Dietary InterventionNCT07031076
Investigating the Cognitive and Brain Health Benefits of Lean Pork Consumption
A study testing Ready-to-eat lean pork in frozen, 5-oz packages in people with Dietary Intervention and Dietary Proteins, run by University of Nebraska Lincoln at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if eating more lean pork will lead to better cognition and a healthier brain in older adults. The main questions it aims to answer are: Does eating more lean pork lead to higher scores on cognitive tests and better quality of life? Does eating more lean pork lead to slower… Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Intervention, Dietary Proteins, Dietary Assessment
- What is being tested?
- Ready-to-eat lean pork in frozen, 5-oz packages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2025to Dec 2026
- 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 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Males and females; Age 65-75
- Willingness to adhere to the ready-to-eat lean pork intervention regimen or the control condition regimen (depending on group assignment)
- Score between 51 and 80 out of 100 on the Healthy Eating Index
- Consume less than or equal to 15 grams of lean pork per day on average prior to participating in the study
Show all 15Show fewer
- BMI between 18.5 and 39.9
- Mini-Mental State Examination score 26 or greater
- Vision scored greater than 20/50
- No history of subjective cognitive impairment
- No evidence of loss of instrumental activities of daily living
- Minimal dependence in hygiene, bathing, and dressing
- Low pork consumers
- Willing to discontinue dietary supplement use throughout the duration of the study, if they are consuming supplement at the time of the registration
- No known contraindication to MRI scans as determined by the MRI screening survey questions
Who cannot join
- Current use of medications that may affect their responses to dietary intervention, such as amphetamines, antidepressants, anti-diabetic medications, laxatives, antibiotics, statins and diuretics.
- Known intolerance or allergy to pork
- Current use of nicotine products, including vaping
- Previous use of nicotine products, including vaping, within the recent 6 months at the time of pre-screening
- Diagnosis of mild cognitive impairment
- Diagnosis of any dementia, including, but not limited to, Alzheimer's Disease, Lewy body disease, vascular cognitive impairment and frontotemporal dementia
Show all 16Show fewer
- Diagnosis of psychiatric illness within the last 3 years
- Stroke in previous 12 months
- Cancer diagnosis within past 3 years, except prostate cancer or basal cell carcinoma
- Current chemotherapy or radiation treatment
- Planned move from study area
- Scheduling conflicts that would preclude participation in study activities
- Prior or ongoing involvement in cognitive training or dietary intervention studies
- Contraindications for MRI
- Dietary quality outside the average range (i.e., HEI score less than 51 or greater than 80)
- Other inability to complete study activities
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska-Lincoln
Lincoln, Nebraska, 68588
About this study
The goal of this clinical trial is to learn if eating more lean pork will lead to better cognition and a healthier brain in older adults. The main questions it aims to answer are:
- Does eating more lean pork lead to higher scores on cognitive tests and better quality of life?
- Does eating more lean pork lead to slower brain aging and/or better brain function?
Read more
Researchers will compare participants in the experimental group (participants undergoing the dietary intervention) to control participants (participants that do not undergo the intervention).
Participants will:
- Be instructed to prepare and consume ready-to-eat pork meals along with their regular diet and not eat any more pork other than what they are given; or be instructed to consume their regular diet
- Visit the study facilities once every week to pick up ready-to-eat pork meals and complete dietary surveys; or complete dietary surveys every 4 weeks
- Visit the study facilities before and after the 16-week of intervention period for researchers to study them
Read the detailed description
The goal of this study is to evaluate the effects of learn pork consumption on cognitive and brain health in healthy older adults. Specifically, we seek to evaluate the effects of lean pork consumption on measures of executive function, memory, psychological well-being, and sleep quality. Additionally, we will explore the effects of increased lean pork consumption on measures of brain health derived from structural and functional brain imaging.
The study will consist of two groups of participants: experimental and control. Participants in the experimental group will take part in a 16-week dietary intervention. Throughout the intervention, participants in the experimental group will receive 4 portions of ready-to-eat lean pork in frozen packages each week. Each serving of ready-to-eat lean pork for the experimental group will weigh 5-ounces. Participants in the control group will be asked to continue their regular diet, without receiving any frozen packages of ready-to-eat lean pork. Study compliance will be evaluated through weekly surveys about lean pork consumption.
In addition, all participants will complete pre- and post-intervention assessments:
- MRI scan, including structural and functional brain imaging
- a comprehensive questionnaire battery evaluating cognitive and psychological measures
- neuropsychological tasks
- a blood draw
- Conditions
- Dietary Intervention, Dietary Proteins, Dietary Assessment, Older Adults (65 Years and Older), Cognitive Ability, General
- Being tested
- Ready-to-eat lean pork in frozen, 5-oz packages
- Keywords
- pork consumption, pork dietary intervention, brain health, cognitive health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready-to-eat lean pork in frozen, 5-oz packagesDietary supplement
The dietary intervention lasts 16 weeks for each individual. Participants in the experimental group will receive this intervention. Each participant will acquire 4 portions of ready-to eat lean pork in frozen packages per week; each portion of ready-to-eat lean pork in this intervention will weigh 5 ounces.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group will participate in the 16-week lean pork dietary intervention study. Participants will be provided with 4 portions of ready-to-eat lean pork in frozen packages per week. Each portion of ready-to-eat lean pork provided to this group will weigh 5 ounces. Receives: Dietary Supplement: Ready-to-eat lean pork in frozen, 5-oz packages |
| Control Group | No intervention | The control group will not participate in any dietary intervention, other than being instructed to maintain their regular diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
WAIS-V
Wechsler Adult Intelligence Scale, verison 5. Comprehensive assessment battery for measuring cognitive abilities
Measured: Baseline and after 16 weeks
Trail Making Test
Delis-Kaplan Executive Function System test for sequencing and cognitive flexibility
Measured: Baseline and after 16 weeks
NIH Toolbox (Dimensional Change Card Sort)
Test for executive function and cognitive flexibility
Measured: Baseline and after 16 weeks
NIH Toolbox (Flanker)
test for executive functions: attention and inhibitory control
Measured: Baseline and after 16 weeks
NIH Toolbox (List Sorting Working Memory Test)
Test for working memory
Measured: Baseline and after 16 weeks
Adult Decision-Making Competence test
Assessment of how well adults make decisions. Subcategories include Resistance to Framing, Recognizing Social Norms, Under/Overconfidence, Applying Decision Rules, Consistency in Risk Perception, and Resistance to Sunk Costs
Measured: Baseline and after 16 weeks
Cognitive Reflection Test
Test to measure the ability to suppress an intuitive wrong answer in favor of a more reflective correct answer
Measured: Baseline and after 16 weeks
Attentional Network Task
Computerized task to measure the effects of visual and auditory cues on visual processing
Measured: Baseline and after 16 weeks
UCLA Loneliness Scale
measure of subjective loneliness and social isolation
Measured: Baseline and after 16 weeks
Short Form-36 Health Survey
self-report measure of health status and quality of life
Measured: Baseline and after 16 weeks
Psychological Wellbeing Scale
the psychological wellbeing scale assesses six aspects of psychological wellbeing and happiness: Autonomy, Environmental Mastery, Personal Growth, Positive Relations with Others, Purpose in Life, Self-Acceptance
Measured: Baseline and after 16 weeks
Decision Outcome Inventory
an assessment of outcomes of real-life decisions
Measured: Baseline and after 16 weeks
The Mindset Survey
an assessment to determine whether an individual has a fixed mindset or a growth mindset
Measured: Baseline and after 16 weeks
Need for Cognition Scale
assessment of an individual's tendency to engage in and enjoy thinking or mental exertion
Measured: Baseline and after 16 weeks
Pittsburgh Sleep Quality Index
Self-report assessment of sleep quality over the past month. The survey includes measures related to Sleep Latency, Sleep Duration, Sleep Efficiency, Sleep Disturbances, Use of Sleep Medications, Daytime Fatigue, and Sleep Quality
Measured: Baseline and after 16 weeks
Consortium to Establish a Registry for Alzhiemer's Disease Word List Acquisition and Delayed Recall
A learning and delay memory recall task that is used to quickly assess an individual's mental capacity in memory.
Measured: Baseline and after 16 weeks
Geriatric Depression Scale
Assessment of an older adult's status of mental health that screens for depression
Measured: Baseline and after 16 weeks
Ohio State Traumatic Brain Injury Identification
Interview-style assessment of past head injuries, including their severity and their resulting symptoms.
Measured: Baseline and after 16 weeks
Symptom Checklist 90-Revised
self-report assessment of psychological symptoms related to the domains of somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism
Measured: Baseline and after 16 weeks
Grit
self-report measure of perseverance
Measured: Baseline and after 16 weeks
Brief Dispositional Resilience Scale
a 15-item measure of psychological hardiness, covering aspects related to commitment, control, and challenge
Measured: Baseline and after 16 weeks
Valence Bias Task
an assessment to measure an individual's tendency to interpret ambiguous stimuli as having a positive or negative valence
Measured: Baseline and after 16 weeks
Secondary outcomes (1)
Brain Imaging
- T1- and T2-weighted imaging to visualize the structure of the brain
- Functional MRI of the whole brain to examine changes in brain activity and functional topology
- Diffusion tensor imaging to map the white matter structures in the brain
- Magnetic resonance elastography to examine the elasticity of brain tissues
- Susceptibility weighted imaging to examine cerebrovascular health
Measured: Baseline and after 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study startAug 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: The investigative team has transferred to another university.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dietary InterventionStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska Lincoln
- Sponsor type
- University, hospital or other
- Collaborators
- National Pork Board
- Responsible party
- Sponsor
- Investigators
- Aron Barbey, PhD, Principal investigator, University of Nebraska Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031076
- Sponsor's protocol ID
- 23280
- Status last verified
- Dec 2025
- First submitted
- 12 Jun 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study findings will be submitted to peer-reviewed journals such as those that follow the ICMJE's recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals. The data collected during this project may be shared through public-use files, repositories or other means outside of the approved research team as a requirement of publication. All data will be identified with subject IDs only when shared. Research records such as informed consent forms, MRI Safety Screening forms, research compliance records, masterlist linking names to subject IDs will not be shared.
Publications
Wade AT, Davis CR, Dyer KA, Hodgson JM, Woodman RJ, Keage HAD, Murphy KJ. A Mediterranean Diet with Fresh, Lean Pork Improves Processing Speed and Mood: Cognitive Findings from the MedPork Randomised Controlled Trial. Nutrients. 2019 Jul 4;11(7):1521. doi: 10.3390/nu11071521.
PubMed 31277446Hepsomali P, Groeger JA. Diet and general cognitive ability in the UK Biobank dataset. Sci Rep. 2021 Jun 3;11(1):11786. doi: 10.1038/s41598-021-91259-3.
PubMed 34083695Zhang H, Hardie L, Bawajeeh AO, Cade J. Meat Consumption, Cognitive Function and Disorders: A Systematic Review with Narrative Synthesis and Meta-Analysis. Nutrients. 2020 May 24;12(5):1528. doi: 10.3390/nu12051528.
PubMed 32456281
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Cognitive and Brain Health Benefits of Lean Pork Consumption
- ClinicalTrials.gov ID
- NCT07031076
- Acronym / sponsor ID
- 23280
- Conditions
- Dietary Intervention, Dietary Proteins, Dietary Assessment, Older Adults (65 Years and Older), Cognitive Ability, General
- Keywords
- pork consumption, pork dietary intervention, brain health, cognitive health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The investigative team has transferred to another university.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Nebraska LincolnUniversity, hospital or other
- Collaborators
- National Pork Board
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jun 2025 (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.
The goal of this clinical trial is to learn if eating more lean pork will lead to better cognition and a healthier brain in older adults. The main questions it aims to answer are:
- Does eating more lean pork lead to higher scores on cognitive tests and better quality of life?
- Does eating more lean pork lead to slower brain aging and/or better brain function?
Researchers will compare participants in the experimental group (participants undergoing the dietary intervention) to control participants (participants that do not undergo the intervention).
Participants will:
- Be instructed to prepare and consume ready-to-eat pork meals along with their regular diet and not eat any more pork other than what they are given; or be instructed to consume their regular diet
- Visit the study facilities once every week to pick up ready-to-eat pork meals and complete dietary surveys; or complete dietary surveys every 4 weeks
- Visit the study facilities before and after the 16-week of intervention period for researchers to study them
Detailed description
The goal of this study is to evaluate the effects of learn pork consumption on cognitive and brain health in healthy older adults. Specifically, we seek to evaluate the effects of lean pork consumption on measures of executive function, memory, psychological well-being, and sleep quality. Additionally, we will explore the effects of increased lean pork consumption on measures of brain health derived from structural and functional brain imaging.
The study will consist of two groups of participants: experimental and control. Participants in the experimental group will take part in a 16-week dietary intervention. Throughout the intervention, participants in the experimental group will receive 4 portions of ready-to-eat lean pork in frozen packages each week. Each serving of ready-to-eat lean pork for the experimental group will weigh 5-ounces. Participants in the control group will be asked to continue their regular diet, without receiving any frozen packages of ready-to-eat lean pork. Study compliance will be evaluated through weekly surveys about lean pork consumption.
In addition, all participants will complete pre- and post-intervention assessments:
- MRI scan, including structural and functional brain imaging
- a comprehensive questionnaire battery evaluating cognitive and psychological measures
- neuropsychological tasks
- a blood draw
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Dietary Supplement: Ready-to-eat lean pork in frozen, 5-oz packagesThe experimental group will participate in the 16-week lean pork dietary intervention study. Participants will be provided with 4 portions of ready-to-eat lean pork in frozen packages per week. Each portion of ready-to-eat lean pork provided to this group will weigh 5 ounces. |
| Control Group | No intervention | –The control group will not participate in any dietary intervention, other than being instructed to maintain their regular diet. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Males and females; Age 65-75
- Willingness to adhere to the ready-to-eat lean pork intervention regimen or the control condition regimen (depending on group assignment)
- Score between 51 and 80 out of 100 on the Healthy Eating Index
Key exclusion criteria (16 listed)
- Current use of medications that may affect their responses to dietary intervention, such as amphetamines, antidepressants, anti-diabetic medications, laxatives, antibiotics, statins and diuretics.
- Known intolerance or allergy to pork
- Current use of nicotine products, including vaping
- Previous use of nicotine products, including vaping, within the recent 6 months at the time of pre-screening
- Diagnosis of mild cognitive impairment
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 |
|---|---|---|
| Ready-to-eat lean pork in frozen, 5-oz packagesThe dietary intervention lasts 16 weeks for each individual. Participants in the experimental group will receive this intervention. Each participant will acquire 4 portions of ready-to eat lean pork in frozen packages per week; each portion of ready-to-eat lean pork in this intervention will weigh 5 ounces. | Dietary supplement | Experimental Group |
Primary outcome
WAIS-V
Time frame: Baseline and after 16 weeks
Wechsler Adult Intelligence Scale, verison 5. Comprehensive assessment battery for measuring cognitive abilities
Trail Making Test
Time frame: Baseline and after 16 weeks
Delis-Kaplan Executive Function System test for sequencing and cognitive flexibility
NIH Toolbox (Dimensional Change Card Sort)
Time frame: Baseline and after 16 weeks
Test for executive function and cognitive flexibility
NIH Toolbox (Flanker)
Time frame: Baseline and after 16 weeks
test for executive functions: attention and inhibitory control
NIH Toolbox (List Sorting Working Memory Test)
Time frame: Baseline and after 16 weeks
Test for working memory
Adult Decision-Making Competence test
Time frame: Baseline and after 16 weeks
Assessment of how well adults make decisions. Subcategories include Resistance to Framing, Recognizing Social Norms, Under/Overconfidence, Applying Decision Rules, Consistency in Risk Perception, and Resistance to Sunk Costs
Cognitive Reflection Test
Time frame: Baseline and after 16 weeks
Test to measure the ability to suppress an intuitive wrong answer in favor of a more reflective correct answer
Attentional Network Task
Time frame: Baseline and after 16 weeks
Computerized task to measure the effects of visual and auditory cues on visual processing
UCLA Loneliness Scale
Time frame: Baseline and after 16 weeks
measure of subjective loneliness and social isolation
Short Form-36 Health Survey
Time frame: Baseline and after 16 weeks
self-report measure of health status and quality of life
Psychological Wellbeing Scale
Time frame: Baseline and after 16 weeks
the psychological wellbeing scale assesses six aspects of psychological wellbeing and happiness: Autonomy, Environmental Mastery, Personal Growth, Positive Relations with Others, Purpose in Life, Self-Acceptance
Decision Outcome Inventory
Time frame: Baseline and after 16 weeks
an assessment of outcomes of real-life decisions
The Mindset Survey
Time frame: Baseline and after 16 weeks
an assessment to determine whether an individual has a fixed mindset or a growth mindset
Need for Cognition Scale
Time frame: Baseline and after 16 weeks
assessment of an individual's tendency to engage in and enjoy thinking or mental exertion
Pittsburgh Sleep Quality Index
Time frame: Baseline and after 16 weeks
Self-report assessment of sleep quality over the past month. The survey includes measures related to Sleep Latency, Sleep Duration, Sleep Efficiency, Sleep Disturbances, Use of Sleep Medications, Daytime Fatigue, and Sleep Quality
Consortium to Establish a Registry for Alzhiemer's Disease Word List Acquisition and Delayed Recall
Time frame: Baseline and after 16 weeks
A learning and delay memory recall task that is used to quickly assess an individual's mental capacity in memory.
Geriatric Depression Scale
Time frame: Baseline and after 16 weeks
Assessment of an older adult's status of mental health that screens for depression
Ohio State Traumatic Brain Injury Identification
Time frame: Baseline and after 16 weeks
Interview-style assessment of past head injuries, including their severity and their resulting symptoms.
Symptom Checklist 90-Revised
Time frame: Baseline and after 16 weeks
self-report assessment of psychological symptoms related to the domains of somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism
Grit
Time frame: Baseline and after 16 weeks
self-report measure of perseverance
Brief Dispositional Resilience Scale
Time frame: Baseline and after 16 weeks
a 15-item measure of psychological hardiness, covering aspects related to commitment, control, and challenge
Valence Bias Task
Time frame: Baseline and after 16 weeks
an assessment to measure an individual's tendency to interpret ambiguous stimuli as having a positive or negative valence
1 secondary outcome
Brain Imaging
Time frame: Baseline and after 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Background: PubMed 31277446Wade AT, Davis CR, Dyer KA, Hodgson JM, Woodman RJ, Keage HAD, Murphy KJ. A Mediterranean Diet with Fresh, Lean Pork Improves Processing Speed and Mood: Cognitive Findings from the MedPork Randomised Controlled Trial. Nutrients. 2019 Jul 4;11(7):1521. doi: 10.3390/nu11071521.
- Background: PubMed 34083695Hepsomali P, Groeger JA. Diet and general cognitive ability in the UK Biobank dataset. Sci Rep. 2021 Jun 3;11(1):11786. doi: 10.1038/s41598-021-91259-3.
- Background: PubMed 32456281Zhang H, Hardie L, Bawajeeh AO, Cade J. Meat Consumption, Cognitive Function and Disorders: A Systematic Review with Narrative Synthesis and Meta-Analysis. Nutrients. 2020 May 24;12(5):1528. doi: 10.3390/nu12051528.
- Individual participant dataSharing planned: Yes. Study findings will be submitted to peer-reviewed journals such as those that follow the ICMJE's recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals. The data collected during this project may be shared through public-use files, repositories or other means outside of the approved research team as a requirement of publication. All data will be identified with subject IDs only when shared. Research records such as informed consent forms, MRI Safety Screening forms, research compliance records, masterlist linking names to subject IDs will not be shared.
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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.
Aron Barbey, PhD principal investigator
University of Nebraska Lincoln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ready-to-eat lean pork in frozen, 5-oz packages in people with Dietary Intervention and Dietary Proteins, run by University of Nebraska Lincoln 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 15 inclusion and 16 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: withdrawn, as of the sponsor's last update on 26 Dec 2025. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
WAIS-V (time frame: Baseline and after 16 weeks). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07031076, which also lists 3 linked publications.
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 Dec 2025.