MoodNCT06109922
Investigating the Effects of Dietary Phospholipids on Stress Reactivity and Recovery
A study testing Active in people with Mood and Stress, run by Northumbria University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood, Stress, Physiological Stress
- What is being tested?
- Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jan 2024to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 28Show fewer
- 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
- 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.
- Does not have a bank account (required for payment)
- Are non-compliant with regards treatment consumption
- Follow an "extreme" diet. i.e., high fat, low sugar, low carb, high protein, paleo etc
- Are planning a major lifestyle change regarding diet or exercise regime in the next 3 months.
- Are unable to meet the minimum requirement scores on the cognitive tasks.
- Experienced an event (professional or personal) that is likely to have impacted your emotional and/or psychological state within the last 8-10 weeks (for example but not restricted to change of professional function, death of a family member, divorce, surgery, accident etc)
- Have an upcoming event (personal or professional) that is likely to affect your emotional, psychological state or hormonal state planned during the next 8-10 weeks, including but not limited to job change, house move, important medical exam etc.
- Have a current diagnosis of renal impairments or phenylketonuria
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
Read the detailed description
The study will follow a randomised, placebo-controlled, double-blind, parallel groups design. Participants will be given 12-weeks' worth of either placebo or active treatment to be consumed at home each day (double blinded), will attend all 5 appointments required, will complete the at home treatment diary daily, as well as participate in the multi-tasking stress tasks on each of the 3 testing visits.
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). 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.
The study will include 150 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 350ml of water to form a drink), or a similar of 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 given at testing visit 1.
On each of the three study 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. After completing the cognition tasks outlined in a separate protocol, the participants will be taken one by one to a separate room, accompanied by the lead researcher, to participate in the stress reactivity and recovery task. The task is the Multi-Tasking Framework (MTF) and will last approx. 20 minutes. During this time, participants will be required to remain concentrated on 4 tasks simultaneously to achieve the highest overall score possible. The tasks are a mixture of difficulty and require different skills such as reaction time, memory, and attention. Whilst the participants are completing the tasks, the researcher will be monitoring their performance and providing feedback and instruction. Blood pressure will be taken before and after the task. Questionnaires to measure state anxiety and perceived task demand will be taken at different time points surrounding the stressor. Participants will also be required to wear a heart rate monitor and sensors on their fingertips to measure heart rate variability and galvanic skin response in response to the stressor.
Participants will additionally complete a treatment guess form at their final visit and will be fully debriefed.
- Conditions
- Mood, Stress, Physiological Stress
- Being tested
- Active, Placebo
- Keywords
- mood, stress, stress reactivity, stress recovery, perceived task demand
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveDietary supplement
Also called Active Treatment
40g bio-active whey protein concentrate powder containing phospholipids
PlaceboDietary supplement
Also called Placebo Treatment
Around 40g pea protein powder not containing phospholipids
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress Reactivity and Recovery
Ratings of anxiety as defined by the State trait anxiety inventory (STAI) short form sub scale
Measured: Following 6- and 12- week supplementation
Secondary outcomes (6)
Perceived Task Demand
Treatment effects on perceived task demand of the multi-tasking framework via the NASA task load index (NASA TLX). Five 7- point scales summed to create a measure of perceived mental workload of the multi-tasking framework.
Measured: Following the multi-tasking framework at baseline, 6-weeks, and 12- weeks supplementation.
Galvanic Skin Response- Physiological measure of stress response
treatment effects on physiological stress response via galvanic skin response. Measuring readings of galvanic skin response during each completion of the multi-tasking framework (3) to determine physiological response to the psychological stressor pre, mid and post intervention.
Measured: During each completion of the multi-tasking framework (baseline, 6 weeks, and 12 weeks).
Heart Rate Variability- Physiological measure of stress response
treatment effects on physiological stress response via heart rate variability. Measuring readings of heart rate variability, via a chest strap sensor and polar watch, during each completion of the multi-tasking framework (3) to determine physiological response to the psychological stressor pre, mid, and post intervention.
Measured: During each completion of the multi-tasking framework (baseline, 6 weeks, 12 weeks).
Systolic Blood Pressure- Physiological measure of stress response
Treatment effects on physiological response to stress via systolic blood pressure readings. measuring blood pressure pre and post completion of the multi-tasking framework (3) to determine physiological response to the psychological stressor pre, mid and post intervention.
Measured: During each completion of the multi-tasking framework (baseline, 6 weeks, and 12 weeks).
Multi-tasking Framework Overall Scores
treatment effects on overall multi-tasking framework scores following 6-, and 12- weeks Treatment effects on overall multi-tasking framework scores following 6- and 12- weeks of intervention. Participants receive scores upon completion of 20 minutes of the multi-tasking framework. 10 points per correct answer and 10 points deducted for every incorrect or missed response. Scores can range from minus to positive. Scores indicate engagement in the tasks. The higher the score the higher the engagement in the tasks.
Measured: At baseline, 6- weeks, and 12- weeks of intervention.
Diastolic Blood Pressure- Physiological measure of stress response.
Treatment effects on physiological response to stress via diastolic blood pressure
Measured: During each completion of the Multi-tasking framework (baseline, 6 weeks, and 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start2 Jan 2024
- Primary completion20 Dec 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, double-blind, placebo-controlled, parallel groups design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Volac International Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109922
- Sponsor's protocol ID
- 66CH2
- Status last verified
- Sep 2025
- First submitted
- 25 Oct 2023
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Dietary Phospholipids on Stress Reactivity and Recovery
- ClinicalTrials.gov ID
- NCT06109922
- Acronym / sponsor ID
- 66CH2
- Conditions
- Mood, Stress, Physiological Stress
- Keywords
- mood, stress, stress reactivity, stress recovery, perceived task demand
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Volac International Ltd
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will follow a randomised, placebo-controlled, double-blind, parallel groups design. Participants will be given 12-weeks' worth of either placebo or active treatment to be consumed at home each day (double blinded), will attend all 5 appointments required, will complete the at home treatment diary daily, as well as participate in the multi-tasking stress tasks on each of the 3 testing visits.
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). 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.
The study will include 150 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 350ml of water to form a drink), or a similar of 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 given at testing visit 1.
On each of the three study 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. After completing the cognition tasks outlined in a separate protocol, the participants will be taken one by one to a separate room, accompanied by the lead researcher, to participate in the stress reactivity and recovery task. The task is the Multi-Tasking Framework (MTF) and will last approx. 20 minutes. During this time, participants will be required to remain concentrated on 4 tasks simultaneously to achieve the highest overall score possible. The tasks are a mixture of difficulty and require different skills such as reaction time, memory, and attention. Whilst the participants are completing the tasks, the researcher will be monitoring their performance and providing feedback and instruction. Blood pressure will be taken before and after the task. Questionnaires to measure state anxiety and perceived task demand will be taken at different time points surrounding the stressor. Participants will also be required to wear a heart rate monitor and sensors on their fingertips to measure heart rate variability and galvanic skin response in response to the stressor.
Participants will additionally complete a treatment guess form at their final visit and will be fully debriefed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, double-blind, placebo-controlled, parallel groups design.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: ActiveBioactive 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActiveAlso: Active Treatment40g bio-active whey protein concentrate powder containing phospholipids | Dietary supplement | Experimental |
| PlaceboAlso: Placebo TreatmentAround 40g pea protein powder not containing phospholipids | Dietary supplement | Placebo |
Primary outcome
Stress Reactivity and Recovery
Time frame: Following 6- and 12- week supplementation
Ratings of anxiety as defined by the State trait anxiety inventory (STAI) short form sub scale
6 secondary outcomes
Perceived Task Demand
Time frame: Following the multi-tasking framework at baseline, 6-weeks, and 12- weeks supplementation.
Galvanic Skin Response- Physiological measure of stress response
Time frame: During each completion of the multi-tasking framework (baseline, 6 weeks, and 12 weeks).
Heart Rate Variability- Physiological measure of stress response
Time frame: During each completion of the multi-tasking framework (baseline, 6 weeks, 12 weeks).
Systolic Blood Pressure- Physiological measure of stress response
Time frame: During each completion of the multi-tasking framework (baseline, 6 weeks, and 12 weeks).
Multi-tasking Framework Overall Scores
Time frame: At baseline, 6- weeks, and 12- weeks of intervention.
Diastolic Blood Pressure- Physiological measure of stress response.
Time frame: During each completion of the Multi-tasking framework (baseline, 6 weeks, and 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active in people with Mood and Stress, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress Reactivity and Recovery (time frame: Following 6- and 12- week supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.