School of Human & Life Sciences
London, SW15 4JD, United Kingdom
NCT Number: NCT02172859
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
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Notify Me45 year–65 year
Female
Interventional
Phase 2
London, SW15 4JD, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day1 (baseline) and day 19
Computer-based series of 9-point ratings scales to measure mood
Time frame: Day 1 and 2 prior treatment (baseline) and at day 1, 2, 4, 5, 11, 12, 18 and 19 of intake period
Sleep diaries: Questions about sleep quality and latency, bed-time mood and alertness aspects.
Time frame: Day 1 (baseline) and day 19
Measurement of reaction time and sustained attention
Time frame: Day 1 (baseline) and day 19
Measurement of psychomotor coordination and motor learning
Time frame: Day 1 (baseline) and day 19
Recognition of words out of a list of words they have seen before
Time frame: Day 1 (baseline) and day 19
Measurement of visual attention, and speed and accuracy of responding
Time frame: Day 1 (baseline) and at day 19
Assessment of sustained attention and working memory
Time frame: Day 1 (baseline) and day 19
Assessment of information processing biases for positive and negative stimuli
Time frame: Day 1 (baseline) and day 19
Assessment of relatively enhanced recognition of positive emotional facial expressions on "morphed" photographs
Time frame: Day 1 (baseline) and 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: Baseline
Buccal (cheek) cell assays for DNA extraction for 5HTTP polymorphism analysis
Time frame: Day 1 (baseline) and day 19
Measurement of L-tryptophan (TRP) and large neutral amino acids (LNAA) amino acids in blood samples (plasma)
dsm-firmenich Switzerland AG
Industry
Dietary Influence on Serotonin in Cognitive and Emotional Functioning in Women Using a Tryptophan-rich Protein Over 19 Days
Acronym: P2B_UK
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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