This is a single center, randomized, double blind, placebo-controlled, crossover study to determine the acute effect of a developmental dietary supplement liquid shot product of aspect of mood both at rest and during laboratory stressor task. The study will be conducted in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
48
60ml functional energy shot contained a proprietary blend of L-theanine, chamomile, lemon balm, ginseng and vitamins
Placebo 60 ml Shot, matched in volume, taste and colour and but did not contain any active ingredients
Sago London
London, United Kingdom
Change from Baseline in the State-Trait Anxiety Inventory up to 135 minutes for the functional shot versus placebo shot.
The STAI 'State' subscale contains 6 statements each responded to with a 4-point Likert scale. Scores range from 6-24, where higher scores indicate higher anxiety.
Time frame: From Baseline to 135 minutes post trial product consumption
Change from Baseline in Mood via Visual Analogue Mood Scales (VAMS) up to 135 minutes for the functional shot versus placebo shot.
Comprising of 18 visual analogue scales anchored by pairs of antonymic mood/state adjectives (e.g. Alert - Inattentive; Lethargic - Energetic) on 0-100% line. The individual item scores are combined to give an average (% along the line) score on three factors that had previously been derived by factor analysis: 'Alertness', 'Tranquility' and 'Stress'. Higher scores indicate a higher level of each factor.
Time frame: From Baseline to 135 minutes post trial product consumption
Change from Baseline in Mood via Visual Analogue Scales (VAS) up to 135 minutes for the functional shot versus placebo shot.
0-100 mm subjective rating scale from none to strongest feelings, for clam, sleepy, nervous and in control. Higher scores indicate a higher level of each factor.
Time frame: From Baseline to 135 minutes post trial product consumption
Change from Baseline in physiological state via POMS up to 135 minutes for the functional shot versus placebo shot.
a 37-item inventory, the individual item scores of which are collapsed into six dimensions of mood: anger/hostility, confusion/bewilderment, depression/dejection, fatigue/inertia, tension/anxiety, and vigour/activity. Higher scores indicate a higher level of each factor.
Time frame: From Baseline to 135 minutes post trial product consumption
Change from Baseline in physiological state via Self-Assessment Manikin up to 135 minutes for the functional shot versus placebo shot.
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The three single-item scales, each comprising nine simple line-drawn human figures with titrated emotional connotations, measure the participants current emotional position between happiness and sadness (Pleasure scale), relaxed and excited (Arousal scale), and feeling no-control to feeling in full-control (Dominance scale). Higher scores indicate a higher level of each factor.
Time frame: From Baseline to 135 minutes post trial product consumption