Human Appetite Research Unit, University of Leeds
Leeds, West Yorkshire, LS29JT, United Kingdom
NCT Number: NCT03262376
The objective of this acute intervention study is to examine the potential of minerals combined with botanicals to demonstrate unique and synergistic effects on oscillatory brain activity, cognitive performance, and stress reduction (endocrine, sympathetic, and subjective parameters) under conditions of acute stress in moderately stressed individuals
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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Leeds, West Yorkshire, LS29JT, United Kingdom
Botanicals in isolation or combined, will be administered with a mineral and vitamin complex to moderately stressed, healthy adults in a parallel groups fashion in this randomised placebo controlled trial. Oscillatory brain activity (EEG) during rest and performance on cognitive tasks of attention will be examined after treatment intake under conditions of acute laboratory stress. The effects of treatments on stress responses (cardiovascular, subjective and cortisol responses) will also be assessed.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A mineral and vitamin tablet
Botanical extract administered in capsule form
Botanical extract administered in capsule form
Cellulose crystalline tablet
Time frame: 30 minute period, approximately 65 minutes post treatment intake
The effect of treatment on oscillatory brain activity during the rested state and during attentional task processing after stress exposure
Time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
The effect of treatment on subjective stress responses to stress induction
Time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
The effect of treatment on subjective mood responses to stress induction
Time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
The effect of treatment on subjective anxiety responses to stress induction
Time frame: 20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake
The effect of treatment on reaction time and accuracy performance on two cognitive tasks of attention
Time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
The effect of treatment on blood pressure responses to stress induction
Time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
The effect of treatment on heart rate variability before and after stress induction
Time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
The effect of treatment on salivary cortisol responses to stress induction
Time frame: 20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake
The effect of treatment on event related potentials during execution of attentional processing
University of Leeds
Other
Acute Effect of Minerals and Botanicals in Combination or Isolation on Cognitive Performance, Neural Activity, and Subjective and Cortisol Response to Acute Stress
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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