Investigating the Effects of Dietary Phospholipids on Stress Reactivity and Recovery

Launched by NORTHUMBRIA UNIVERSITY · Oct 25, 2023

Keywords

ClinConnect Summary

This study is looking at how a special protein drink, which contains dairy phospholipids, can affect how the body responds to stress and how quickly it can recover from stress. Researchers want to see if drinking this protein powder daily for 6 to 12 weeks can help healthy adults manage stress better. Participants will be asked to mix the protein powder with water and drink it every day. They will also take part in stress tests in a lab and answer questions about their feelings of anxiety and stress. The study will include 150 adults aged 25 to 49 who are in good health.

To join the study, you need to be between 25 and 49 years old and consider yourself healthy. You'll be randomly given either the protein drink or a placebo (a drink that doesn’t contain the active ingredient) for the study. You will keep a diary to track when you take the drink, and you'll visit the research center for stress testing. There are several health conditions and medications that may prevent someone from participating, so it's important to discuss your health history with the researchers. Overall, this study aims to provide insights into how a specific dietary supplement might help with stress management.

Gender

ALL

Eligibility criteria

• 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 Criteria:
• • Have any pre-existing medical conditions/illness which will impact taking part in the study. Cases can be looked at case-by-case.
• • Are currently taking any prescription medications (NOTE the explicit exceptions to this are contraceptive treatments for female participants, and those taking "as needed" 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 only use 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 a learning/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 have recently quit smoking or using replacements you must have stopped using them altogether for a period of 3 months before participating in this study)
• • Have excessive caffeine intake (\>500 mg per day). Note: This will be calculated at screening 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 4 weeks . (Note: participation is possible following a 4 week wash out prior to participating and for the duration of the study on the proviso that the supplements they are taking are out of choice and not medically prescribed or advised. Please discuss with the researcher if unsure. NOTE: we would never advise stopping supplements prescribed by your doctor e.g. iron, calcium etc, only those out of choice).
• • 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, or have 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 per month)
• • 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 3 months.
• • Are unable to meet the minimum requirement scores on the cognitive tasks.
• • Experienced an event (professional or personal) that is likely to have impacted your emotional and/or psychological state within the last 8-10 weeks (for example but not restricted 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 your emotional, 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