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

NCT06107075 | Recruiting

• 1 other identifier: 66CH1
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mood; Cognitive Change; Well-Being, Psychological

Keywords

Cognition; Mood; Well-being; Physical Health

Outcome Measures

Primary Outcomes (1)

• Cognitive function - Cognitive domain factor score

  Effects of supplementation on the cognitive domain memory, measured using the following tasks through the Computerised Mental Performance Assessment System (COMPASS, Northumbria University) :Numeric Working Memory, immediate word recall, delayed word recall, delayed word recognition, and delayed picture recognition. Participants will receive scores of accuracies on all tasks, which will be in the form of the percentage of responses correct. Higher scores indicate better memory performance, lower scores indicate worse memory performance.

  prior to (baseline) and following chronic dose of intervention at 6 weeks and 12 weeks.

Secondary Outcomes (12)

• Profile of Mood States (POMS)

  prior to (baseline) and following 6- and 12-week chronic intervention

• Perceived Stress Scale (PSS)

  prior to (baseline) and following 6- and 12-week chronic intervention

• Perceived Stress Reactivity Scale (PSRS)

  prior to (baseline) and following 6- and 12- week chronic intervention

• The Cohen-Hoberman Inventory of Physical Symptoms (CHIPS)

  Prior to (baseline) and following 6- and 12- week chronic intervention

• Subjective sleep via the Patient-Reported Outcome Measurement, Information System Sleep Disturbance Scale- shoer form (PROMIS-SD)

  prior to (baseline) and following 6- and 12-week chronic intervention

Study Arms (2)

Bioactive whey protein concentrate containing phospholipids

EXPERIMENTAL

Bioactive whey protein concentrate containing phospholipids 40g powder mixed with 350ml water consumed once daily for 12 weeks alongside their fattiest meal of the day.

Dietary Supplement: Active

Placebo

PLACEBO COMPARATOR

Placebo powder matched for macronutrient and caloric content containing pea protein around 40g powder mixed with 350ml water consumed once daily for 12 weeks alongside their fattiest meal of the day.

Dietary Supplement: Placebo

Interventions

Active DIETARY_SUPPLEMENT

40g bio-active whey protein concentrate powder containing phospholipids

Also known as: active treatment

Bioactive whey protein concentrate containing phospholipids

Placebo DIETARY_SUPPLEMENT

around 40g pea protein powder not containing phospholipids

Also known as: Placebo Treatment

Placebo

Eligibility Criteria

• Age: 25 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead
• Volac International Ltd: collaborator

Study Sites (1)

Northumbria University - Brain Performance and Nutrition Research Centre

Newcastle upon Tyne, United Kingdom

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Exercise

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Philippa A Jackson, PhD

CONTACT

01912274468; philippa.jackson@northumbria.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Investigator, Outcomes Assessor)- Treatment will be blinded according to the randomisation schedule by a researcher who has no other involvement in the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised, placebo-controlled, double-blind, parallel groups design

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: January 2, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)