Status:
COMPLETED
Minerals and Botanicals for Acute Stress
Lead Sponsor:
University of Leeds
Conditions:
Stress
Anxiety
Eligibility:
All Genders
18-50 years
Phase:
NA
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 p...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03262376
Start Date
December 4 2017
End Date
December 12 2018
Last Update
January 7 2019
Active Locations (1)
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1
Human Appetite Research Unit, University of Leeds
Leeds, West Yorkshire, United Kingdom, LS29JT