Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06109922
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2023-10-25
Brief Title:
Investigating the Effects of Dietary Phospholipids on Stress Reactivity and Recovery
Sponsor:
Northumbria University
Organization:
Northumbria University
Study Overview
Official Title:
Investigating the Effects of Dietary Phospholipids on Stress Reactivity and Recovery
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to investigate the effects of 6- and 12- week supplementation of a bioactive whey protein concentrate drink containing dairy phospholipids on stress reactivity and recovery in healthy adults
The proposed randomised double-blind placebo-controlled parallel groups design methodology will assess the stress reactivity and recovery effects both self-reported and physiological of 40g per day of bioactive whey protein concentrate in the form of a powder that the participant will be required to mix with 350ml of water and matched placebo prior to baseline and after -6 week and -12 week supplementation The trial will utilise the Multi-tasking framework MTF during testing visits to elicit an acute stress response within the laboratory Self reported anxiety STAI short-form at multiple time points before and after the stressor will be measured as well as perceived task demand following the stressor NASA-TLX
Physiological measurements of the stress response will also be measured through blood pressure heart rate arability and galvanic skin response
150 participants will participate aged 25-49 and self-reported as being in good health Participants will be supplied with either the active treatment or the placebo allocated by a randomised schedule whilst visiting the research centre for the testing appointments and will take treatment home to consume daily for the duration of the study Participants will record time of taking treatment each day in a treatment diary which will be returned to the research centre along with any unused treatment upon completion of the study
The proposed randomised double-blind placebo-controlled parallel groups design methodology will assess the stress reactivity and recovery effects both self-reported and physiological of 40g per day of bioactive whey protein concentrate in the form of a powder that the participant will be required to mix with 350ml of water and matched placebo prior to baseline and after -6 week and -12 week supplementation The trial will utilise the Multi-tasking framework MTF during testing visits to elicit an acute stress response within the laboratory Self reported anxiety STAI short-form at multiple time points before and after the stressor will be measured as well as perceived task demand following the stressor NASA-TLX
Physiological measurements of the stress response will also be measured through blood pressure heart rate arability and galvanic skin response
150 participants will participate aged 25-49 and self-reported as being in good health Participants will be supplied with either the active treatment or the placebo allocated by a randomised schedule whilst visiting the research centre for the testing appointments and will take treatment home to consume daily for the duration of the study Participants will record time of taking treatment each day in a treatment diary which will be returned to the research centre along with any unused treatment upon completion of the study
Detailed Description:
The study will follow a randomised placebo-controlled double-blind parallel groups design Participants will be given 12-weeks worth of either placebo or active treatment to be consumed at home each day double blinded will attend all 5 appointments required will complete the at home treatment diary daily as well as participate in the multi-tasking stress tasks on each of the 3 testing visits
Participants will attend the research centre on four separate occasions which will include a screeningtraining visit pre intervention testing visit a mid-point testing visit at 6 weeks and a completion of intervention testing visit at 12 weeks 5 Appointments in total including the online appointment to check for eligibility The remote screening session will be completed via telephone call and will comprise briefing on the requirements for the study answering any initial questions obtaining of informed consent via completion of an online consent form health screening collection of demographic information and completion of the Caffeine Consumption Questionnaire CCQ
The introductorytraining visit to the laboratory will begin with physiological eligibility measures that cannot be completed remotely eg blood pressure height and weight waist-to-hip ratio followed by training on the cognitive and mood measures
The study will include 150 healthy participants aged between 25-49 years who will receive 12 weeks worth of either 40g per day of bioactive whey protein concentrate powder containing dairy phospholipids to be mixed with 350ml of water to form a drink or a similar of placebo powder Participants will be randomly allocated to either the treatment or placebo group and neither the participant nor the researcher will know which group they have been allocated to Full instructions of how and when to take treatment each day will be explained to the participants when treatment is given at testing visit 1
On each of the three study days Day 1 42 and 84 participants will attend the research centre having abstained from alcohol for 24 hours and caffeine overnight following a standardised breakfast of cereal andor toast at home no later than 1 hour prior to arrival After completing the cognition tasks outlined in a separate protocol the participants will be taken one by one to a separate room accompanied by the lead researcher to participate in the stress reactivity and recovery task The task is the Multi-Tasking Framework MTF and will last approx 20 minutes During this time participants will be required to remain concentrated on 4 tasks simultaneously to achieve the highest overall score possible The tasks are a mixture of difficulty and require different skills such as reaction time memory and attention Whilst the participants are completing the tasks the researcher will be monitoring their performance and providing feedback and instruction Blood pressure will be taken before and after the task Questionnaires to measure state anxiety and perceived task demand will be taken at different time points surrounding the stressor Participants will also be required to wear a heart rate monitor and sensors on their fingertips to measure heart rate variability and galvanic skin response in response to the stressor
Participants will additionally complete a treatment guess form at their final visit and will be fully debriefed
Participants will attend the research centre on four separate occasions which will include a screeningtraining visit pre intervention testing visit a mid-point testing visit at 6 weeks and a completion of intervention testing visit at 12 weeks 5 Appointments in total including the online appointment to check for eligibility The remote screening session will be completed via telephone call and will comprise briefing on the requirements for the study answering any initial questions obtaining of informed consent via completion of an online consent form health screening collection of demographic information and completion of the Caffeine Consumption Questionnaire CCQ
The introductorytraining visit to the laboratory will begin with physiological eligibility measures that cannot be completed remotely eg blood pressure height and weight waist-to-hip ratio followed by training on the cognitive and mood measures
The study will include 150 healthy participants aged between 25-49 years who will receive 12 weeks worth of either 40g per day of bioactive whey protein concentrate powder containing dairy phospholipids to be mixed with 350ml of water to form a drink or a similar of placebo powder Participants will be randomly allocated to either the treatment or placebo group and neither the participant nor the researcher will know which group they have been allocated to Full instructions of how and when to take treatment each day will be explained to the participants when treatment is given at testing visit 1
On each of the three study days Day 1 42 and 84 participants will attend the research centre having abstained from alcohol for 24 hours and caffeine overnight following a standardised breakfast of cereal andor toast at home no later than 1 hour prior to arrival After completing the cognition tasks outlined in a separate protocol the participants will be taken one by one to a separate room accompanied by the lead researcher to participate in the stress reactivity and recovery task The task is the Multi-Tasking Framework MTF and will last approx 20 minutes During this time participants will be required to remain concentrated on 4 tasks simultaneously to achieve the highest overall score possible The tasks are a mixture of difficulty and require different skills such as reaction time memory and attention Whilst the participants are completing the tasks the researcher will be monitoring their performance and providing feedback and instruction Blood pressure will be taken before and after the task Questionnaires to measure state anxiety and perceived task demand will be taken at different time points surrounding the stressor Participants will also be required to wear a heart rate monitor and sensors on their fingertips to measure heart rate variability and galvanic skin response in response to the stressor
Participants will additionally complete a treatment guess form at their final visit and will be fully debriefed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None