AzTrials
AzTrials

HealthyPhase 2P2B_UKNCT02172859

Dietary Influence on Serotonin in Cognitive and Emotional Functioning in Women

A Phase 2 study testing lumiVida™ in people with Healthy, run by dsm-firmenich Switzerland AG at 1 site in United Kingdom.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether a chronic dose of a tryptophan-rich protein drink (lumiVida™) can improve cognitive function, emotional processing and sleep in middle-aged women. In addition, also genetic predictors of susceptibility to an increase of Trp levels will be investigated. Read more about this study

Who is it for?
Ages 45 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
lumiVida™
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
59 participants
Where
1 siteUnited Kingdom
Study dates
Nov 2010to Jul 2011
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 45 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Physically and mentally healthy (defined by not concurrently receiving medical/pharmacological treatment (except mild painkillers), free of gastrointestinal complaints, not in pain, not diagnosed with a psychiatric disorder
  • Female
  • Aged: 45 - 65 years

Who cannot join

  • Having received treatment in the last 12 months for: depression, anxiety, neurological disease including migraine, dementia, epilepsy, Parkinson's.
  • History of any psychiatric or neurological illness in the last 2 years.
  • Current medication targeting the brain (except mild painkillers, e.g. pure paracetamol, ibuprofen), including steroids, e.g. for contraception, Hormone Replacement Therapy (HRT), drugs for weight control, stimulants (e.g. phenylephrine, ephedrine), antihistamines, and some herbal or nutritional remedies including St. John's Wort, 5-hydroxy-tryptophan, or melatonin (which can affect the serotonin system).
  • Pregnancy
  • Current gastrointestinal complaints
  • Diabetes (Type 1 or 2)
  • Body mass index < 18 or > 35

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • School of Human & Life Sciences

    London, London, SW15 4JD

Other trials in United Kingdom

About this study

Official title: Dietary Influence on Serotonin in Cognitive and Emotional Functioning in Women Using a Tryptophan-rich Protein Over 19 Days

The purpose of this study is to determine whether a chronic dose of a tryptophan-rich protein drink (lumiVida™) can improve cognitive function, emotional processing and sleep in middle-aged women. In addition, also genetic predictors of susceptibility to an increase of Trp levels will be investigated.

lumiVida™ is considered a dietary supplement, and therefore it is not an approved drug by the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug Administration does not strictly regulate herbs and dietary supplements. The investigators do not claim that this supplement is meant to treat any ailment

Read the detailed description

The treatment conditions are either placebo or lumiVida™ (N=30 per group) 0.5 g twice a day (total 1 g/ day). The first testing took place on the screening day (baseline). Subsequently, participants were supplied with supplements for 19 days intervention (sachets which had to be dissolved in 200-ml water). After 19 days, participants were tested again (same tests as on the baseline day). An additional facet was the completion of a 'sleep diary', which asks questions about sleep quality and latency, and bed-time mood, as well as allowing recording of timing of supplement taking.

Conditions
Healthy
Being tested
lumiVida™, Placebo
Keywords
lumiVida™, cognition, mood, sleep, tryptophane

What participants receive

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

  • lumiVida™Dietary supplement

  • PlaceboDietary supplement

Study groups in NCT02172859
Study groupRoleWhat they receive
lumiVida™Active comparatorlumiVida™ (2 x 0.5 g sachets to be dissolved in 150ml water/ day): First dose 2h after breakfast and second dose 60-90min before bed-time for 19 days.
Receives: Dietary Supplement: lumiVida™
PlaceboPlacebo comparatorPlacebo (2 x 0.5 g sachets of casein hydrolysate to be dissolved in 150ml water/ day): First dose 2h after breakfast and second dose 60-90min before bed-time for 19 days
Receives: Dietary Supplement: Placebo

What is being measured

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

  1. Change from baseline in measures of mood (MAPS scale) at day 19

    Computer-based series of 9-point ratings scales to measure mood

    Measured: Day1 (baseline) and day 19

  2. Change from baseline in sleep diaries until day 19

    Sleep diaries: Questions about sleep quality and latency, bed-time mood and alertness aspects.

    Measured: Day 1 and 2 prior treatment (baseline) and at day 1, 2, 4, 5, 11, 12, 18 and 19 of intake period

  3. Change from baseline in "Simple Reaction Time (SRT)" at day 19

    Measurement of reaction time and sustained attention

    Measured: Day 1 (baseline) and day 19

  4. Change from baseline in the "Rotary Pursuit Task" at day 19

    Measurement of psychomotor coordination and motor learning

    Measured: Day 1 (baseline) and day 19

  5. Change from baseline in "Verbal Recognition Memory test (VRM)" at day 19

    Recognition of words out of a list of words they have seen before

    Measured: Day 1 (baseline) and day 19

  6. Change from baseline in "Match To Sample Visual search (MTS)" at day 19

    Measurement of visual attention, and speed and accuracy of responding

    Measured: Day 1 (baseline) and day 19

  7. Change from baseline in "Rapid Visual Information Processing task (RVIP)" at day 19

    Assessment of sustained attention and working memory

    Measured: Day 1 (baseline) and at day 19

  8. Change from baseline in "Affective Go/No-Go" at day 19

    Assessment of information processing biases for positive and negative stimuli

    Measured: Day 1 (baseline) and day 19

  9. Change from baseline in "Emotion Recognition Task" at day 19

    Assessment of relatively enhanced recognition of positive emotional facial expressions on "morphed" photographs

    Measured: Day 1 (baseline) and day 19

  10. Change from baseline in "Driving Hazard Perception Test" at day 19

    Measurement of participant's ability to perceive accurately and react to potential hazards whilst driving: this will be measured by computer software that displays a video recording from the driver's perspective through the windscreen of a moving car.

    Measured: Day 1 (baseline) and day 19

Secondary outcomes (2)

  1. Genetic evaluation of genotypes of the serotonin transporter protein (5HTTP)

    Buccal (cheek) cell assays for DNA extraction for 5HTTP polymorphism analysis

    Measured: Baseline

  2. Change from baseline in plasma TRP/LNAA ratio at day 19

    Measurement of L-tryptophan (TRP) and large neutral amino acids (LNAA) amino acids in blood samples (plasma)

    Measured: Day 1 (baseline) and day 19

Timeline

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

  1. First posted24 Jun 2014 (estimated)
  2. Study startNov 2010
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02172859
Sponsor's protocol ID
P2B-05
Acronym
P2B_UK
Status last verified
Jun 2014
First submitted
23 Jun 2014
Last updated
24 Jun 2014
Results posted
No
Data monitoring committee
No

Publications

  • Leigh Gibson E, Green MW. Nutritional influences on cognitive function: mechanisms of susceptibility. Nutr Res Rev. 2002 Jun;15(1):169-206. doi: 10.1079/NRR200131.

    PubMed 19087403

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lumiVida™ in people with Healthy, run by dsm-firmenich Switzerland AG 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 7 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 24 Jun 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.

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?

Change from baseline in measures of mood (MAPS scale) at day 19 (time frame: Day1 (baseline) and day 19). The study lists 10 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 NCT02172859, which also lists 1 linked publication.

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 24 Jun 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in