Minerals and Botanicals for Acute Stress

NCT03262376 | Completed

• 1 other identifier: IIT15073
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Stress; Anxiety

Keywords

Stress; Anxiety; Cortisol; Vitamins; Botanicals; Minerals

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

• Subjective anxiety (Spielberger State Trait Anxiety Inventory, 1983)

  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)

  20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake

• Blood pressure

  Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake

Study Arms (4)

Mineral + vits + botanical A

EXPERIMENTAL

Mineral and vitamin complex combined with Botanical A

Dietary Supplement: Minerals + Vitamins; Dietary Supplement: Botanical A

Mineral + vits + botanical B

EXPERIMENTAL

Mineral and vitamin complex combined with Botanical B

Dietary Supplement: Minerals + Vitamins; Dietary Supplement: Botanical B

Mineral+vits +botanical A+Botanical B

EXPERIMENTAL

Mineral and vitamin complex combined with Botanical A and Botanical B

Dietary Supplement: Minerals + Vitamins; Dietary Supplement: Botanical A; Dietary Supplement: Botanical B

Placebo

PLACEBO COMPARATOR

Cellulose crystalline placebo

Other: Placebo

Interventions

Minerals + Vitamins DIETARY_SUPPLEMENT

A mineral and vitamin tablet

Mineral + vits + botanical A; Mineral + vits + botanical B; Mineral+vits +botanical A+Botanical B

Botanical A DIETARY_SUPPLEMENT

Botanical extract administered in capsule form

Mineral + vits + botanical A; Mineral+vits +botanical A+Botanical B

Botanical B DIETARY_SUPPLEMENT

Botanical extract administered in capsule form

Mineral + vits + botanical B; Mineral+vits +botanical A+Botanical B

Placebo OTHER

Cellulose crystalline tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

Human Appetite Research Unit, University of Leeds

Leeds, West Yorkshire, LS29JT, United Kingdom

Location

Related Publications (2)

• Boyle NB, Dye L, Lawton CL, Billington J. A Combination of Green Tea, Rhodiola, Magnesium, and B Vitamins Increases Electroencephalogram Theta Activity During Attentional Task Performance Under Conditions of Induced Social Stress. Front Nutr. 2022 Jul 22;9:935001. doi: 10.3389/fnut.2022.935001. eCollection 2022.

  PMID: 35938130 DERIVED

• Boyle NB, Billington J, Lawton C, Quadt F, Dye L. A combination of green tea, rhodiola, magnesium and B vitamins modulates brain activity and protects against the effects of induced social stress in healthy volunteers. Nutr Neurosci. 2022 Sep;25(9):1845-1859. doi: 10.1080/1028415X.2021.1909204. Epub 2021 Apr 26.

  PMID: 33896388 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Minerals; Vitamins

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Louise Dye, PhD

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This study is double-blinded. The supplement manufacturer will independently create codes for the 4 treatment conditions. The study statistician will use the treatment codes generated to allocate participants to treatments. Researchers and participants will be blind treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition and Behaviour

Model Details: The study conforms to a double blind, quasi-randomised (randomisation will be balanced across condition based on age and sex), placebo controlled, parallel group design comprising 4 treatment conditions

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 25, 2017
• Study Start: December 4, 2017
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: January 7, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)