Dietary Influence on Serotonin in Cognitive and Emotional Functioning in Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: lumiVida™
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lumiVida™<br>lumiVida™ (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. | Dietary Supplement: lumiVida™<br> <br> |
| Placebo Comparator: Placebo<br>Placebo (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 | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in measures of mood (MAPS scale) at day 19 | Computer-based series of 9-point ratings scales to measure mood | 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. | 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 | Day 1 (baseline) and day 19 | 
| Change from baseline in the Rotary Pursuit Task at day 19 | Measurement of psychomotor coordination and motor learning | 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 | 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 | 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 | 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 | 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 | 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. | Day 1 (baseline) and day 19 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic evaluation of genotypes of the serotonin transporter protein (5HTTP) | Buccal (cheek) cell assays for DNA extraction for 5HTTP polymorphism analysis | 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) | Day 1 (baseline) and day 19 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumiVida™, cognition, mood, sleep, tryptophane