Minerals and Botanicals for Acute Stress

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03262376
• Other study ID #: IIT15073
• Status: Completed
• Phase: N/A
• Start date: December 4, 2017
• Est. completion date: December 12, 2018

Study information

• Verified date: January 2019
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 12, 2018
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Stress

Intervention

Dietary Supplement:
• Minerals + Vitamins
A mineral and vitamin tablet
• Botanical A
Botanical extract administered in capsule form
• Botanical B
Botanical extract administered in capsule form

Other:
• Placebo
Cellulose crystalline tablet

Locations

Country	Name	City	State
United Kingdom	Human Appetite Research Unit, University of Leeds	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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