Anxiety, Stress
Conditions
Keywords
Stress, Anxiety, Cortisol, Vitamins, Botanicals, Minerals
Brief summary
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
Detailed description
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.
Interventions
OTHERPlacebo
Cellulose crystalline tablet
DIETARY_SUPPLEMENTMinerals + Vitamins
A mineral and vitamin tablet
DIETARY_SUPPLEMENTBotanical A
Botanical extract administered in capsule form
DIETARY_SUPPLEMENTBotanical B
Botanical extract administered in capsule form
Sponsors
University of Leeds
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
This study is double-blinded. The supplement manufacturer will independently create codes for the 4 treatment conditions. The study statistician will use the treatment codes generated to allocate participants to treatments. Researchers and participants will be blind treatment allocation.
Intervention model description
The study conforms to a double blind, quasi-randomised (randomisation will be balanced across condition based on age and sex), placebo controlled, parallel group design comprising 4 treatment conditions
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults capable of giving informed consent * Male and Female * ≥18 - ≤50 years of age (premenopausal if female) * Effective contraception taken in females * Women in luteal menstrual phase * Body mass index (BMI) ≥18 and ≤30 kg/m2 * Normal vision or corrected to normal * Moderately stressed (subjective report)
Exclusion criteria
* No known intolerance to minerals, vitamins or botanicals * Intake of prescribed medication except contraceptives * Intake of any regular medication/supplements * History of significant hypertensive, hepatic, renal, pulmonary, gastro-intestinal, endocrinological, neurologic, haematological, psychiatric (inc. mood disorders), cardiac or allergic disease which is clinically relevant to the study * Hypertension (self-report or resting blood pressure \>160/95 mmHg) * Diabetes (T1 or T2) * Smoking more than occasional cigarettes (\>5/day) * Pregnant or lactating * Previous participation in a stress study involving the Trier Social Stress Test * Night-working/shift work * Recreational drug use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oscillatory brain activity during the rested state and attentional processing (EEG; Biosemi Active2, 64-channel, DC amplifier, 24-bit resolution system) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective mood (Profile of Mood States [MCNair et al., 1971] & Bond Visual analogue scales, 1974) | 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 |
| Subjective anxiety (Spielberger State Trait Anxiety Inventory, 1983) | 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 |
| Cognitive performance (Digit attention switching & threat vs neutral dot probe task) | 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 |
| Subjective stress (Stress & Arousal Checklist; Mackay et al., 1978) | 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 |
| Heart rate | 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 |
| Salivary cortisol | 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 |
| Event related potentials (EEG; Biosemi Active2, 64-channel, DC amplifier, 24-bit resolution system) | 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 |
| Blood pressure | 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 |
Countries
United Kingdom
Outcome results
None listed