An interventional study of Minerals + Vitamins and Botanical A in Stress and Anxiety, sponsored by University of Leeds. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-07.
Sponsored by University of Leeds · Not applicable, Interventional, and Treatment
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.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Leeds is the lead sponsor of 206 studies on the registry; 25 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mineral and vitamin complex combined with Botanical A
Dietary Supplement: Minerals + Vitamins · Dietary Supplement: Botanical A
Mineral and vitamin complex combined with Botanical B
Dietary Supplement: Minerals + Vitamins · Dietary Supplement: Botanical B
Mineral and vitamin complex combined with Botanical A and Botanical B
Dietary Supplement: Minerals + Vitamins · Dietary Supplement: Botanical A · Dietary Supplement: Botanical B
Cellulose crystalline placebo
Other: Placebo
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
Time frame: 30 minute period, approximately 65 minutes post treatment intake
Subjective stress (Stress & Arousal Checklist; Mackay et al., 1978)
The effect of treatment on subjective stress responses to stress induction
Time frame: 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)
The effect of treatment on subjective mood responses to stress induction
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake
Plan to share: No
Ran from Dec 2017 to primary completion in Dec 2018, 12 months.
Of 3,836 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 12 months is close to that.
Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Minerals · Vitamins