Minerals and Botanicals for Acute Stress

University of Leeds100 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Stress Anxiety

Interventions

Minerals + VitaminsDIETARY_SUPPLEMENT

A mineral and vitamin tablet

Botanical ADIETARY_SUPPLEMENT

Botanical extract administered in capsule form

Botanical BDIETARY_SUPPLEMENT

Botanical extract administered in capsule form

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Human Appetite Research Unit, University of Leeds

Leeds, West Yorkshire, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 30 minute period, approximately 65 minutes post treatment intake

Secondary Outcomes

Subjective stress (Stress & Arousal Checklist; Mackay et al., 1978)

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

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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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