days and will then consume treatment at home daily. Participants will record the time they take their treatment each day in a diary that will then be returned to the research team at the end of the study testing period.
Who can participate
Age range
25 Years – 49 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must self-assess themselves as being in good health.
* Participants must be aged 25 to 49 years at the time of giving consent.
* Participant must be fluent in English and/or English is their first language
Exclusion Criteria:
* Have any pre-existing medical conditions/illness which will impact taking part in the study. There may be other, unforeseen exceptions and these will be considered on a case-by-case basis: i.e., participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance. It is therefore worth discussing any medical conditions with the researcher prior to booking lab appointments
* Are currently taking any prescription medications (NOTE the explicit exceptions to this are contraceptive treatments for female participants, and those taking "as needed" in the treatment of asthma and/or hay fever. There may be other instances of medication use which, where no interaction with the active treatment is likely, and which would not be expected to have any impact on brain function, participants may be able to progress to screening
* Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg). NOTE: that we must measure this in the lab using our blood pressure monitors and can only use our measurements to assess eligibility rather than home or GP readings
* Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2.
* Are…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cognitive function - Cognitive domain factor score
Timeframe: prior to (baseline) and following chronic dose of intervention at 6 weeks and 12 weeks.