Minerals and Botanicals for Acute Stress

Not Applicable

Completed

• Conditions: Anxiety; Stress
• Interventions: Dietary Supplement: Minerals + Vitamins; Other: Placebo; Dietary Supplement: Botanical A; Dietary Supplement: Botanical B

• Registration Number: NCT03262376
• Lead Sponsor: University of Leeds

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 Timeline

• Study First Submitted: 2017-08-14
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-25
• Study Start: 2017-12-04
• Primary Completion: 2018-12-12
• Study Completion: 2018-12-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mineral+vits +botanical A+Botanical B	Botanical A	Mineral and vitamin complex combined with Botanical A and Botanical B
Mineral + vits + botanical A	Botanical A	Mineral and vitamin complex combined with Botanical A
Mineral + vits + botanical A	Minerals + Vitamins	Mineral and vitamin complex combined with Botanical A
Mineral+vits +botanical A+Botanical B	Minerals + Vitamins	Mineral and vitamin complex combined with Botanical A and Botanical B
Placebo	Placebo	Cellulose crystalline placebo
Mineral + vits + botanical B	Minerals + Vitamins	Mineral and vitamin complex combined with Botanical B
Mineral + vits + botanical B	Botanical B	Mineral and vitamin complex combined with Botanical B
Mineral+vits +botanical A+Botanical B	Botanical B	Mineral and vitamin complex combined with Botanical A and Botanical B

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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
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
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
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
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

Trial Locations

Locations (1)

Human Appetite Research Unit, University of Leeds; 🇬🇧 Leeds, West Yorkshire, United Kingdom