Dietary Influence on Serotonin in Cognitive and Emotional Functioning in Women (P2B_UK)

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: lumiVida™

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW15 4JD
    • School of Human & Life Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: lumiVida™; 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™
Placebo Comparator: Placebo; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: DSM Nutritional Products, Inc.
• Investigators: Principal Investigator: Leigh Gibson, Dr., School of Human & Life Sciences, Roehampton University, Holybourne Avenue London SW15 4JD, UK

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: June 23, 2014
• First Submitted That Met QC Criteria: June 23, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Estimate): June 24, 2014
• Last Update Submitted That Met QC Criteria: June 23, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: lumiVida™, cognition, mood, sleep, tryptophane
• Other Study ID Numbers: P2B-05