Clinical trial NCT03262376: Minerals and Botanicals for Acute Stress
Official title: Acute Effect of Minerals and Botanicals in Combination or Isolation on Cognitive Performance, Neural Activity, and Subjective and Cortisol Response to Acute Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Anxiety
Keywords: Stress
Anxiety
Cortisol
Vitamins
Botanicals
Minerals
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oscillatory brain activity during the rested state and attentional processing (EEG; Biosemi Active2, 64-channel, DC amplifier, 24-bit resolution system)
timeFrame: 30 minute period, approximately 65 minutes post treatment intake
Secondary outcomes:
measure: Subjective stress (Stress & Arousal Checklist; Mackay et al., 1978)
timeFrame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
measure: Subjective mood (Profile of Mood States [MCNair et al., 1971] & Bond Visual analogue scales, 1974)
timeFrame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
measure: Subjective anxiety (Spielberger State Trait Anxiety Inventory, 1983)
timeFrame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
measure: Cognitive performance (Digit attention switching & threat vs neutral dot probe task)
timeFrame: 20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake
measure: Blood pressure
timeFrame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
measure: Heart rate
timeFrame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
measure: Salivary cortisol
timeFrame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
measure: Event related potentials (EEG; Biosemi Active2, 64-channel, DC amplifier, 24-bit resolution system)
timeFrame: 20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Human Appetite Research Unit, University of Leeds
state: West Yorkshire
Study officials:
affiliation: University of Leeds
name: Louise Dye, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boyle NB, Dye L, Lawton CL, Billington J. A Combination of Green Tea, Rhodiola, Magnesium, and B Vitamins Increases Electroencephalogram Theta Activity During Attentional Task Performance Under Conditions of Induced Social Stress. Front Nutr. 2022 Jul 22;9:935001. doi: 10.3389/fnut.2022.935001. eCollection 2022.
citation: Boyle NB, Billington J, Lawton C, Quadt F, Dye L. A combination of green tea, rhodiola, magnesium and B vitamins modulates brain activity and protects against the effects of induced social stress in healthy volunteers. Nutr Neurosci. 2022 Sep;25(9):1845-1859. doi: 10.1080/1028415X.2021.1909204. Epub 2021 Apr 26.