Cognitive Performance (Focus)NCT01879813
The Effect of a Phospholipid Drink on Cognitive Performance Under Acute Stress
A study testing Phospholipid drink in people with Cognitive Performance (Focus), run by University of Leeds at 1 site in United Kingdom.
Trial summary
The study will explore the effects of a 6-week phospholipid drink intervention on the cognitive performance and physiological and subjective stress parameters of males following a repeated psychosocial/physical stressor. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Performance (Focus)
- What is being tested?
- Phospholipid drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2012to Aug 2013
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male ≥18 years old
- Healthy (self-report health questionnaire)
- BMI <30 kg/m²
- Free from medication (prescribed and 'over-the-counter')
Who cannot join
- Current psychological affective/mood disorders
- Self-reported physical disorder/disease (significant cardiovascular, autoimmune, endocrine, gastrointestinal or neurological conditions, chronic pain, or sleep disorders)
- High chronic stress
- Smokers
- Recreational drug use (within the last month)
- Night shift work
Show all 11Show fewer
- Hypertension (resting blood pressure exceeding 160/95 mmHg)
- Skin conditions (e.g. eczema) on hands
- Food allergies
- Participation in a clinical study within a month prior to screening or during participation
- Participation in any of our previous stress induction studies
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Appetite Research Unit, University of Leeds
Leeds, West Yorkshire, LS29JT
About this study
Official title: A Randomised, Double-blind, Parallel Groups, Placebo-controlled 6 Weeks Human Intervention Study Investigating the Effect of a Phospholipid Drink on Cognitive Performance
The study will explore the effects of a 6-week phospholipid drink intervention on the cognitive performance and physiological and subjective stress parameters of males following a repeated psychosocial/physical stressor.
Read the detailed description
The study conforms to a randomised, double-blind, placebo controlled, parallel groups design examining cognitive performance and physiological/subjective stress responses after a psychosocial/physical stressor before and after a six week daily intake of an phospholipid containing drink vs. placebo.
The study will examine:
Cognitive performance following acute stress prior to, and following 6-weeks intake of a phospholipid containing drink or a placebo analogue.
Physiological and subjective stress responses following acute stress prior to, and following 6-weeks intake of a phospholipid containing drink or a placebo analogue
- Conditions
- Cognitive Performance (Focus)
- Being tested
- Phospholipid drink, Placebo milk drink
- Keywords
- Memory, Attention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phospholipid drinkDietary supplement
Participant in an intervention parallel group will consume a drink with added phospholipids
Placebo milk drinkDietary supplement
Participant in an intervention parallel group will consume a drink without added phospholipids
| Study group | Role | What they receive |
|---|---|---|
| Phospholipid drink | Active comparator | Participants will consume a phospholipid drink daily for 6 weeks Receives: Dietary Supplement: Phospholipid drink |
| Placebo milk drink | Placebo comparator | Participants will consume a placebo drink (no added phospholipids) daily for 6 weeks Receives: Dietary Supplement: Placebo milk drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance change from baseline
Performance on a cognitive test battery at baseline will be compared to performance at week 6
Measured: Week 1 (baseline) and week 6
Secondary outcomes (5)
Salivary cortisol change from baseline
Salivettes will be used to collect salivary cortisol response across exposure to a laboratory stress protocol on two occasions separated by 6 weeks
Measured: Week 1 (baseline) and week 6
Blood pressure (systolic/diastolic) change from baseline
An ambulatory blood pressure monitor will be used to collect blood pressure response profiles across exposure to a laboratory stress protocol on two occasions separated by 6 weeks
Measured: Week 1 (baseline) and week 6
Heart rate change from baseline
An ambulatory blood pressure monitor will be used to collect heart rate response profiles across exposure to a laboratory stress protocol on two occasions separated by 6 weeks
Measured: Week 1 (baseline) and 6 weeks
Subjective stress change from baseline
The Stress and Arousal Checklist (Mackay, 1978)will be used to collect subjective stress response profiles across exposure to a laboratory stress protocol on two occasions separated by 6 weeks
Measured: Week 1 (baseline) and 6 weeks
Subjective mood change from baseline
The Profile of Mood States (Mc Nair et al., 1971)will be used to collect subjective mood response profiles across exposure to a laboratory stress protocol on two occasions separated by 6 weeks
Measured: Week 1 (baseline) and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Performance (Focus)Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Arla Foods
- Responsible party
- Principal investigator, Prof Louise Dye, University of Leeds
- Investigators
- Louise Dye, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879813
- Sponsor's protocol ID
- Stress and cognition study
- Status last verified
- May 2014
- First submitted
- 15 Oct 2012
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Parallel Groups, Placebo-controlled 6 Weeks Human Intervention Study Investigating the Effect of a Phospholipid Drink on Cognitive Performance
- ClinicalTrials.gov ID
- NCT01879813
- Acronym / sponsor ID
- Stress and cognition study
- Conditions
- Cognitive Performance (Focus)
- Keywords
- Memory, Attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Arla Foods
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 18 Jun 2013 (estimated)
- 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 study will explore the effects of a 6-week phospholipid drink intervention on the cognitive performance and physiological and subjective stress parameters of males following a repeated psychosocial/physical stressor.
Detailed description
The study conforms to a randomised, double-blind, placebo controlled, parallel groups design examining cognitive performance and physiological/subjective stress responses after a psychosocial/physical stressor before and after a six week daily intake of an phospholipid containing drink vs. placebo.
The study will examine:
Cognitive performance following acute stress prior to, and following 6-weeks intake of a phospholipid containing drink or a placebo analogue.
Physiological and subjective stress responses following acute stress prior to, and following 6-weeks intake of a phospholipid containing drink or a placebo analogue
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phospholipid drink | Active comparator | Dietary Supplement: Phospholipid drinkParticipants will consume a phospholipid drink daily for 6 weeks |
| Placebo milk drink | Placebo comparator | Dietary Supplement: Placebo milk drinkParticipants will consume a placebo drink (no added phospholipids) daily for 6 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male ≥18 years old
- Healthy (self-report health questionnaire)
- BMI <30 kg/m²
- Free from medication (prescribed and 'over-the-counter')
Key exclusion criteria (11 listed)
- Current psychological affective/mood disorders
- Self-reported physical disorder/disease (significant cardiovascular, autoimmune, endocrine, gastrointestinal or neurological conditions, chronic pain, or sleep disorders)
- High chronic stress
- Smokers
- Recreational drug use (within the last month)
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 |
|---|---|---|
| Phospholipid drinkParticipant in an intervention parallel group will consume a drink with added phospholipids | Dietary supplement | Phospholipid drink |
| Placebo milk drinkParticipant in an intervention parallel group will consume a drink without added phospholipids | Dietary supplement | Placebo milk drink |
Primary outcome
Cognitive performance change from baseline
Time frame: Week 1 (baseline) and week 6
Performance on a cognitive test battery at baseline will be compared to performance at week 6
5 secondary outcomes
Salivary cortisol change from baseline
Time frame: Week 1 (baseline) and week 6
Blood pressure (systolic/diastolic) change from baseline
Time frame: Week 1 (baseline) and week 6
Heart rate change from baseline
Time frame: Week 1 (baseline) and 6 weeks
Subjective stress change from baseline
Time frame: Week 1 (baseline) and 6 weeks
Subjective mood change from baseline
Time frame: Week 1 (baseline) and 6 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 20 May 2014.
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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.
Louise Dye, PhD principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phospholipid drink in people with Cognitive Performance (Focus), run by University of Leeds 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 4 inclusion and 11 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 20 May 2014. 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?
Cognitive performance change from baseline (time frame: Week 1 (baseline) and week 6). 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 20 May 2014.