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Completed

NCT Number: NCT02172859

Dietary Influence on Serotonin in Cognitive and Emotional Functioning in Women

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

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Key information

Conditions

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

School of Human & Life Sciences

London, SW15 4JD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

lumiVida™

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

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

    Time frame: Day1 (baseline) and day 19

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

  2. Change from baseline in sleep diaries until day 19

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

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

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

    Time frame: Day 1 (baseline) and day 19

    Measurement of reaction time and sustained attention

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

    Time frame: Day 1 (baseline) and day 19

    Measurement of psychomotor coordination and motor learning

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

    Time frame: Day 1 (baseline) and day 19

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

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

    Time frame: Day 1 (baseline) and day 19

    Measurement of visual attention, and speed and accuracy of responding

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

    Time frame: Day 1 (baseline) and at day 19

    Assessment of sustained attention and working memory

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

    Time frame: Day 1 (baseline) and day 19

    Assessment of information processing biases for positive and negative stimuli

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

    Time frame: Day 1 (baseline) and day 19

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

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

    Time frame: Day 1 (baseline) and 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.

Secondary outcomes

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

    Time frame: Baseline

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

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

    Time frame: Day 1 (baseline) and day 19

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

Sponsors and collaborators

Lead sponsor

dsm-firmenich Switzerland AG

Industry

Registry information

Official study title

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

Acronym: P2B_UK

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 24, 2014
Registry last updated
Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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