HealthyCBD-FocusNCT05189275
Cannabidiol and Focus Study (CBD-Focus)
A study testing Daily Beverage Intervention in people with Healthy, run by University of Northern Colorado at 1 site in United States.
Trial summary
Cannabidiol (CBD), a non-psychoactive hemp derivative, is an attractive therapeutic target, and is most supported by the scientific community as an antiepileptic, anxiolytic, and antipsychotic. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Daily Beverage Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2022to 31 Dec 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Currently completing at least 150 minutes of moderate to vigorous physical activity per week
- Have a body mass index under 29.9
- No significant physical or mental health (without the presence of chronic depression or anxiety) conditions
- No presence or past diagnosis of eating disorders
Who cannot join
- Subjects may not have an allergy to soy.
- All study subjects must also be free of cannabis product use or regular high doses of antioxidants for the previous 8 weeks.
- Participants receive a $200 Visa Gift Card after the last study visit is completed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Northern Colorado
Greeley, Colorado, 80639
About this study
Cannabidiol (CBD), a non-psychoactive hemp derivative, is an attractive therapeutic target, and is most supported by the scientific community as an antiepileptic, anxiolytic, and antipsychotic. Additionally, CBD may cause alterations in aspects of health and fitness, fatigue, stress, calmness, quality of life, cognitive function, ability to maintain focus, sleep quantity, and sleep quality. Cannabidiol may be associated with alterations in inflammatory response in the human body, which has implications in both healthy and diseased populations. Natural killers cells (NKC) play a vital role in maintain your body's defenses and are an essential component of your immune system. In humans, NKC contain the highest concentrations of receptors associated with the endocannabinoid system and CBD. Human models have demonstrated that CBD use increases the percentage of NKC in peripheral blood. However, similar models found that CBD administration inhibits markers of NKC cytotoxic function, a beneficial cellular mechanism used to prevent malignant cell transformation and viral infection. The overarching goal of this investigation is to determine the effects of an 8-week CBD intervention on measures of fatigue, stress, calmness, quality of life, cognitive function, focus, health and fitness, and sleep quantity, and sleep quality. In addition, this study will explore a potential CBD mechanism of action with a focus on biomarkers of neural health, inflammation, liver health, kidney health, as well as NKC number and function.
Read the detailed description
BACKGROUND: Cannabidiol (CBD), a non-psychoactive hemp derivative, is an attractive therapeutic target, and is most supported by the scientific community as an antiepileptic, anxiolytic, and antipsychotic. Additionally, CBD may cause alterations in aspects of health and fitness, fatigue, stress, calmness, quality of life, cognitive function, ability to maintain focus, sleep quantity, and sleep quality. Cannabidiol may be associated with alterations in inflammatory response in the human body, which has implications in both healthy and diseased populations. In humans, natural killer cells (NKC) contain the highest concentrations of receptors associated with the endocannabinoid system and CBD. Human models have demonstrated that CBD use increases the percentage of NKC in peripheral blood. However, similar models found that CBD administration inhibits markers of NKC cytotoxic function, a beneficial cellular mechanism used to prevent malignant cell transformation and viral infection. The overarching goal of this investigation is to determine the effects of an 8-week CBD intervention on measures of fatigue, stress, calmness, quality of life, cognitive function, focus, health and fitness, and sleep quantity, and sleep quality. In addition, this study will explore a potential CBD mechanism of action with a focus on biomarkers of neural health, inflammation, liver health, kidney health, as well as NKC number and function.
METHODS: In this double-blind, placebo-controlled, 4 arm clinical trial, male and female participants will undergo 2 pre intervention study visits and 3 post intervention study visits separated by an 8-week intervention period. Participants must be aged 18-50 years old, currently completing at least 150 minutes of moderate to vigorous physical activity per week, have a body mass index under 29.9, with no significant physical or mental health (without the presence of chronic depression or anxiety) conditions. Subjects may not have an allergy to soy. All study subjects must also be free of cannabis product use or regular high doses of antioxidants for the previous 8 weeks. Supplementation groups will be randomly assigned into groups consuming one of 4 beverages: 1) a beverage with 40 mg of CBD (CBD40, n=50), 2) a beverage with 20 mg of CBD (CBD20, n=50), 3) a beverage with 0 mg of CBD (CBD0, n=50) or 4) calorie-matched placebo (PLAC, n=50).
INTERVENTION DESCRIPTION: Participants will be instructed to consume one beverage per day following their last meal, 1-1.5h before bed. Four weeks of beverages will be provided at a time. These beverage deposits will include an in person check in at the midpoint of the study. Participants and researchers will be blinded to the intervention groups. All participants will be given a 4-week supply of beverages. Investigators will meet with participants weekly via zoom/phone call and to report any adverse side effects or changes in physical activity routine. All products will be provided by Ocean Spray. All products are hemp derived, within legal limits and have had their purity verified. Following the completion of data collection for all study participants, researchers will be unblinded to supplementation groups.
- Conditions
- Healthy
- Being tested
- Daily Beverage Intervention
- Keywords
- Cannabidiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Beverage InterventionDietary supplement
Individuals will consume one of 4 beverages, daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol 40 mg (CBD40) | Experimental | Subjects consume beverages with 40mg of CBD. Receives: Dietary Supplement: Daily Beverage Intervention |
| Cannabidiol 20 mg (CBD20) | Experimental | Subjects consume beverages with 20mg of CBD. Receives: Dietary Supplement: Daily Beverage Intervention |
| Cannabidiol 0 mg (CBD0) | Experimental | Subjects consume beverages with 0mg of CBD. Receives: Dietary Supplement: Daily Beverage Intervention |
| Placebo Beverage (PLAC) | Placebo comparator | Subjects consume calorie matched beverages with 0 CBD. Receives: Dietary Supplement: Daily Beverage Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life Questionnaire Score
Ferrans and Powers Quality of Life Index Questionnaire. A higher scores suggests higher quality of life.
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Change in Fatigue Score
Piper Fatigue Questionnaire. A higher score suggests higher levels of fatigue.
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Change in Sleep Assessment
Sleep Assessment (7 day). We will use Fitbits to track sleep.
Measured: Just before the 8 Week Intervention and in the 7th Week of the 8 Week Intervention
Change in Sleep Questionnaire Score
Leeds Sleep Questionnaire. Lower scores generally suggest better sleep.
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Change in Physical Activity (steps per day)
Physical Activity Assessment (7 day). We will use Fitbits to track physical activity.
Measured: Just before the 8 Week Intervention and in the 7th Week of the 8 Week Intervention
Change in Perceived Stress Scale Score
Perceived Stress Questionnaire. A higher score suggests higher perceived stress.
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Change in General Anxiety Disorder Questionnaire Score
General Anxiety Disorder Questionnaire 7. A higher score suggests higher levels of anxiety.
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Change in Psychological Wellbeing Scale Score
Psychological Wellbeing Questionnaire. A higher score suggests better wellbeing.
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Change in Cognitive Function and Abilities Score
Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Abilities - Short Form 8a. A higher score suggests higher cognitive ability.
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Change In Cognitive Function Score
PROMIS Cognitive Function - Short Form 8a. A higher score suggests higher cognitive ability.
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Change in Athlete Sickness and Illness Assessment Score
The Wisconsin Upper Respiratory Symptom Survey. A higher scores suggests more respiratory symptoms.
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Change in Sustained Attention to Response Task (SART) Activity
Sustained Attention to Response Task (SART) Activity
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Change in Maximal Anaerobic Power
Wingate Power Test
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Change in Natural Killer (NK) Cell Number
NK Cell Counts obtained on a flow cytometer.
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Change in Natural Killer (NK) Cell Function
NK Cell Cellular Function Assay using Flow Cytometry
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Change in a Biomarker of Inflammation
Serum C-Reactive Protein
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Change in a Biomarker of Neural Health
Circulating Brain Derived Neurotropic Factor
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Change in a Stress Biomarker
Serum Cortisol
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Change in Liver Health Biomarker I
Serum Aspartate aminotransferase (AST)
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Change in Liver Health Biomarker II
Serum Alanine aminotransferase (ALT)
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Change in Kidney Health Biomarker
Serum creatinine
Measured: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start10 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Parallel groups
- Model description
- Study participants will be randomly assigned to 1 of 4 groups and followed throughout the 8 week intervention period.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Northern Colorado
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Stewart, University of Northern Colorado
- Investigators
- James Haughian, PhD, Principal investigator, University of Northern ColoradoLaura K Stewart, PhD, Principal investigator, University of Northern Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189275
- Sponsor's protocol ID
- 28497
- Acronym
- CBD-Focus
- Status last verified
- Sep 2023
- First submitted
- 20 Nov 2021
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will become available when the study is published and will be available for 3 years.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol and Focus Study (CBD-Focus)
- ClinicalTrials.gov ID
- NCT05189275
- Acronym / sponsor ID
- CBD-Focus / 28497
- Conditions
- Healthy
- Keywords
- Cannabidiol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Northern ColoradoUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 Jan 2022 (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.
Cannabidiol (CBD), a non-psychoactive hemp derivative, is an attractive therapeutic target, and is most supported by the scientific community as an antiepileptic, anxiolytic, and antipsychotic. Additionally, CBD may cause alterations in aspects of health and fitness, fatigue, stress, calmness, quality of life, cognitive function, ability to maintain focus, sleep quantity, and sleep quality. Cannabidiol may be associated with alterations in inflammatory response in the human body, which has implications in both healthy and diseased populations. Natural killers cells (NKC) play a vital role in maintain your body's defenses and are an essential component of your immune system. In humans, NKC contain the highest concentrations of receptors associated with the endocannabinoid system and CBD. Human models have demonstrated that CBD use increases the percentage of NKC in peripheral blood. However, similar models found that CBD administration inhibits markers of NKC cytotoxic function, a beneficial cellular mechanism used to prevent malignant cell transformation and viral infection. The overarching goal of this investigation is to determine the effects of an 8-week CBD intervention on measures of fatigue, stress, calmness, quality of life, cognitive function, focus, health and fitness, and sleep quantity, and sleep quality. In addition, this study will explore a potential CBD mechanism of action with a focus on biomarkers of neural health, inflammation, liver health, kidney health, as well as NKC number and function.
Detailed description
BACKGROUND: Cannabidiol (CBD), a non-psychoactive hemp derivative, is an attractive therapeutic target, and is most supported by the scientific community as an antiepileptic, anxiolytic, and antipsychotic. Additionally, CBD may cause alterations in aspects of health and fitness, fatigue, stress, calmness, quality of life, cognitive function, ability to maintain focus, sleep quantity, and sleep quality. Cannabidiol may be associated with alterations in inflammatory response in the human body, which has implications in both healthy and diseased populations. In humans, natural killer cells (NKC) contain the highest concentrations of receptors associated with the endocannabinoid system and CBD. Human models have demonstrated that CBD use increases the percentage of NKC in peripheral blood. However, similar models found that CBD administration inhibits markers of NKC cytotoxic function, a beneficial cellular mechanism used to prevent malignant cell transformation and viral infection. The overarching goal of this investigation is to determine the effects of an 8-week CBD intervention on measures of fatigue, stress, calmness, quality of life, cognitive function, focus, health and fitness, and sleep quantity, and sleep quality. In addition, this study will explore a potential CBD mechanism of action with a focus on biomarkers of neural health, inflammation, liver health, kidney health, as well as NKC number and function.
METHODS: In this double-blind, placebo-controlled, 4 arm clinical trial, male and female participants will undergo 2 pre intervention study visits and 3 post intervention study visits separated by an 8-week intervention period. Participants must be aged 18-50 years old, currently completing at least 150 minutes of moderate to vigorous physical activity per week, have a body mass index under 29.9, with no significant physical or mental health (without the presence of chronic depression or anxiety) conditions. Subjects may not have an allergy to soy. All study subjects must also be free of cannabis product use or regular high doses of antioxidants for the previous 8 weeks. Supplementation groups will be randomly assigned into groups consuming one of 4 beverages: 1) a beverage with 40 mg of CBD (CBD40, n=50), 2) a beverage with 20 mg of CBD (CBD20, n=50), 3) a beverage with 0 mg of CBD (CBD0, n=50) or 4) calorie-matched placebo (PLAC, n=50).
INTERVENTION DESCRIPTION: Participants will be instructed to consume one beverage per day following their last meal, 1-1.5h before bed. Four weeks of beverages will be provided at a time. These beverage deposits will include an in person check in at the midpoint of the study. Participants and researchers will be blinded to the intervention groups. All participants will be given a 4-week supply of beverages. Investigators will meet with participants weekly via zoom/phone call and to report any adverse side effects or changes in physical activity routine. All products will be provided by Ocean Spray. All products are hemp derived, within legal limits and have had their purity verified. Following the completion of data collection for all study participants, researchers will be unblinded to supplementation groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Study participants will be randomly assigned to 1 of 4 groups and followed throughout the 8 week intervention period.
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol 40 mg (CBD40) | Experimental | Dietary Supplement: Daily Beverage InterventionSubjects consume beverages with 40mg of CBD. |
| Cannabidiol 20 mg (CBD20) | Experimental | Dietary Supplement: Daily Beverage InterventionSubjects consume beverages with 20mg of CBD. |
| Cannabidiol 0 mg (CBD0) | Experimental | Dietary Supplement: Daily Beverage InterventionSubjects consume beverages with 0mg of CBD. |
| Placebo Beverage (PLAC) | Placebo comparator | Dietary Supplement: Daily Beverage InterventionSubjects consume calorie matched beverages with 0 CBD. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Currently completing at least 150 minutes of moderate to vigorous physical activity per week
- Have a body mass index under 29.9
- No significant physical or mental health (without the presence of chronic depression or anxiety) conditions
- No presence or past diagnosis of eating disorders
Key exclusion criteria (3 listed)
- Subjects may not have an allergy to soy.
- All study subjects must also be free of cannabis product use or regular high doses of antioxidants for the previous 8 weeks.
- Participants receive a $200 Visa Gift Card after the last study visit is completed.
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 |
|---|---|---|
| Daily Beverage InterventionIndividuals will consume one of 4 beverages, daily for 8 weeks. | Dietary supplement | Cannabidiol 0 mg (CBD0), Cannabidiol 20 mg (CBD20), Cannabidiol 40 mg (CBD40), Placebo Beverage (PLAC) |
Primary outcome
Change in Quality of Life Questionnaire Score
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Ferrans and Powers Quality of Life Index Questionnaire. A higher scores suggests higher quality of life.
Change in Fatigue Score
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Piper Fatigue Questionnaire. A higher score suggests higher levels of fatigue.
Change in Sleep Assessment
Time frame: Just before the 8 Week Intervention and in the 7th Week of the 8 Week Intervention
Sleep Assessment (7 day). We will use Fitbits to track sleep.
Change in Sleep Questionnaire Score
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Leeds Sleep Questionnaire. Lower scores generally suggest better sleep.
Change in Physical Activity (steps per day)
Time frame: Just before the 8 Week Intervention and in the 7th Week of the 8 Week Intervention
Physical Activity Assessment (7 day). We will use Fitbits to track physical activity.
Change in Perceived Stress Scale Score
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Perceived Stress Questionnaire. A higher score suggests higher perceived stress.
Change in General Anxiety Disorder Questionnaire Score
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
General Anxiety Disorder Questionnaire 7. A higher score suggests higher levels of anxiety.
Change in Psychological Wellbeing Scale Score
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Psychological Wellbeing Questionnaire. A higher score suggests better wellbeing.
Change in Cognitive Function and Abilities Score
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Abilities - Short Form 8a. A higher score suggests higher cognitive ability.
Change In Cognitive Function Score
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
PROMIS Cognitive Function - Short Form 8a. A higher score suggests higher cognitive ability.
Change in Athlete Sickness and Illness Assessment Score
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
The Wisconsin Upper Respiratory Symptom Survey. A higher scores suggests more respiratory symptoms.
Change in Sustained Attention to Response Task (SART) Activity
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Sustained Attention to Response Task (SART) Activity
Change in Maximal Anaerobic Power
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Wingate Power Test
Change in Natural Killer (NK) Cell Number
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
NK Cell Counts obtained on a flow cytometer.
Change in Natural Killer (NK) Cell Function
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
NK Cell Cellular Function Assay using Flow Cytometry
Change in a Biomarker of Inflammation
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Serum C-Reactive Protein
Change in a Biomarker of Neural Health
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Circulating Brain Derived Neurotropic Factor
Change in a Stress Biomarker
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Serum Cortisol
Change in Liver Health Biomarker I
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Serum Aspartate aminotransferase (AST)
Change in Liver Health Biomarker II
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Serum Alanine aminotransferase (ALT)
Change in Kidney Health Biomarker
Time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Serum creatinine
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 26 Sep 2023.
- Individual participant dataSharing planned: Yes. Data will become available when the study is published and will be available for 3 years.
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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.
James Haughian, PhD principal investigator
University of Northern Colorado
Laura K Stewart, PhD principal investigator
University of Northern Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Beverage Intervention in people with Healthy, run by University of Northern Colorado at 1 site in United States.
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 3 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 26 Sep 2023. 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 States. 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 Quality of Life Questionnaire Score (time frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention). The study lists 21 primary outcomes in all. 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 26 Sep 2023.