Last updated: April 23, 2024
Sponsor: Northumbria University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Stress
Treatment
Placebo
Active
Clinical Study ID
NCT06109922
66CH2
Ages 25-49 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participant must self-assess themselves as being in good health
- Participant must be aged 25 to 49 years at the time of giving consent
- Participants first language is English or are fluent in English
Exclusion
Exclusion Criteria:
- Have any pre-existing medical conditions/illness which will impact taking part in thestudy. Cases can be looked at case-by-case.
- Are currently taking any prescription medications (NOTE the explicit exceptions tothis are contraceptive treatments for female participants, and those taking "asneeded" in the treatment of asthma and/or hay fever)
- Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg). NOTE:that we must measure this in the lab using our blood pressure monitors and can onlyuse our measurements to assess eligibility rather than home or doctors readings
- Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2.
- Are pregnant, seeking to become pregnant or lactating.
- Have been diagnosed with a neurological condition, or assessed as having alearning/behavioral or neurodevelopmental difference (e.g. dyslexia, autism, ADHD)
- Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
- Smoke tobacco or vape nicotine or use nicotine replacement products (if you haverecently quit smoking or using replacements you must have stopped using themaltogether for a period of 3 months before participating in this study)
- Have excessive caffeine intake (>500 mg per day). Note: This will be calculated atscreening but feel free to query this with the researcher prior to attendance
- Have relevant food allergies/ intolerance/ sensitivities
- Have taken antibiotics within the past 4 weeks.
- Have taken dietary supplements e.g., vitamins, omega 3 fish oils etc. in the last 4weeks . (Note: participation is possible following a 4 week wash out prior toparticipating and for the duration of the study on the proviso that the supplementsthey are taking are out of choice and not medically prescribed or advised. Pleasediscuss with the researcher if unsure. NOTE: we would never advise stoppingsupplements prescribed by your doctor e.g. iron, calcium etc, only those out ofchoice).
- Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
- Are unable to complete all of the study assessments
- Are currently participating in other clinical or nutrition intervention studies, orhave in the past 4 weeks
- Have been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months.
- Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months, including a medical diagnosis of anxiety or depression.
- Suffers from frequent migraines that require medication (more than or equal to 1 permonth)
- Have any sleep disorders or take any sleep medications.
- Have any known active infections.
- Does not have a bank account (required for payment)
- Are non-compliant with regards treatment consumption
- Follow an "extreme" diet. i.e., high fat, low sugar, low carb, high protein, paleo etc
- Are planning a major lifestyle change regarding diet or exercise regime in the next 3months.
- Are unable to meet the minimum requirement scores on the cognitive tasks.
- Experienced an event (professional or personal) that is likely to have impacted youremotional and/or psychological state within the last 8-10 weeks (for example but notrestricted to change of professional function, death of a family member, divorce,surgery, accident etc)
- Have an upcoming event (personal or professional) that is likely to affect youremotional, psychological state or hormonal state planned during the next 8-10 weeks,including but not limited to job change, house move, important medical exam etc.
- Have a current diagnosis of renal impairments or phenylketonuria
Study Design
Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
January 02, 2024
Estimated Completion Date:
October 01, 2024
Study Description
Connect with a study center
Northumbria University
Newcastle Upon Tyne,
United KingdomActive - Recruiting
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