StressNCT07369869
Evaluating the Effects of Nutritional Interventions on Sleep, the Gut Microbiome, Cognition, and Stress.
A study testing Proprietary 'active' composition 1 and Proprietary 'active' composition 2 in people with Stress and Sleep, run by Northumbria University at 1 site in United Kingdom.
Trial summary
This will be a double-blind, placebo-controlled, parallel-group trial. Participants who are poor sleepers will be randomised to receive one of two investigational supplements, or a placebo control supplement, over a 28-day period. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Proprietary 'active' composition 1 and Proprietary 'active' composition 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must self-assess themselves as being in good health.
- Aged 25 to 60 years at the time of randomisation
- Fluent in English
- Identify as a 'poor sleeper' as defined subjectively (i.e. poor sleep quality, unrefreshing sleep) and a total score of >5 on the Pittsburgh Sleep Quality Index (PSQI).
Who cannot join
- Member of own household currently participating in this trial
- Evidence of current or recent sleep disorders (e.g. sleep apnoea, insomnia, circadian rhythm disorders), taking any medication which exerts sedative effects, affects the CNS and/or sleep, or be currently unwell with any illness that affects sleep (i.e. disorders of the CNS). An initial screening for sleep disorders will be conducted using the Sleep Disorders Symptom Checklist-25 (SDS-CL; Klingman et al., 2017). If a participant reports positively to any of the 25 questions in terms of being affected for three nights per week, or more, this will be followed up using a clinical interview according to the International Classification of Sleep Disorders (ICSD-3) to exclude on the basis of a sleep disorder
- History of seizures or epilepsy
- Shift working or have a history of shift work within the previous six months
- Currently, or within the previous 8 weeks, consuming any nutritional supplements.
- Participation in any other intervention research trials
Show all 14Show fewer
- Sleeping at a location other than their usual residence more than two nights per week during participation
- Travel across multiple time zones within the last three months or have planned travel across multiple time zones during the study
- Current or recent mood disturbances or Axis I disorders (descriptions will be given)
- Current misuse of alcohol and/or drugs
- Current smoker
- Recent (within the last 12 weeks) infection and/or use of antibiotic medication
- Pregnant, seeking to become pregnant or lactating
- Those using (including within the last 2 weeks) proton-pump inhibitors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Northumbria University- Northumbria Sleep center and NUTRAN
Newcastle upon Tyne
About this study
Official title: Evaluating the Effects of Nutritional Interventions on Sleep, the Gut Microbiome, Cognition, and Stress Following 28 Days Consumption in Adults Reporting Sub-clinical Sleep Deficits: A Randomised, Double-blind, Placebo-controlled, Three-arm Parallel Groups Trial.
This will be a double-blind, placebo-controlled, parallel-group trial. Participants who are poor sleepers will be randomised to receive one of two investigational supplements, or a placebo control supplement, over a 28-day period. At baseline and following 28 days of consumption, sleep quality, gut microbiome profiles, cognitive performance, and mood will be assessed. Sleep outcome measures will also be assessed throughout the supplementation period to monitor the time course of any observed changes. A final data set of at least 66 participants is expected.
Read the detailed description
This will be a double-blind, placebo-controlled, parallel-group trial. Participants who are poor sleepers will be randomised to receive one of two investigational supplements, or a placebo control supplement, over a 28-day period. At baseline and following 28 days of consumption, sleep quality, gut microbiome profiles, cognitive performance, and mood will be assessed. Sleep outcome measures will also be assessed throughout the supplementation period to monitor the time course of any observed changes. A final data set of at least 66 participants is expected.
Interested participants will initially be scheduled to complete a screening telephone call with the researcher. Here, electronic informed consent will first be provided by the participant, by accessing a pre-emailed link to the Qualtrics survey platform, to an account which is hosted by Northumbria University. Once consent is obtained, the participant will confirm that they do not meet any of the study exclusion criteria, and will complete the SDS-CL checklist with the researcher, over the phone. If any clinical thresholds are met, participants will be invited to a separate clinical interview (again via phonecall) with Professor Jason Ellis, employing the International Classification of Sleep Disorders (ICSD-3) criteria, to determine elligibility.
If participants progress to enrolment, they will be invited to attend a lab-based training/screening session (protocol day -7) at Northumbria University. Here, hard and wet-signed (by both the participant and the researcher) consent forms will be completed and stored on site. Participants will then be familiarised with the study protocol and procedures. Participants will also be trained on the cognitive tasks. During the following 7 nights (Protocol days -7 to -1), participants will monitor their sleep and complete the daily Sleep Diary each morning. During this week, they will also drop off their pre-dose baseline stool sample at a remote drop-off location at Northumbria University.
Seven days following the lab-based screening visit (Supplement day 1, Protocol day 0), participants will attend the laboratory for their acute visit. Here, a pre-dose baseline sample of saliva and a single blood sample will be taken (for Alpha Amylase, Cortisol, Serotonin and Melatonin), and Blood Pressure, Heart Rate, Body Mass Index, and Waist-to-Hip Ratio will be measured. Participants will complete the Intake24 dietary assessment, and gastrointestinal symptoms questionnaires, as well as the Pittsburgh Sleep Quality Index (PSQI), State-Trait Anxiety Inventory (STAI), and Depression, Anxiety and Stress Scale - 21 Items (DASS-21). The cognitive task battery will additionally be completed.
After completing these measures, participants will receive instructions on the next phase of the trial. From that night, participants will consume their first dose of the investigational supplement (noting the time in their treatyment diary) 4 hours before their normal bed-time. They will monitor their sleep overnight. The following morning (supplementation day 2, protocol day 1), participants will complete their Sleep Diary. Participants will follow this procedure for the following 27 days. At some point during Protocol (Days 12-18), participants will return to Northumbria University to drop-off their interim stool sample.
On Protocol day 28, participants will return to the lab for the chronic testing visit. All of the outcome measures assessed during the acute lab visit (Protocol day 0) will be repeated here. At the end of the session, participants will be debriefed, and their participation payment arranged. At some point during Protocol (Days 27-33) participants will return to Northumbria University to drop-off their chronic stool sample.
- Conditions
- Stress, Sleep, Cognition, Nutrition, Microbiome
- Being tested
- Proprietary 'active' composition 1, Proprietary 'active' composition 2, Inactive control supplement
- Keywords
- sleep, gut health, cognition, stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprietary 'active' composition 1Dietary supplement
A proprietary orally administered dietary supplement consisting of standardized ingredients.
Proprietary 'active' composition 2Dietary supplement
A proprietary orally administered dietary supplement consisting of standardized ingredients.
Inactive control supplementDietary supplement
Flavored vehicle
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants will be randomly allocated to consume investigational supplement (1 of 2 proprietary 'active' compositions) for 28 days. Receives: Dietary Supplement: Proprietary 'active' composition 1 |
| Arm 2 | Experimental | Participants will be randomly allocated to consume investigational supplement (1 of 2 proprietary 'active' compositions) for 28 days. Receives: Dietary Supplement: Proprietary 'active' composition 2 |
| Control | Placebo comparator | Participants will be randomly allocated to consume control supplement for 28 days. Receives: Dietary Supplement: Inactive control supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency (SE)
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed.
Measured: Change from Baseline to end of supplementation period at 28 days
Secondary outcomes (14)
Actigraphy - Sleep onset latency
recorded minutes taken from intention to sleep to sleep initiation
Measured: Change from baseline following 28 days of supplement consumption
Actigraphy - Sleep efficiency
ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed (percentage)
Measured: Change from baseline following 28 days of supplement consumption
Actigraphy - Number of awakenings
recorded number of awakenings during entire sleep period
Measured: Change from baseline following 28 days of supplement consumption
Actigraphy - Wake after sleep onset (WASO)
recorded minutes awake during the entire sleep period following sleep onset
Measured: Change from baseline following 28 days of supplement consumption
COMPASS global performance measures
Speed of performance, and accuracy of performance measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University)
Measured: Change from baseline following 28 days of supplement consumption
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI): Total Score. The PSQI is a validated self-rating instrument assessing aspects of sleep quality.Minimum score 0 (better); maximum score 21 (worse) < or = 5 associated with good sleep quality; > 5 associated with poor sleep quality.
Measured: Change from baseline following 28 days of supplement consumption
Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
A 21-item measure of mood over the previous week (each item is rated on scale from 0-3). Scoring creates 3 component scores: depression, anxiety and stress (each on a scale of 0-21) with higher scores indicating higher symptomology. Cut-off scores, according to each set of symptoms, are available (normal, mild, moderate, severe and extremely severe) or total scores can be derived by multiplying the sum of all three component scores by 2.
Measured: Change from baseline following 28 days of supplement consumption
State-Trait Anxiety Inventory (STAI)
A 40-item measure of current and general anxiety levels. Each item is rated on a scale from 1-4. Scoring creates two components: state anxiety (20 items) and trait anxiety (20 items), with a range for each between 20-80. Following transformation through reversed coding, higher scores indicate higher levels of anxiety
Measured: Change from baseline following 28 days of supplement consumption
Actigraphy - Total sleep time
recorded minutes asleep over entire sleep period
Measured: Change from baseline following 28 days of supplement consumption
Sleep Diary - Total sleep time
recorded minutes asleep over entire sleep period
Measured: Change from baseline following 28 days of supplement consumption
Sleep Diary - Sleep onset latency
logged minutes taken from intention to sleep to sleep initiation
Measured: Change from baseline following 28 days of supplement consumption
Sleep Diary - Sleep efficiency
ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed (percentage)
Measured: Change from baseline following 28 days of supplement consumption
Sleep Diary - Number of awakenings
logged number of awakenings during entire sleep period
Measured: Change from baseline following 28 days of supplement consumption
Sleep Diary - Wake after sleep onset (WASO)
logged minutes awake during the entire sleep period following sleep onset
Measured: Change from baseline following 28 days of supplement consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Professor Jason Ellis, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369869
- Sponsor's protocol ID
- 000000
- Status last verified
- Feb 2026
- First submitted
- 19 Jan 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Nutritional Interventions on Sleep, the Gut Microbiome, Cognition, and Stress Following 28 Days Consumption in Adults Reporting Sub-clinical Sleep Deficits: A Randomised, Double-blind, Placebo-controlled, Three-arm Parallel Groups Trial.
- ClinicalTrials.gov ID
- NCT07369869
- Acronym / sponsor ID
- 000000
- Conditions
- Stress, Sleep, Cognition, Nutrition, Microbiome
- Keywords
- sleep, gut health, cognition, stress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Jan 2026 (actual)
- 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.
This will be a double-blind, placebo-controlled, parallel-group trial. Participants who are poor sleepers will be randomised to receive one of two investigational supplements, or a placebo control supplement, over a 28-day period. At baseline and following 28 days of consumption, sleep quality, gut microbiome profiles, cognitive performance, and mood will be assessed. Sleep outcome measures will also be assessed throughout the supplementation period to monitor the time course of any observed changes. A final data set of at least 66 participants is expected.
Detailed description
This will be a double-blind, placebo-controlled, parallel-group trial. Participants who are poor sleepers will be randomised to receive one of two investigational supplements, or a placebo control supplement, over a 28-day period. At baseline and following 28 days of consumption, sleep quality, gut microbiome profiles, cognitive performance, and mood will be assessed. Sleep outcome measures will also be assessed throughout the supplementation period to monitor the time course of any observed changes. A final data set of at least 66 participants is expected.
Interested participants will initially be scheduled to complete a screening telephone call with the researcher. Here, electronic informed consent will first be provided by the participant, by accessing a pre-emailed link to the Qualtrics survey platform, to an account which is hosted by Northumbria University. Once consent is obtained, the participant will confirm that they do not meet any of the study exclusion criteria, and will complete the SDS-CL checklist with the researcher, over the phone. If any clinical thresholds are met, participants will be invited to a separate clinical interview (again via phonecall) with Professor Jason Ellis, employing the International Classification of Sleep Disorders (ICSD-3) criteria, to determine elligibility.
If participants progress to enrolment, they will be invited to attend a lab-based training/screening session (protocol day -7) at Northumbria University. Here, hard and wet-signed (by both the participant and the researcher) consent forms will be completed and stored on site. Participants will then be familiarised with the study protocol and procedures. Participants will also be trained on the cognitive tasks. During the following 7 nights (Protocol days -7 to -1), participants will monitor their sleep and complete the daily Sleep Diary each morning. During this week, they will also drop off their pre-dose baseline stool sample at a remote drop-off location at Northumbria University.
Seven days following the lab-based screening visit (Supplement day 1, Protocol day 0), participants will attend the laboratory for their acute visit. Here, a pre-dose baseline sample of saliva and a single blood sample will be taken (for Alpha Amylase, Cortisol, Serotonin and Melatonin), and Blood Pressure, Heart Rate, Body Mass Index, and Waist-to-Hip Ratio will be measured. Participants will complete the Intake24 dietary assessment, and gastrointestinal symptoms questionnaires, as well as the Pittsburgh Sleep Quality Index (PSQI), State-Trait Anxiety Inventory (STAI), and Depression, Anxiety and Stress Scale - 21 Items (DASS-21). The cognitive task battery will additionally be completed.
After completing these measures, participants will receive instructions on the next phase of the trial. From that night, participants will consume their first dose of the investigational supplement (noting the time in their treatyment diary) 4 hours before their normal bed-time. They will monitor their sleep overnight. The following morning (supplementation day 2, protocol day 1), participants will complete their Sleep Diary. Participants will follow this procedure for the following 27 days. At some point during Protocol (Days 12-18), participants will return to Northumbria University to drop-off their interim stool sample.
On Protocol day 28, participants will return to the lab for the chronic testing visit. All of the outcome measures assessed during the acute lab visit (Protocol day 0) will be repeated here. At the end of the session, participants will be debriefed, and their participation payment arranged. At some point during Protocol (Days 27-33) participants will return to Northumbria University to drop-off their chronic stool sample.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Dietary Supplement: Proprietary 'active' composition 1Participants will be randomly allocated to consume investigational supplement (1 of 2 proprietary 'active' compositions) for 28 days. |
| Arm 2 | Experimental | Dietary Supplement: Proprietary 'active' composition 2Participants will be randomly allocated to consume investigational supplement (1 of 2 proprietary 'active' compositions) for 28 days. |
| Control | Placebo comparator | Dietary Supplement: Inactive control supplementParticipants will be randomly allocated to consume control supplement for 28 days. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must self-assess themselves as being in good health.
- Aged 25 to 60 years at the time of randomisation
- Fluent in English
- Identify as a 'poor sleeper' as defined subjectively (i.e. poor sleep quality, unrefreshing sleep) and a total score of >5 on the Pittsburgh Sleep Quality Index (PSQI).
Key exclusion criteria (14 listed)
- Member of own household currently participating in this trial
- Evidence of current or recent sleep disorders (e.g. sleep apnoea, insomnia, circadian rhythm disorders), taking any medication which exerts sedative effects, affects the CNS and/or sleep, or be currently unwell with any illness that affects sleep (i.e. disorders of the CNS). An initial screening for sleep disorders will be conducted using the Sleep Disorders Symptom Checklist-25 (SDS-CL; Klingman et al., 2017). If a participant reports positively to any of the 25 questions in terms of being affected for three nights per week, or more, this will be followed up using a clinical interview according to the International Classification of Sleep Disorders (ICSD-3) to exclude on the basis of a sleep disorder
- History of seizures or epilepsy
- Shift working or have a history of shift work within the previous six months
- Currently, or within the previous 8 weeks, consuming any nutritional supplements.
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 |
|---|---|---|
| Proprietary 'active' composition 1A proprietary orally administered dietary supplement consisting of standardized ingredients. | Dietary supplement | Arm 1 |
| Proprietary 'active' composition 2A proprietary orally administered dietary supplement consisting of standardized ingredients. | Dietary supplement | Arm 2 |
| Inactive control supplementFlavored vehicle | Dietary supplement | Control |
Primary outcome
Sleep Efficiency (SE)
Time frame: Change from Baseline to end of supplementation period at 28 days
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed.
14 secondary outcomes
Actigraphy - Sleep onset latency
Time frame: Change from baseline following 28 days of supplement consumption
Actigraphy - Sleep efficiency
Time frame: Change from baseline following 28 days of supplement consumption
Actigraphy - Number of awakenings
Time frame: Change from baseline following 28 days of supplement consumption
Actigraphy - Wake after sleep onset (WASO)
Time frame: Change from baseline following 28 days of supplement consumption
COMPASS global performance measures
Time frame: Change from baseline following 28 days of supplement consumption
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline following 28 days of supplement consumption
Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
Time frame: Change from baseline following 28 days of supplement consumption
State-Trait Anxiety Inventory (STAI)
Time frame: Change from baseline following 28 days of supplement consumption
Actigraphy - Total sleep time
Time frame: Change from baseline following 28 days of supplement consumption
Sleep Diary - Total sleep time
Time frame: Change from baseline following 28 days of supplement consumption
Sleep Diary - Sleep onset latency
Time frame: Change from baseline following 28 days of supplement consumption
Sleep Diary - Sleep efficiency
Time frame: Change from baseline following 28 days of supplement consumption
Sleep Diary - Number of awakenings
Time frame: Change from baseline following 28 days of supplement consumption
Sleep Diary - Wake after sleep onset (WASO)
Time frame: Change from baseline following 28 days of supplement consumption
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Professor Jason Ellis, 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 Proprietary 'active' composition 1 and Proprietary 'active' composition 2 in people with Stress and Sleep, run by Northumbria University 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 4 inclusion and 14 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: opening soon, as of the sponsor's last update on 3 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela Alfonso-Miller, MD (+44 01912274149, pam.alfonso-miller@northumbria.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (SE) (time frame: Change from Baseline to end of supplementation period at 28 days). 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 3 Mar 2026.