Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mineral + vits + botanical A | Experimental | Mineral and vitamin complex combined with Botanical A |
|
| Mineral + vits + botanical B | Experimental | Mineral and vitamin complex combined with Botanical B |
|
| Mineral+vits +botanical A+Botanical B | Experimental | Mineral and vitamin complex combined with Botanical A and Botanical B |
|
| Placebo | Placebo Comparator | Cellulose crystalline placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minerals + Vitamins | Dietary Supplement | A mineral and vitamin tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Subjective mood (Profile of Mood States [MCNair et al., 1971] & Bond Visual analogue scales, 1974) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Louise Dye, PhD | University of Leeds | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Appetite Research Unit, University of Leeds | Leeds | West Yorkshire | LS29JT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35938130 | Derived | 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. | |
| 33896388 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D008903 | Minerals |
| D014815 | Vitamins |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
Not provided
Not provided
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
Not provided
Not provided
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.
| Botanical A | Dietary Supplement | Botanical extract administered in capsule form |
|
| Botanical B | Dietary Supplement | Botanical extract administered in capsule form |
|
| Placebo | Other | Cellulose crystalline tablet |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| D020164 | Chemical Actions and Uses |
| D000078622 | Nutrients |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |