Dietary Influence on Serotonin in Cognitive and Emotional Functioning in Women

NCT02172859 | Completed Phase 2

• 1 other identifier: P2B-05
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy

Keywords

lumiVida™, cognition, mood, sleep, tryptophane

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (2)

• Genetic evaluation of genotypes of the serotonin transporter protein (5HTTP)

  Baseline

• Change from baseline in plasma TRP/LNAA ratio at day 19

  Day 1 (baseline) and day 19

Study Arms (2)

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.

Dietary Supplement: lumiVida™

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

Dietary Supplement: Placebo

Interventions

lumiVida™ DIETARY_SUPPLEMENT

lumiVida™

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DSM Nutritional Products, Inc.: lead

Study Sites (1)

School of Human & Life Sciences

London, London, SW15 4JD, United Kingdom

Location

Related 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.

  PMID: 19087403 BACKGROUND

MeSH Terms

Interventions

LumiVida

Study Officials

• Leigh Gibson, Dr.

  School of Human & Life Sciences, Roehampton University, Holybourne Avenue London SW15 4JD, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: June 24, 2014
• Study Start: November 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: June 24, 2014

Record last verified: 2014-06

Locations

GB (1)