Acute Effect of Minerals and Botanicals in Combination or Isolation on Cognitive Performance, Neural Activity, and Subjective and Cortisol Response to Acute Stress
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Leeds
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Oscillatory brain activity during the rested state and attentional processing (EEG; Biosemi Active2, 64-channel, DC amplifier, 24-bit resolution system)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, 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.
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Mineral + vits + botanical A
Mineral and vitamin complex combined with Botanical A
Intervention: Minerals + Vitamins (Dietary Supplement)
Mineral + vits + botanical A
Mineral and vitamin complex combined with Botanical A
Intervention: Botanical A (Dietary Supplement)
Mineral + vits + botanical B
Mineral and vitamin complex combined with Botanical B
Intervention: Minerals + Vitamins (Dietary Supplement)
Mineral + vits + botanical B
Mineral and vitamin complex combined with Botanical B
Intervention: Botanical B (Dietary Supplement)
Mineral+vits +botanical A+Botanical B
Mineral and vitamin complex combined with Botanical A and Botanical B
Intervention: Minerals + Vitamins (Dietary Supplement)
Mineral+vits +botanical A+Botanical B
Mineral and vitamin complex combined with Botanical A and Botanical B
Intervention: Botanical A (Dietary Supplement)
Mineral+vits +botanical A+Botanical B
Mineral and vitamin complex combined with Botanical A and Botanical B
Intervention: Botanical B (Dietary Supplement)
Placebo
Cellulose crystalline placebo
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Oscillatory brain activity during the rested state and attentional processing (EEG; Biosemi Active2, 64-channel, DC amplifier, 24-bit resolution system)
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
Secondary Outcomes
- Subjective anxiety (Spielberger State Trait Anxiety Inventory, 1983)(Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake)
- 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)
- 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)
- Blood pressure(Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake)
- Salivary cortisol(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)(20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake)
- Heart rate(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)(20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake)
Investigators
Prof Louise Dye
Professor of Nutrition and Behaviour
University of Leeds