Minerals and Botanicals for Acute Stress

University of Leeds

Status: Completed

Conditions: Anxiety; Stress

Treatments: Other: Placebo; Dietary Supplement: Botanical B; Dietary Supplement: Minerals + Vitamins; Dietary Supplement: Botanical A

Study type: Interventional

Funder types: Other

Identifiers

NCT03262376

IIT15073

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 4 patient groups, including a placebo group

Mineral + vits + botanical A

Experimental group

Description:

Mineral and vitamin complex combined with Botanical A

Treatment:

Dietary Supplement: Botanical A

Dietary Supplement: Minerals + Vitamins

Mineral + vits + botanical B

Experimental group

Description:

Mineral and vitamin complex combined with Botanical B

Treatment:

Dietary Supplement: Botanical B

Dietary Supplement: Minerals + Vitamins

Mineral+vits +botanical A+Botanical B

Experimental group

Description:

Mineral and vitamin complex combined with Botanical A and Botanical B

Treatment:

Dietary Supplement: Botanical B

Dietary Supplement: Botanical A

Dietary Supplement: Minerals + Vitamins

Placebo

Placebo Comparator group

Description:

Cellulose crystalline placebo

Treatment:

Other: Placebo