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

Cognitive Change Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The study will follow a randomised, placebo-controlled, double-blind, parallel groups design.

Participants will attend the research centre on four separate occasions, which will include a screening/training visit, pre intervention testing visit, a mid-point testing visit (at 6 weeks), and a completion of intervention testing visit (at 12 weeks). There will be 5 appointments in total including the online appointment to check for eligibility. The remote screening session will be completed via telephone call and will comprise briefing on the requirements for the study, answering any initial questions, obtaining of informed consent via completion of an online consent form, health screening, collection of demographic information, and completion of the Caffeine Consumption Questionnaire (CCQ).

The introductory/training visit to the laboratory will begin with physiological eligibility measures that cannot be completed remotely (e.g., blood pressure, height and weight, waist-to-hip ratio) followed by training on the cognitive and mood measures.

Opportunity sampling will be used to recruit participants. The study will include 220 healthy participants aged between 25-49 years, who will receive 12 weeks' worth of either 40g per day of bioactive whey protein concentrate powder containing dairy phospholipids (to be mixed with approx. 350ml water to form a drink), or similar amount per day of matched placebo powder. Participants will be randomly allocated to either the treatment or placebo group and neither the participant nor the researcher will know which group they have been allocated to. Full instructions of how and when to take treatment each day will be explained to the participants when treatment is provided at testing visit 1.

The day before each of the study testing days, participants will be sent a link to a set of questionnaires they must complete before attending the lab on the following day. The set includes questionnaires measuring perceived stress, sleep quality, levels of fatigue, physical symptoms, and general health and well-being. The questionnaires should take the participants approx. 45 minutes to complete on their computer, smartphone, or tablet at home.

On each of the three study testing days (Day 1, 42, and 84) participants will attend the research centre, having abstained from alcohol for 24 hours, and caffeine overnight, following a standardised breakfast of cereal and/or toast at home no later than 1 hour prior to arrival. Upon arrival to the research centre, participants continued eligibility will be checked before completing the 1 hour long computerised cognitive assessment using the Computerised mental performance assessment system (COMPASS). The cognitive assessment will employ a broad selection of tasks assessing performance within the "Attention", "Working Memory", "Episodic Memory", "learning" and "Executive Function" cognitive domains. The cognitive demand battery (CDB), which assess cognitive functioning and subjective mental fatigue during sustained performance of mentally demanding tasks, will also be incorporated. Upon completion of the computerised cognitive assessment, participants will complete the NASA task load index (NASA TLX) to measure perceived task mental demand.

Participants will additionally complete a treatment guess form at their final visit and will be fully debriefed.

Participants that opt into the blood sampling portion of this study will also attend the research centre on two separate additional occasions, the day (or two days) before the first and final testing visit, to have their blood taken. Participants will be required to attend the research centre fasted and therefore all blood draw appointments will be held in the morning. A venous blood sample will be taken by a trained phlebotomist. Samples will then be processed and stored at Northumbria University until time of analysis where they will be analysed for plasma phospholipid profiles. These additional blood visit will last approx. 15 minutes per visit. ;

Related Conditions & MeSH terms

• Cognitive Change
• Mood

• NCT number: NCT06107075
• Study type: Interventional
• Source: Northumbria University
• Contact: Philippa A Jackson, PhD
• Phone: 01912274468
• Email: philippa.jackson@northumbria.ac.uk
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2024
• Completion date: May 1, 2025