Dietary Influence on Serotonin in Cognitive and Emotional Functioning in Women

DSM Nutritional Products, Inc.59 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Time frame: Day1 (baseline) and day 19

Change from baseline in sleep diaries until day 19

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

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

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

Measurement of reaction time and sustained attention

Time frame: Day 1 (baseline) and day 19

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

Measurement of psychomotor coordination and motor learning

Time frame: Day 1 (baseline) and day 19

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

Time frame: Day 1 (baseline) and day 19

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

Measurement of visual attention, and speed and accuracy of responding

Time frame: Day 1 (baseline) and day 19

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

Assessment of sustained attention and working memory

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

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

Assessment of information processing biases for positive and negative stimuli

Time frame: Day 1 (baseline) and day 19

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

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

Time frame: Day 1 (baseline) and day 19

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.

Time frame: Day 1 (baseline) and day 19

Secondary Outcomes

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

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

Time frame: Baseline

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)

Time frame: Day 1 (baseline) and day 19

Dietary Influence on Serotonin in Cognitive and Emotional Functioning in Women

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes