Cognitive Function and MoodNCT02675582
Investigation of the Acute Calming Effects of Drinks Containing Herbal Extracts in Healthy Adults
A study testing Herbal Beverage in people with Cognitive Function and Mood, run by PepsiCo Global R&D at 1 site in United Kingdom.
Trial summary
The primary objectives of this study are to assess the effects of three investigational drinks containing three botanicals in differing combinations versus a placebo control, on mood, psychological state, physical response, and cognitive performance during and after exposure to an observed multi-tasking stressor. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function and Mood
- What is being tested?
- Herbal Beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 49 years
- Self-report of good health
- Are not excluded on the basis of the following exclusion criteria
Who cannot join
- Are a smoker
- Have food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff
- Currently take medication except the contraceptive pill
- Have habitually used dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total)
- Have sleep disturbances and/or are taking sleep aid medication Are employed in a job that includes night shift work
- Have a Body Mass Index (BMI) outside of the range 18-35 kg/m2or weigh less than 50kg or more than 85kg.
Show all 23Show fewer
- Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg)
- Have a history of neurological, vascular or psychiatric illness including epilepsy or seizures (excluding depressive illness and anxiety)
- Have a history of anxiety or a current diagnosis of anxiety or depression
- Are pregnant, trying to get pregnant or breast feeding
- Have a recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as more than 60g (men) / 40g (women) pure alcohol per day (7 / 5.5 units)
- Have learning difficulties or dyslexia
- Have visual impairment that cannot be corrected with glasses or contact lenses
- Have frequent migraines that require medication (more than or equal to 1 per month)
- Have disorders of the blood (e.g. anaemia, hemophilia, thrombocytosis)
- Have a heart disorder or a history of vascular illness
- Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study)
- Have a diagnosis of type I or type II diabetes
- Have a history of renal or hepatic disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalciuria), that are likely to interfere with metabolism/absorption/secretion of the product under investigation
- Have any health condition that would prevent fulfillment of the study requirements
- Are currently or have in the past 8weeks participated in other clinical or nutrition intervention studies
- Have participated in the BPNRC's recent stress study
- Do not have a bank account (required for payment)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, NE1 8ST
About this study
The primary objectives of this study are to assess the effects of three investigational drinks containing three botanicals in differing combinations versus a placebo control, on mood, psychological state, physical response, and cognitive performance during and after exposure to an observed multi-tasking stressor.
- Conditions
- Cognitive Function and Mood
- Being tested
- Herbal Beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal BeverageOther
Intervention involves consuming one beverage at the beginning of each visit during the incomplete block design sequence
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Mix 1 flavored still beverage Receives: Other: Herbal Beverage |
| Herbal beverage 1 | Experimental | Mix 2 flavored still beverage with a botanical extract(1) Receives: Other: Herbal Beverage |
| Herbal Beverage 2 | Experimental | Mix 3 flavored still beverage with a botanical extract(2) Receives: Other: Herbal Beverage |
| Combined Herbal Beverage | Experimental | Mix 4 flavored still beverage with 2 botanical extracts (1,2) Receives: Other: Herbal Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mood
During each assessment mood and psychological state will be assessed before and after performance of an observed multi-tasking stressor via completion of the 'State' subscale of the State-Trait Anxiety Inventory and computerised versions of the Bond-Lader visual analogue mood scales and separate visual analogue scales (VAS) measuring subjective stress, relaxation and calmness.
Measured: Pre dose, 60, 150, 240 min post dose
Secondary outcomes (1)
Change in Cognitive function
During each assessment mood and psychological state will be assessed before and after performance of an observed multi-tasking stressor via completion of the 'State' subscale of the State-Trait Anxiety Inventory and computerised versions of the Bond-Lader visual analogue mood scales and separate visual analogue scales (VAS) measuring subjective stress, relaxation and calmness.
Measured: Pre dose, 60, 150, 240 min post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startJun 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Function and MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northumbria University
- Responsible party
- Sponsor
- Investigators
- David Kennedy, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675582
- Sponsor's protocol ID
- PEP-1509
- Status last verified
- Sep 2018
- First submitted
- 21 Jan 2016
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Acute Calming Effects of Drinks Containing Herbal Extracts in Healthy Adults
- ClinicalTrials.gov ID
- NCT02675582
- Acronym / sponsor ID
- PEP-1509
- Conditions
- Cognitive Function and Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Collaborators
- Northumbria University
- Study start
- Jun 2015 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to assess the effects of three investigational drinks containing three botanicals in differing combinations versus a placebo control, on mood, psychological state, physical response, and cognitive performance during and after exposure to an observed multi-tasking stressor.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Herbal BeverageMix 1 flavored still beverage |
| Herbal beverage 1 | Experimental | Other: Herbal BeverageMix 2 flavored still beverage with a botanical extract(1) |
| Herbal Beverage 2 | Experimental | Other: Herbal BeverageMix 3 flavored still beverage with a botanical extract(2) |
| Combined Herbal Beverage | Experimental | Other: Herbal BeverageMix 4 flavored still beverage with 2 botanical extracts (1,2) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18 to 49 years
- Self-report of good health
- Are not excluded on the basis of the following exclusion criteria
Key exclusion criteria (23 listed)
- Are a smoker
- Have food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff
- Currently take medication except the contraceptive pill
- Have habitually used dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total)
- Have sleep disturbances and/or are taking sleep aid medication Are employed in a job that includes night shift work
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal BeverageIntervention involves consuming one beverage at the beginning of each visit during the incomplete block design sequence | Other | Combined Herbal Beverage, Control, Herbal Beverage 2, Herbal beverage 1 |
Primary outcome
Change in mood
Time frame: Pre dose, 60, 150, 240 min post dose
During each assessment mood and psychological state will be assessed before and after performance of an observed multi-tasking stressor via completion of the 'State' subscale of the State-Trait Anxiety Inventory and computerised versions of the Bond-Lader visual analogue mood scales and separate visual analogue scales (VAS) measuring subjective stress, relaxation and calmness.
1 secondary outcome
Change in Cognitive function
Time frame: Pre dose, 60, 150, 240 min post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kennedy, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herbal Beverage in people with Cognitive Function and Mood, run by PepsiCo Global R&D at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mood (time frame: Pre dose, 60, 150, 240 min post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.