Investigating the Effects of Dietary Phospholipids on Stress Reactivity and Recovery

NCT06109922 | Completed

• 1 other identifier: 66CH2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the effects of 6- and 12- week supplementation of a bioactive whey protein concentrate drink containing dairy phospholipids on stress reactivity and recovery in healthy adults. The proposed randomised, double-blind, placebo-controlled parallel groups design methodology will assess the stress reactivity and recovery effects (both self-reported and physiological) of 40g per day of bioactive whey protein concentrate in the form of a powder that the participant will be required to mix with 350ml of water and matched placebo prior to (baseline) and after -6 week and -12 week supplementation. The trial will utilise the Multi-tasking framework (MTF) during testing visits to elicit an acute stress response within the laboratory. Self reported anxiety (STAI short-form) at multiple time points before and after the stressor will be measured as well as perceived task demand following the stressor (NASA-TLX). Physiological measurements of the stress response will also be measured through blood pressure, heart rate arability, and galvanic skin response. 150 participants will participate, aged 25-49, and self-reported as being in good health. Participants will be supplied with either the active treatment or the placebo (allocated by a randomised schedule) whilst visiting the research centre for the testing appointments, and will take treatment home to consume daily for the duration of the study. Participants will record time of taking treatment each day in a treatment diary which will be returned to the research centre, along with any unused treatment, upon completion of the study.

Conditions

Mood; Stress; Physiological Stress

Keywords

mood; stress; stress reactivity; stress recovery; perceived task demand

Outcome Measures

Primary Outcomes (1)

• Stress Reactivity and Recovery

  Ratings of anxiety as defined by the State trait anxiety inventory (STAI) short form sub scale

  Following 6- and 12- week supplementation

Secondary Outcomes (6)

• Perceived Task Demand

  Following the multi-tasking framework at baseline, 6-weeks, and 12- weeks supplementation.

• Galvanic Skin Response- Physiological measure of stress response

  During each completion of the multi-tasking framework (baseline, 6 weeks, and 12 weeks).

• Heart Rate Variability- Physiological measure of stress response

  During each completion of the multi-tasking framework (baseline, 6 weeks, 12 weeks).

• Systolic Blood Pressure- Physiological measure of stress response

  During each completion of the multi-tasking framework (baseline, 6 weeks, and 12 weeks).

• Multi-tasking Framework Overall Scores

  At baseline, 6- weeks, and 12- weeks of intervention.

Study Arms (2)

Experimental

EXPERIMENTAL

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

Dietary Supplement: Active

Placebo

PLACEBO COMPARATOR

Placebo 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 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

Experimental

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:

• Participant must self-assess themselves as being in good health
• Participant must be aged 25 to 49 years at the time of giving consent
• Participants first language is English or are fluent in English

You may not qualify if:

• Have any pre-existing medical conditions/illness which will impact taking part in the study. Cases can be looked at case-by-case.
• 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)
• 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 doctors 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/behavioral 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/ intolerance/ 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 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 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
• 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

Newcastle upon Tyne, United Kingdom

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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: SPONSOR

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

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: January 2, 2024
• Primary Completion: December 20, 2024
• Study Completion: January 20, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)