NCT02172859

Dietary Influence on Serotonin in Cognitive and Emotional Functioning in Women

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: dsm-firmenich Switzerland AG · Industry
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	lumiVida™
DIETARY_SUPPLEMENT	Placebo

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2014-06-24
• Last updated: 2014-06-24

Locations

1 site across 1 country: United Kingdom