Healthy Clinical Trial
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
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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