Clinical trial NCT02172859: Dietary Influence on Serotonin in Cognitive and Emotional Functioning in Women
Official title: Dietary Influence on Serotonin in Cognitive and Emotional Functioning in Women Using a Tryptophan-rich Protein Over 19 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: lumiVida™, cognition, mood, sleep, tryptophane
Lead sponsor: DSM Nutritional Products, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-24
Enrollment: 59
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in measures of mood (MAPS scale) at day 19
timeFrame: Day1 (baseline) and day 19
measure: Change from baseline in sleep diaries until day 19
timeFrame: Day 1 and 2 prior treatment (baseline) and at day 1, 2, 4, 5, 11, 12, 18 and 19 of intake period
measure: Change from baseline in "Simple Reaction Time (SRT)" at day 19
timeFrame: Day 1 (baseline) and day 19
measure: Change from baseline in the "Rotary Pursuit Task" at day 19
timeFrame: Day 1 (baseline) and day 19
measure: Change from baseline in "Verbal Recognition Memory test (VRM)" at day 19
timeFrame: Day 1 (baseline) and day 19
measure: Change from baseline in "Match To Sample Visual search (MTS)" at day 19
timeFrame: Day 1 (baseline) and day 19
measure: Change from baseline in "Rapid Visual Information Processing task (RVIP)" at day 19
timeFrame: Day 1 (baseline) and at day 19
measure: Change from baseline in "Affective Go/No-Go" at day 19
timeFrame: Day 1 (baseline) and day 19
measure: Change from baseline in "Emotion Recognition Task" at day 19
timeFrame: Day 1 (baseline) and day 19
measure: Change from baseline in "Driving Hazard Perception Test" at day 19
timeFrame: Day 1 (baseline) and day 19
Secondary outcomes:
measure: Genetic evaluation of genotypes of the serotonin transporter protein (5HTTP)
timeFrame: Baseline
measure: Change from baseline in plasma TRP/LNAA ratio at day 19
timeFrame: Day 1 (baseline) and day 19
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: School of Human & Life Sciences
Study officials:
affiliation: School of Human & Life Sciences, Roehampton University, Holybourne Avenue London SW15 4JD, UK
name: Leigh Gibson, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.