Minerals and Botanicals for Acute Stress

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acute Effect of Minerals and Botanicals in Combination or Isolation on Cognitive Performance, Neural Activity, and Subjective and Cortisol Response to Acute Stress

Conditions
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Anxiety, Stress

Intervention / Treatment
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* Dietary Supplement: Minerals + Vitamins
* Dietary Supplement: Botanical A
* Dietary Supplement: Botanical B
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mineral + vits + botanical A<br>Mineral and vitamin complex combined with Botanical A | Dietary Supplement: Minerals + Vitamins<br>* A mineral and vitamin tablet<br>Dietary Supplement: Botanical A<br>* Botanical extract administered in capsule form<br>|
| Experimental: Mineral + vits + botanical B<br>Mineral and vitamin complex combined with Botanical B | Dietary Supplement: Minerals + Vitamins<br>* A mineral and vitamin tablet<br>Dietary Supplement: Botanical B<br>* Botanical extract administered in capsule form<br>|
| Experimental: Mineral+vits +botanical A+Botanical B<br>Mineral and vitamin complex combined with Botanical A and Botanical B | Dietary Supplement: Minerals + Vitamins<br>* A mineral and vitamin tablet<br>Dietary Supplement: Botanical A<br>* Botanical extract administered in capsule form<br>Dietary Supplement: Botanical B<br>* Botanical extract administered in capsule form<br>|
| Placebo Comparator: Placebo<br>Cellulose crystalline placebo | Other: Placebo<br>* Cellulose crystalline tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oscillatory brain activity during the rested state and attentional processing (EEG; Biosemi Active2, 64-channel, DC amplifier, 24-bit resolution system) | The effect of treatment on oscillatory brain activity during the rested state and during attentional task processing after stress exposure | 30 minute period, approximately 65 minutes post treatment intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective stress (Stress & Arousal Checklist; Mackay et al., 1978) | The effect of treatment on subjective stress responses to stress induction | Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake | 
| Subjective mood (Profile of Mood States [MCNair et al., 1971] & Bond Visual analogue scales, 1974) | The effect of treatment on subjective mood responses to stress induction | Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake | 
| Subjective anxiety (Spielberger State Trait Anxiety Inventory, 1983) | The effect of treatment on subjective anxiety responses to stress induction | Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake | 
| Cognitive performance (Digit attention switching & threat vs neutral dot probe task) | The effect of treatment on reaction time and accuracy performance on two cognitive tasks of attention | 20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake | 
| Blood pressure | The effect of treatment on blood pressure responses to stress induction | Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake | 
| Heart rate | The effect of treatment on heart rate variability before and after stress induction | Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake | 
| Salivary cortisol | The effect of treatment on salivary cortisol responses to stress induction | Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake | 
| Event related potentials (EEG; Biosemi Active2, 64-channel, DC amplifier, 24-bit resolution system) | The effect of treatment on event related potentials during execution of attentional processing | 20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, Anxiety, Cortisol, Vitamins, Botanicals, Minerals