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

dsm-firmenich Switzerland AG2 个研究点分布在 1 个国家目标入组 59 人开始时间: 2010年11月1日最近更新: 2014年6月24日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 59
试验地点: 2
主要终点: Change from baseline in sleep diaries until day 19

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 45 Years 至 65 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•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
•Aged: 45 - 65 years

排除标准

•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

研究组 & 干预措施

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.

干预措施: lumiVida™ (Dietary Supplement)

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

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Change from baseline in sleep diaries until day 19

时间窗: 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.

Change from baseline in measures of mood (MAPS scale) at day 19

时间窗: Day1 (baseline) and day 19

Computer-based series of 9-point ratings scales to measure mood

Change from baseline in "Simple Reaction Time (SRT)" at day 19