Effects of dietary phospholipids on brain health and mood

Investigating the Effects of Dietary Phospholipids on Measures of Human Brain Health and Psychological Wellbeing

This study is testing whether a special drink with dairy ingredients can improve brain function and mood in healthy adults aged 25 to 49.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 25 Years to 49 Years
• Sex: All
• Sponsor: Northumbria University (other)
• Locations: 1 site (Newcastle Upon Tyne)
• Trial ID: NCT06107075 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of a bioactive whey protein concentrate drink containing dairy phospholipids on cognitive function and mood in healthy adults aged 25 to 49. Participants will be randomly assigned to receive either the active supplement or a placebo for 12 weeks, with assessments conducted at baseline, 6 weeks, and 12 weeks. The study employs a double-blind, placebo-controlled design and utilizes the COMPASS cognitive assessment system to measure cognitive performance and various mood metrics throughout the trial. Additionally, participants' dietary habits will be monitored to evaluate any significant changes that may influence the outcomes.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 25 to 49 who self-assess as being in good health and are fluent in English.

Not a fit: Patients with pre-existing medical conditions or those currently taking prescription medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of how dietary phospholipids may improve cognitive function and mood in adults.

How similar studies have performed: While there is ongoing research into dietary impacts on cognitive and mood health, this specific approach using dairy phospholipids is relatively novel and has not been extensively tested.

Eligibility criteria

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 pregnant, seeking to become pregnant or lactating.
* Have been diagnosed with a neurological condition, or assessed as having a learning/behavioural or neurodevelopmental difference (e.g. dyslexia, autism, ADHD.
* Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
* Smoke tobacco or vape nicotine or use nicotine replacement products (if you have recently quit smoking or using replacements you must have stopped using them altogether for a period of 3 months before participating in this study)
* Have excessive caffeine intake (\>500 mg per day). Note: This will be calculated at screening but feel free to query this with the researcher prior to attendance
* Have relevant food allergies/ intolerances/ sensitivities
* Have taken antibiotics within the past 4 weeks.
* Have taken dietary supplements e.g., vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is possible following a 4 week supplement wash out prior to participating and for the duration of the study on the proviso that the supplements they are taking are out of choice and not medically prescribed or advised. Please discuss with the researcher if unsure. NOTE: we would never advise stopping supplements prescribed by your doctor e.g., iron, calcium etc., only those you use out of choice)
* Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
* Are unable to complete all of the study assessments (this will be assessed by the researcher at your training appointment, you must be able to reach minimum scores for each of the cognitive tasks to progress with the trial)
* Are currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks
* Have been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months.
* Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months, including a medical diagnosis of anxiety or depression.
* Suffers from frequent migraines that require medication (more than or equal to 1 per month)
* Have any sleep disorders or take any sleep medications.
* Have any known active infections.
* Have, previously have had, or think you are at risk of having syphilis, hepatitis, the Human T - lymphotropic virus or the Human Immunodeficiency Virus (HIV)
* Have ever had breast cancer and/or a mastectomy.
* Have haemophilia or any similar clotting/blood disorder.
* Have had unprotected sexual intercourse with any person from an HIV high risk population.
* Have ever been involved in intravenous drug use.
* Does not have a bank account (required for payment)
* Are non-compliant with regards treatment consumption
* Follow an "extreme" or very "strict" diet i.e., Keto, very high protein, sugar free, raw paleo etc.
* Are planning a major lifestyle change regarding diet or exercise regime in the next 3 months.
* Have a current diagnosis of renal impairments or phenylketonuria

Where this trial is running

Newcastle Upon Tyne

• Northumbria University - Brain Performance and Nutrition Research Centre — Newcastle Upon Tyne, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Philippa A Jackson, PhD

Conditions: Mood, Cognitive Change, Well-Being, Psychological, Cognition, Well-being, Physical Health