Dietary Influence on Serotonin in Cognitive and Emotional Functioning in Women

Healthy Clinical Trial

— P2B_UK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02172859
• Other study ID #: P2B-05
• Status: Completed
• Phase: Phase 2
• First received: June 23, 2014
• Last updated: June 23, 2014
• Start date: November 2010
• Est. completion date: July 2011

Study information

• Verified date: June 2014
• Source: DSM Nutritional Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• lumiVida™

• Placebo

Locations

Country	Name	City	State
United Kingdom	School of Human & Life Sciences	London

Sponsors (1)

Lead Sponsor	Collaborator
DSM Nutritional Products, Inc.

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Change from baseline in "Simple Reaction Time (SRT)" at day 19	Measurement of reaction time and sustained attention	Day 1 (baseline) and day 19	No
Primary	Change from baseline in the "Rotary Pursuit Task" at day 19	Measurement of psychomotor coordination and motor learning	Day 1 (baseline) and day 19	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Genetic evaluation of genotypes of the serotonin transporter protein (5HTTP)	Buccal (cheek) cell assays for DNA extraction for 5HTTP polymorphism analysis	Baseline	No
Secondary	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	No