The goal of this study is to investigate if a food ingredient can improve stress in healthy adults who experience moderate symptoms of self-reported stress. The main question it aims to answer is if 4 weeks of daily intake of the ingredient reduces stress compared to 4 weeks of daily intake of a placebo product. Participants will: * consume both the test and placebo products for 4-weeks each in a randomised order, with 4 weeks in between * visit the test site 6 times over the 13 weeks * complete a series of assessments on stress and sleep quality and provide blood, stool and saliva samples
A double-blind, randomised, placebo-controlled, crossover study with 6 visits over 13-weeks. Participants will consume study product or placebo for two 4-week intervention periods. Primary Objective: To evaluate in healthy adults, experiencing moderate symptoms of self-reported stress, the effect of 4-week daily supplementation of a food ingredient versus placebo on stress. Secondary Objectives: To evaluate in healthy adults, experiencing moderate symptoms of self-reported stress, the effect of 4-week daily supplementation of a food ingredient versus placebo on: * Mood * Plasma GABA levels * Salivary cortisol awakening response (CAR) * Acute effects on stress * Faecal GABA
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
49
Atlantia Clinical Trials
Cork, Co Cork, Ireland
Change in Perceived Stress Scale (PSS) Total Score from baseline to end of intervention
The PSS is a self-reported measure of stress. The questions in this scale ask about participants feelings and thoughts during the last month. Respondents are asked how often they felt a certain way on a five-point scale from 'never' to 'very often'. It is a 10-item questionnaire and has a total score which correlates with one of three score categories (low stress \[0-13\], moderate stress \[14-26\]and high stress
Time frame: 4 weeks
Profile of Mood States Questionnaire (POMS)
POMS is a psychological rating scale used to assess transient, distinct mood states. It has seven subscales, including tension-anxiety, depression-dejection, anger-hostility, vigour-activity, fatigue-inertia, confusion-bewilderment, and friendliness. The researcher combines these scores to provide an overall measure called total mood disturbance.
Time frame: 4 weeks
Plasma GABA levels
Levels of Gamma-aminobutyric Acid in plasma
Time frame: 4 weeks
Salivary cortisol awakening response
c) Salivary cortisol awakening response at T0, T30, T45, T60 minutes
Time frame: 4 weeks
VAS scale on acute effects on stress
The VAS (visual analogue scale) is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the parameter measured, e.g., the left end = no stress, and the right end = extreme stress
Time frame: 30 hours
Faecal GABA quantification
Absolute quantification
Time frame: 4 weeks
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