Healthy But Chronically StressedPhase 2MemLearnNCT02257801

Effects of Lutein on Learning and Memory in Chronically Stressed Subjects and in an Acute Stressful Situation (TSST - Trier Social Stress Test): A Randomized, Double-blind, Placebo-controlled Trial)

A Phase 2 study testing Nutritional beverage fortified with 6mg lutein/day and Nutritional beverage fortified with 12mg lutein/day in people with Healthy But Chronically Stressed, run by dsm-firmenich Switzerland AG at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to study effects of a four months lutein supplementation (in form of a lutein fortified nutritional beverage) on general learning and memory performance as well as on acute stress-induced changes in learning and memory performance in chronically stressed males and females using 2 different… Read more about this study

Who is it for?: Ages 50 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy But Chronically Stressed
What is being tested?: Nutritional beverage fortified with 6mg lutein/day and Nutritional beverage fortified with 12mg lutein/day
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 1 siteGermany
Study dates: Jan 2013to Dec 2014
Phase: Phase 2
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 50 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Males and females aged 50 - 70 yrs
Subjects perceiving themselves as chronically stressed and as verified by the TICS questionnaire with scores > 18 and < 48.
Subject is willing to maintain his or her habitual diet and physical activity patterns throughout the study period
Subject has a body mass index (BMI) of ≥ 18.50 and ≤ 32.00 kg/m2 at screening.
Subject is willing to abstain from consuming alcoholic drinks 24 h and from consuming caffeine and caffeine containing products 12 h prior to test days until the end of each visit
Subject is willing to refrain from heavy physical activity 12 h prior to test days
Subject finds the taste of the nutritional drink acceptable and is willing to consume 2 drinks per day for the whole study duration
Subject understands the study procedures and signs the informed consent to participate in the study

Who cannot join

Subject has a positive drug screening of amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, methamphetamines, methadone, opiates, phencyclidine or tricyclic antidepressants at screening or at any of the admission days
Subject has a positive breath alcohol (as a test for alcohol consumption) or breath carbon monoxide (as test for smoking habits and to exclude smokers) at screening or at any of the admission days
Subject has any health conditions that would prevent from fulfilling the study requirements, put the subject at risk or would confound the interpretation of the study results as judged by the Investigator on the basis of medical history and routine laboratory test results
Subjects with a history of renal or hepatic disease that is likely to interfere with the metabolism or excretion of the test product
Subject has donated more than 300 mL of blood during the last three months prior to screening
Subject has uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mm Hg) at screening

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Subject has a history of psychological illness or condition that interferes with the subject's ability to understand the requirements of the study
Subject has Diabetes Mellitus
Subject has a history/ presence of cancer during the last two years (excluding non-melanoma skin cancer)
Excessive caffeine consumption (>400 mg caffeine/d or ≥4 cups of caffeinated coffee/d), following screening and throughout the study period
Use of antibiotics or signs of active systemic infections. Treatment visits might be rescheduled
Subject is on any medication (with the exception of contraception and short-term use of pain treatment e.g. against headache (i.e. 1-2 day use of analgetics such as Paracetamol or ASS) as well as persistent (for at least three months) and well-adjusted medication (e.g. thyroid and blood pressure medication) with no influence on study outcome as judged by the investigator)
Subject is currently on a regular oral nutrition solution such as Ensure®, Boost® or similar products. Regular is defined as one or more bottles/ cans per day average consumption over the last 10 or more days
Subjects who are on a significant hypocaloric diet aiming for significant weight loss
Use of dietary supplements containing any of the following: lutein, ginkgo biloba, St. John's wort, ginseng, gotu kola (Indian pennywort); daily doses of vitamin E (≥30 mg/d) or folic acid (≥400 μg/d); thiamine, riboflavin, and/or pyridoxine (≥2 mg/d); and eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) or a combination of EPA + DHA (≥500 mg/d) within 2 weeks prior to screening
Subject is a vegetarian
Subject has had exposure to any non-registered drug product within 30 days prior to the screening visit
Recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as > 60g (men)/ 40g (women) pure alcohol per day (1.5 l / 1 l beer resp. 0.75 l / 0.5 l wine)
Subject has a known allergy or sensitivity to the study product or any ingredients of the study product or meals provided, especially against soy and milk protein
Subject is pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation
Subject is unable to perform the tests on the CANTAB system during training as being flagged by the software

Trial locations and contacts

1 site in 1 country.

Germany1 site

DAaCRO GmbH
Trier, Trier, D-54296

Other trials in Germany

About this study

Official title: Effects of Lutein on Learning and Memory in Chronically Stressed Subjects and in an Acute Stressful Situation (TSST - Trier Social Stress Test): A Randomized, Double-blind, Placebo-controlled Trial

Conditions: Healthy But Chronically Stressed
Being tested: Nutritional beverage fortified with 6mg lutein/day, Nutritional beverage fortified with 12mg lutein/day
Keywords: Memory, Cognition, Execute Function, Attention, Mood

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nutritional beverage fortified with 6mg lutein/dayDietary supplement
2 beverages (each containing 3mg lutein) per day (total of 6mg lutein/day) for a total of 4 months
Nutritional beverage fortified with 12mg lutein/dayDietary supplement
2 beverages (each containing 6mg lutein) per day (total 12mg lutein/day) for a total of 4 months
Nutritional beverage fortified with 12mg lutein/dayDietary supplement
2 beverages (each containing 0mg lutein) per day (total 0mg lutein/day) for a total of 4 months

Study groups in NCT02257801
Study group	Role	What they receive
Nutritional beverage fortified with 6mg lutein/day	Experimental	Not described Receives: Dietary Supplement: Nutritional beverage fortified with 6mg lutein/day
Nutritional beverage fortified with 12mg lutein/day	Experimental	Not described Receives: Dietary Supplement: Nutritional beverage fortified with 12mg lutein/day
Nutritional beverage fortified with 0mg lutein/day	Placebo comparator	Not described Receives: Dietary Supplement: Nutritional beverage fortified with 12mg lutein/day

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Memory (Paired Associates Learning (PAL / CANTAB))
Visual Memory Task on a computer. Outcome measurements: Change of accuracy (total error adjusted) from baseline measurement to 2 months
Measured: Day 0 (baseline) - day 57
Visual Memory (Paired Associates Learning (PAL / CANTAB))
Visual Memory Task on a computer. Outcome measurements: Change of accuracy (total error adjusted) from baseline measurement to 4 months
Measured: Day 0 (baseline) - day 113
Visual Memory (Verbal Recognition Memory (VRM /CANTAB))
Visual Memory Task on a computer. Outcome measurements: Change of accuracy (total number of words correct on immediate recall (the sum of the two free recall trials immediately after each presentation) and delayed recall (the number of correctly recalled words after a delay of approximately 30 min)) from baseline measurement to 2 months
Measured: Day 0 (baseline) - day 57
Visual Memory (Verbal Recognition Memory (VRM /CANTAB))
Visual Memory Task on a computer. Outcome measurements: Change of accuracy (total number of words correct on immediate recall (the sum of the two free recall trials immediately after each presentation) and delayed recall (the number of correctly recalled words after a delay of approximately 30 min)) from baseline measurement to 4 months
Measured: Day 0 (baseline) - day 113
Executive Function (Spatial Working Memory (SWM / CANTAB))
Executive Memory Task on a computer. Outcome measurements: Change of accuracy (the total number of between search errors at 4-, 6- and 8-box stages and the strategy score) from baseline measurement to 2 months
Measured: Day 0 (baseline) - day 57
Executive Function (Spatial Working Memory (SWM / CANTAB))
Executive Memory Task on a computer. Outcome measurements: Change of accuracy (the total number of between search errors at 4-, 6- and 8-box stages and the strategy score) from baseline measurement to 4 months
Measured: Day 0 (baseline) - day 113
Executive Function (Spatial Span (SSP / CANTAB))
Executive Memory Task on a computer. Outcome measurements: Change of accuracy (Span length forwards) from baseline measurement to 2 months
Measured: Day 0 (baseline) - day 57
Executive Function (Spatial Span (SSP / CANTAB))
Executive Memory Task on a computer. Outcome measurements: Change of accuracy (Span length forwards) from baseline measurement to 4 months
Measured: Day 0 (baseline) - day 113
Attention and Concentration (Reaction Time (RTI / CANTAB))
Attention and Concentration Task on a computer. Outcome measurements: Change of reaction time from baseline measurement to 2 months
Measured: Day 0 (baseline) - day 57
Attention and Concentration (Reaction Time (RTI / CANTAB))
Attention and Concentration Task on a computer. Outcome measurements: Change of reaction time from baseline measurement to 4 months
Measured: Day 0 (baseline) - day 113
Attention and Concentration (Rapid Visual Information Processing (RVP / CANTAB))
Attention and Concentration Task on a computer. Outcome measurements: Change of target sensitivity and response latency from baseline measurement to 2 months
Measured: Day 0 (baseline) - day 57
Attention and Concentration (Rapid Visual Information Processing (RVP / CANTAB))
Attention and Concentration Task on a computer. Outcome measurements: Change of target sensitivity and response latency from baseline measurement to 4 months
Measured: Day 0 (baseline) - day 113
Verbal Fluency: Regensburg Verbal Fluency Test (RWT)
Verbal Fluency Task on a computer. Outcome measurements: Change of accuracy (amount of correct answers, breaches of rules, repetitions and total errors) from baseline measurement to 2 months
Measured: Day 0 (baseline) - day 57
Verbal Fluency: Regensburg Verbal Fluency Test (RWT)
Verbal Fluency Task on a computer. Outcome measurements: Change of accuracy (amount of correct answers, breaches of rules, repetitions and total errors) from baseline measurement to 4 months
Measured: Day 0 (baseline) - day 113

Secondary outcomes (10)

Visual Memory after TSST (Paired Associates Learning (PAL / CANTAB))
Visual Memory PAL will be tested before and after an acute social stress test (Trier Social Stress Test (TSST)). Outcome measure: Difference in accuracy (total error adjusted) from before to after TSST.
Measured: Day 113
Visual Memory after TSST (Verbal Recognition Memory (VRM /CANTAB))
Visual Memory VRM will be tested before and after an acute social stress test (Trier Social Stress Test (TSST)). Outcome measure: Difference in accuracy from before to after TSST.
Measured: Day 113
Executive Function after TSST (Spatial Working Memory (SWM / CANTAB))
Executive Function SWM will be tested before and after an acute social stress test (Trier Social Stress Test (TSST)). Outcome measure: Difference in accuracy from before to after TSST.
Measured: Day 113
Executive Function after TSST (Spatial Span (SSP / CANTAB))
Executive Function SSP will be tested before and after an acute social stress test (Trier Social Stress Test (TSST)). Outcome measure: Difference in accuracy from before to after TSST.
Measured: Day 113
Mood (Visual Analog Scale (VAS))
Mood will be assessed by VAS. Outcome variables on: alertness, calmness and contentment. Changes of these parameters from baseline day to day 57 and from before to after cognitive test batteries on test days as described above.
Measured: Day 0 (baseline) to day 57
Mood (Visual Analog Scale (VAS))
Mood will be assessed by VAS. Outcome variables on: alertness, calmness and contentment. Changes of these parameters from baseline day to day 113 and from before to after cognitive test batteries on test days as described above.
Measured: Day 0 (baseline) to day 113
Stress (Perceived Stress Scale (PSS))
Changes on stress levels will be assessed by PSS. Outcome variables: changes of how unpredictable, uncontrollable, and overloaded subjects perceive their lives.
Measured: Day 0 (baseline) to day 57
Stress (Perceived Stress Scale (PSS))
Changes on stress levels will be assessed by PSS. Outcome variables: changes of how unpredictable, uncontrollable, and overloaded subjects perceive their lives.
Measured: Day 0 (baseline) to day 113
Anxiety (State-Trait-Anxiety Inventory (STAI))
Changes on personal sensed anxiety levels will be assessed by the STAI questionnaire. Outcome variables: changes of state or trait anxiety scale from before TSST to after the TSST on day 113.
Measured: Day 113
Erythrocyte and serum lutein levels
Changes in erythrocyte and serum lutein levels will be assessed between baseline and day 113.
Measured: Day 0 (baseline) to day 113

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Dec 2014

First posted6 Oct 2014 (estimated)
Study startJan 2013
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy But Chronically StressedStudies 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 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02257801
Sponsor's protocol ID: 2011-11-02-LUTE / D1-2011
Acronym: MemLearn
Status last verified: Jan 2016
First submitted: 2 Oct 2014
Last updated: 22 Jan 2016
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Lutein on Learning and Memory in Chronically Stressed Subjects and in an Acute Stressful Situation (TSST - Trier Social Stress Test): A Randomized, Double-blind, Placebo-controlled Trial
ClinicalTrials.gov ID: NCT02257801
Acronym / sponsor ID: MemLearn / 2011-11-02-LUTE / D1-2011
Conditions: Healthy But Chronically Stressed
Keywords: Memory, Cognition, Execute Function, Attention, Mood
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
Collaborators: Abbott Nutrition
Study start: Jan 2013
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 6 Oct 2014 (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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Nutritional beverage fortified with 6mg lutein/day	Experimental	Dietary Supplement: Nutritional beverage fortified with 6mg lutein/day
Nutritional beverage fortified with 12mg lutein/day	Experimental	Dietary Supplement: Nutritional beverage fortified with 12mg lutein/day
Nutritional beverage fortified with 0mg lutein/day	Placebo comparator	Dietary Supplement: Nutritional beverage fortified with 12mg lutein/day

Who may qualify

Ages: 50 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Males and females aged 50 - 70 yrs
Subjects perceiving themselves as chronically stressed and as verified by the TICS questionnaire with scores > 18 and < 48.
Subject is willing to maintain his or her habitual diet and physical activity patterns throughout the study period
Subject has a body mass index (BMI) of ≥ 18.50 and ≤ 32.00 kg/m2 at screening.
Subject is willing to abstain from consuming alcoholic drinks 24 h and from consuming caffeine and caffeine containing products 12 h prior to test days until the end of each visit

Key exclusion criteria (21 listed)

Subject has a positive drug screening of amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, methamphetamines, methadone, opiates, phencyclidine or tricyclic antidepressants at screening or at any of the admission days
Subject has a positive breath alcohol (as a test for alcohol consumption) or breath carbon monoxide (as test for smoking habits and to exclude smokers) at screening or at any of the admission days
Subject has any health conditions that would prevent from fulfilling the study requirements, put the subject at risk or would confound the interpretation of the study results as judged by the Investigator on the basis of medical history and routine laboratory test results
Subjects with a history of renal or hepatic disease that is likely to interfere with the metabolism or excretion of the test product
Subject has donated more than 300 mL of blood during the last three months prior to screening

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
Nutritional beverage fortified with 6mg lutein/day2 beverages (each containing 3mg lutein) per day (total of 6mg lutein/day) for a total of 4 months	Dietary supplement	Nutritional beverage fortified with 6mg lutein/day
Nutritional beverage fortified with 12mg lutein/day2 beverages (each containing 6mg lutein) per day (total 12mg lutein/day) for a total of 4 months	Dietary supplement	Nutritional beverage fortified with 12mg lutein/day
Nutritional beverage fortified with 12mg lutein/day2 beverages (each containing 0mg lutein) per day (total 0mg lutein/day) for a total of 4 months	Dietary supplement	Nutritional beverage fortified with 0mg lutein/day

Primary outcome

Visual Memory (Paired Associates Learning (PAL / CANTAB))
Time frame: Day 0 (baseline) - day 57
Visual Memory Task on a computer. Outcome measurements: Change of accuracy (total error adjusted) from baseline measurement to 2 months
Visual Memory (Paired Associates Learning (PAL / CANTAB))
Time frame: Day 0 (baseline) - day 113
Visual Memory Task on a computer. Outcome measurements: Change of accuracy (total error adjusted) from baseline measurement to 4 months
Visual Memory (Verbal Recognition Memory (VRM /CANTAB))
Time frame: Day 0 (baseline) - day 57
Visual Memory Task on a computer. Outcome measurements: Change of accuracy (total number of words correct on immediate recall (the sum of the two free recall trials immediately after each presentation) and delayed recall (the number of correctly recalled words after a delay of approximately 30 min)) from baseline measurement to 2 months
Visual Memory (Verbal Recognition Memory (VRM /CANTAB))
Time frame: Day 0 (baseline) - day 113
Visual Memory Task on a computer. Outcome measurements: Change of accuracy (total number of words correct on immediate recall (the sum of the two free recall trials immediately after each presentation) and delayed recall (the number of correctly recalled words after a delay of approximately 30 min)) from baseline measurement to 4 months
Executive Function (Spatial Working Memory (SWM / CANTAB))
Time frame: Day 0 (baseline) - day 57
Executive Memory Task on a computer. Outcome measurements: Change of accuracy (the total number of between search errors at 4-, 6- and 8-box stages and the strategy score) from baseline measurement to 2 months
Executive Function (Spatial Working Memory (SWM / CANTAB))
Time frame: Day 0 (baseline) - day 113
Executive Memory Task on a computer. Outcome measurements: Change of accuracy (the total number of between search errors at 4-, 6- and 8-box stages and the strategy score) from baseline measurement to 4 months
Executive Function (Spatial Span (SSP / CANTAB))
Time frame: Day 0 (baseline) - day 57
Executive Memory Task on a computer. Outcome measurements: Change of accuracy (Span length forwards) from baseline measurement to 2 months
Executive Function (Spatial Span (SSP / CANTAB))
Time frame: Day 0 (baseline) - day 113
Executive Memory Task on a computer. Outcome measurements: Change of accuracy (Span length forwards) from baseline measurement to 4 months
Attention and Concentration (Reaction Time (RTI / CANTAB))
Time frame: Day 0 (baseline) - day 57
Attention and Concentration Task on a computer. Outcome measurements: Change of reaction time from baseline measurement to 2 months
Attention and Concentration (Reaction Time (RTI / CANTAB))
Time frame: Day 0 (baseline) - day 113
Attention and Concentration Task on a computer. Outcome measurements: Change of reaction time from baseline measurement to 4 months
Attention and Concentration (Rapid Visual Information Processing (RVP / CANTAB))
Time frame: Day 0 (baseline) - day 57
Attention and Concentration Task on a computer. Outcome measurements: Change of target sensitivity and response latency from baseline measurement to 2 months
Attention and Concentration (Rapid Visual Information Processing (RVP / CANTAB))
Time frame: Day 0 (baseline) - day 113
Attention and Concentration Task on a computer. Outcome measurements: Change of target sensitivity and response latency from baseline measurement to 4 months
Verbal Fluency: Regensburg Verbal Fluency Test (RWT)
Time frame: Day 0 (baseline) - day 57
Verbal Fluency Task on a computer. Outcome measurements: Change of accuracy (amount of correct answers, breaches of rules, repetitions and total errors) from baseline measurement to 2 months
Verbal Fluency: Regensburg Verbal Fluency Test (RWT)
Time frame: Day 0 (baseline) - day 113
Verbal Fluency Task on a computer. Outcome measurements: Change of accuracy (amount of correct answers, breaches of rules, repetitions and total errors) from baseline measurement to 4 months

10 secondary outcomes

Visual Memory after TSST (Paired Associates Learning (PAL / CANTAB))
Time frame: Day 113
Visual Memory after TSST (Verbal Recognition Memory (VRM /CANTAB))
Time frame: Day 113
Executive Function after TSST (Spatial Working Memory (SWM / CANTAB))
Time frame: Day 113
Executive Function after TSST (Spatial Span (SSP / CANTAB))
Time frame: Day 113
Mood (Visual Analog Scale (VAS))
Time frame: Day 0 (baseline) to day 57
Mood (Visual Analog Scale (VAS))
Time frame: Day 0 (baseline) to day 113
Stress (Perceived Stress Scale (PSS))
Time frame: Day 0 (baseline) to day 57
Stress (Perceived Stress Scale (PSS))
Time frame: Day 0 (baseline) to day 113
Anxiety (State-Trait-Anxiety Inventory (STAI))
Time frame: Day 113
Erythrocyte and serum lutein levels
Time frame: Day 0 (baseline) to day 113

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 22 Jan 2016.

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.

Michael Clemens, MD principal investigator

DAaCRO GmbH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 21 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 22 Jan 2016. 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 Germany. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Visual Memory (Paired Associates Learning (PAL / CANTAB)) (time frame: Day 0 (baseline) - day 57). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02257801.

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 22 Jan 2016.