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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lumiVida™ | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lumiVida™ | Dietary Supplement |
| ||
| Placebo |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leigh Gibson, Dr. | School of Human & Life Sciences, Roehampton University, Holybourne Avenue London SW15 4JD, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Human & Life Sciences | London | London | SW15 4JD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19087403 | Background | Leigh Gibson E, Green MW. Nutritional influences on cognitive function: mechanisms of susceptibility. Nutr Res Rev. 2002 Jun;15(1):169-206. doi: 10.1079/NRR200131. |
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| ID | Term |
|---|---|
| C000609744 | LumiVida |
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|
| 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 |
Measurement of L-tryptophan (TRP) and large neutral amino acids (LNAA) amino acids in blood samples (plasma)
| Day 1 (baseline) and day 19 |