Cognitive FunctionMinimealNCT06353984
Effects of In-between Meal Products on Cognitive Function in the Elderly
A study testing Minimeal product and Reference product in people with Cognitive Function, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
The overall aim of the present 9-week intervention study is to determine how a healthy drinkable in between meal affects cognitive function and brain activity in healthy adults 70 years and older. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function
- What is being tested?
- Minimeal product and Reference product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSweden
- Study dates
- 26 Aug 2024to 31 Jan 2027
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Signed informed consent prior to any study-related procedure
- Age 70 years and above
- Normal weight to overweight at the screening defined as BMI range 18.5-31.9
- Willing to abstain from regular consumption of medication known to alter gastrointestinal function or inflammatory status after being included and during the study
- Willingness to pick up study products and eat the products according to the instructions each day
Who cannot join
- Diagnosis of type 1 and/or type 2 diabetes
- Immobile (defined as the inability to participate in all study-related procedures)
- History of complicated gastrointestinal surgery
- Diagnosed inflammatory bowel disease (IBD)
- Current diagnosis of psychiatric disease/s or syndromes
- Current diagnosis of neurodegenerative disease
Show all 31Show fewer
- Systemic use of antibiotics and/or steroid medication in the last 4 months prior to inclusion
- Use of probiotics, prebiotics, fermented foods, kombucha, and any other product known to modulate gut microbiota composition in the last 2 months prior to inclusion
- Use of any non-steroidal anti-inflammatory drug (NSAID) more than 3 times a week in the last 2 months prior to inclusion
- Use of statins
- Consumption of any NSAID within 7 days of study start
- Any condition which could interfere with intestinal barrier function (e.g. gluten sensitivity, lactose intolerance, celiac disease, IBS, IBD) as decided by the principal investigators' discretion
- Vegetarian diet
- Allergy to ingredients included in either investigational or reference products
- Regular smoking, use of snuff, nicotine, or e-cigarette use
- Drinking more than 9 standard cups of alcohol per week and/or more than 3 standard cups of alcohol per occasion
- Regular use, for more than three times a week for the last 2 months and/or 7 days prior to inclusion, of medications which according to the principal investigator can have an anti-inflammatory effect or affect in any way the intestinal barrier function or have an impact on the study analysis (such as laxatives, anti-diarrheal, anti-cholinergic, etc.)
- After being included in the study, starting any medication or treatment that could potentially influence the study participation and/or study analysis
- Cerebral bleeding or history of cerebral bleeding
- Claustrophobia
- In operated apparatus (e.g., pacemaker)
- Aneurysm clips or shunts in the head
- Grenade-splinter or metal-splinter in the body (e.g., eyes)
- Metal or electrodes in the body (e.g., temp-catheter, aorta stent, cochlea implant)
- Comprehensive tooth-implants or prosthesis
- Operated in the head or in the heart
- Swallowed a video-capsule
- Left-handed
- Severe vision impairments
- Being highly physically active, competing as a master athlete and/or partaking in physical demanding training more than four times per week, extreme exercising
- Any other reason the investigator feels the subject is not suitable for participation in this aspect of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Nutritionally Balanced In-between Meal Food Product on Cognitive Function in the Elderly - an Explorative Study
The overall aim of the present 9-week intervention study is to determine how a healthy drinkable in between meal affects cognitive function and brain activity in healthy adults 70 years and older. Secondary, the study also investigates the impact of the intervention on low grade inflammation, immune function, gut health, body composition, physical function, and well-being as secondary or exploratory outcomes. The study products have the potential to lower chronic low-grade inflammation in the elderly, improve nutrition and thereby contribute to healthy aging including cognitive function, and the study will also give additional insight regarding secondary and exploratory outcomes.
Read the detailed description
The current study is a nine week three-arm randomized controlled trial that includes a double-blinded, two-armed intervention and a non-blinded comparative arm without any intervention. This study will investigate the effects of a healthy in between meal consisting of processed oats and chickpeas on cognitive function and functional brain activity in healthy older men and women 70 years and older (primary endpoints) and explore the effect of the intervention product on blood markers, body composition, physical activity, physical function, and self-reported well-being in the earlier mentioned population (secondary endpoint). Furthermore, the study will give insight in the preventative value of the intervention product on earlier mentioned age-related conditions as well as adherence to the study product and gives guidance towards further research regarding the effect of food product on age related conditions. Participants will visit the study centre at seven occasions, one time before (pre visit) and six times during the study period to perform one or more tests and/or examinations. The pre visit takes place before the baseline, visit 1 and 2 are at baseline, and visit 3 and 4 are the mid-study-visits in week 3 and 6 of the interventional period. Visit 5 and 6 take place at the last interventional week, ie week 9. Data and sample collection takes place as following:
- visit 0: Eligibility screening and informed consent
- Week 1: visit 1 baseline: Body composition, blood samples, fecal samples, questionnaires and physical activity and function, cognitive function
- Week 1: visit 2 baseline fMRI: Structural MRI, RS-(MRI), N-back task fMRI, word recognition task
- Week 3: visit 3 intermediate visit I: Body composition, blood samples, questionnaires, compliance
- Week 6: visit 4 Intermediate visit I: Body composition, blood samples, questionnaires, compliance
- Week 9: visit 5 study end: same procedure as visit 1
- Week 9. Visit 6 study end: same procedure as visit 2
- Conditions
- Cognitive Function
- Being tested
- Minimeal product, Reference product
- Keywords
- cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimeal productDietary supplement
Intervention product consisting of bioprocessed oats and chickpeas
Reference productDietary supplement
Reference product mimicking available soups and fruit drinks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group receives the study product Receives: Dietary Supplement: Minimeal product |
| Reference group | Active comparator | Reference group receives a reference product Receives: Dietary Supplement: Reference product |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional brain activity
Functional brain activity will be measured by functional magnetic resonance imaging (fMRI)) during the n-back task
Measured: 9 weeks
Secondary outcomes (30)
Fasting blood glucose/insulin
Fasting blood glucose insulin will be taken and the HOMA index (Homeostatic Model Assessment for Insulin Resistance) expressed in mmol/L or mg/dL will be used to assess insulin resistance
Measured: 9 weeks
Blood fats/lipid status
Blood fats/lipid status unit of measurement concentration given mmol/L
Measured: 9 weeks
Interleukin-6
Concentration of interleukin-6 measured in in blood serum corrected for baseline, unit of measurement concentration given as pg/mL
Measured: 9 weeks
High-sensitivity C-reactive protein
High-sensitivity C-reactive protein (HsCRP) measured in blood corrected for baseline, unit of measurement concentration given as mg/L
Measured: 9 weeks
Tumor necrosis factor
Concentration of Tumor necrosis factor (TNF) in blood serum corrected for baseline, unit of measurement concentration given as pg/mL
Measured: 9 weeks
Interferon-gamma
Concentration of Interferon-gamma (IFN-Gamma) in blood serum corrected for baseline, unit of measurement concentration given as pg/mL
Measured: 9 weeks
Zonulin
Zonulin (haptoglobin 2 precursor) is a protein that increases the permeability of tight junctions between cells of the wall of the digestive tract, measured in faeces.
Measured: 9 weeks
Intestinal fatty-acid binding protein
Intestinal fatty-acid binding protein (I-FABP) measured in faeces
Measured: 9 weeks
Cognitive function
Cognitive function will be assessed by an off-line multi-domain cognitive test battery computer-based, word recognition task
Measured: 9 weeks
Magnetic resonance imaging (MRI)
Resting state connectivity functional MRI (rsfMRI) and brain morphology from structural scans (brain and brain stem) are measured by MRI
Measured: 9 weeks
The Perceived Stress Scale
The Perceived Stress Scale (PSS) questionnaire is used to measure the perception of stress in life and has 10 questions with the following options to answer: 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often
Measured: 9 weeks
Hospital Anxiety and Depression Scale
The validated Hospital Anxiety and Depression Scale (HADS) questionnaire will be used to assesses symptoms of depression and anxiety. The HADS has 7 questions related to depressions and 7 questions related to anxiety. A higher total score indicates more depression or anxiety with the following cut off scores: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
Measured: 9 weeks
SF 36
The SF 36 (short form) questionnaire is used to assess general health Status. The SF-36 consists of 36 questions. Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high quality of life
Measured: 9 weeks
Western Ontario and McMaster Osteoarthritis Index
To evaluate hip and knee osteoarthritis Western Ontario and McMaster Osteoarthritis Index (WOMAC) questionnaire is used. The WOMAC is a self-administered questionnaire consisting of 24 items divided into 3 subscales. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total score
Measured: 9 weeks
Clinical Outcomes in Routine Evaluation
The translated and validated Swedish version of the Clinical Outcomes in Routine Evaluation (CORE-GP) is used to evaluate psychological wellbeing. The CORE-GP consists of 34 questions about how they have been feeling over the last week, using a 5-point scale (not at all, only occasionally, sometimes, often, most or all the time. The scale covers four dimensions: subjective well-being, problems/symptoms, life functioning, risk/harm
Measured: 9 weeks
Gastrointestinal Symptoms Rating Scale
To assess gastrointestinal symptoms the Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire is used. The questionnaire consists of 15 questions combined into five symptom clusters: reflux, abdominal pain, indigestion, diarrhoea and constipation. Each questions is rated on a 7-point likert scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms
Measured: 9 weeks
Pittsburgh Sleep Quality Index
To assess sleep quality and sleep disturbances over a one-month time interval the Pittsburgh Sleep Quality Index (PSQI) questionnaire is used. Each questionnaire's 19 self reported items belong to one of seven categories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction. The questionnaire consists of a combination of likert-type and open-ended questions. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances.
Measured: 9 weeks
International Physical Activity Questionnaire for the Elderly short form
The International Physical Activity Questionnaire for the Elderly (IPAQ-E) short form consists of 4 questions regarding time spend sitting, walking, heavy physical activities or sport or very heavy activities or sport
Measured: 9 weeks
Historical Physical Activity Questionnaire
The Historical Physical Activity Questionnaire HAPAQ assesses physical activity behaviour between the age of 20 to 65 years and consists of questions regarding physical activity, sports and labour performed per year, month and average minutes per week
Measured: 9 weeks
Food frequency questionnaire
The Meal-Q Food frequency questionnaire is used to assess if participants have altered dietary patterns during the intervention. The questionnaire consists of 174 questions about foods, dishes and drinks (including alcoholic drinks) as well as pictures of different portion sizes for cooked dishes, questions about meal order, eating behaviour (with regard to restaurant visits, fast food, salad buffets, salt on food, consumption of diet products) and supplements.
Measured: 9 weeks
Physical activity
Habitual physical activity will be assessed by accelerometery activity monitor during a week during waking time. Counts per minute are registered and converted into daily average times spent in sedentary behaviour, light-intensity physical activity, and moderate-to-vigorous intensity physical activity.
Measured: Only at baseline (week 1)
Muscle mass
Muscle mass is assessed with bioelectrical impedance (BIA)
Measured: 9 weeks
Fat mass
Fat mass is assessed with bioelectrical impedance (BIA)
Measured: 9 weeks
Body mass index
Body mass index (BMI) is calculated as weight (in kg)/ height^2 (in m^2)
Measured: 9 weeks
Waist circumference
Waist circumference is measured to the nearest 0.1 cm with a steel tape at the midpoint between iliac crest and lower costal marginBody mass index (BMI)
Measured: 9 weeks
Aerobic capacity
Aerobic capacity is assessed by a maximal walk test on a graded treadmill (Modified Bruce Protocol) where a further stage and time into the stage indicates a better aerobic fitness
Measured: 9 weeks
Balance
Balance by the single leg stance balance test with eyes open and eyes closed where longer time indicates a better balance
Measured: 9 weeks
30-sec repeated chair raise
Lower body muscle performance is assessed by the 30-sec repeated chair raise where more repetitions indicates a better performance
Measured: 9 weeks
Maximal leg strength
Maximal leg strength is assessed by the leg press exercise where a larger amount in kilograms lifted indicates a higher maximal leg strength
Measured: 9 weeks
Maximal handgrip strength
Maximal handgrip strength by the handgrip test where total amount of kilogram or kilogram per bodyweight indicates a higher total, or relative handgrip strength respectively
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start26 Aug 2024
- Primary completionJan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive FunctionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm randomized controlled trial that includes a double-blinded, two-armed intervention and a non-blinded control arm without any intervention
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353984
- Sponsor's protocol ID
- Minimeal 1.0
- Acronym
- Minimeal
- Status last verified
- Feb 2026
- First submitted
- 28 Feb 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tingo L, Veen J, Andersson P, Chatzopoulou M, Rode J, Andersson K, Kaya I, Rascon A, Edholm P, Brummer R, Bergh C, Hutchinson AN. Effects of a Nutritionally Balanced Between-Meal Food Product on Brain Function in Older Adults: Protocol for a Randomized Controlled Trial (the MiniMeal Study). JMIR Res Protoc. 2026 Sep 17;15:e94648. doi: 10.2196/94648.
PubMed 42752400
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Nutritionally Balanced In-between Meal Food Product on Cognitive Function in the Elderly - an Explorative Study
- ClinicalTrials.gov ID
- NCT06353984
- Acronym / sponsor ID
- Minimeal / Minimeal 1.0
- Conditions
- Cognitive Function
- Keywords
- cognitive function
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 9 Apr 2024 (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 overall aim of the present 9-week intervention study is to determine how a healthy drinkable in between meal affects cognitive function and brain activity in healthy adults 70 years and older. Secondary, the study also investigates the impact of the intervention on low grade inflammation, immune function, gut health, body composition, physical function, and well-being as secondary or exploratory outcomes. The study products have the potential to lower chronic low-grade inflammation in the elderly, improve nutrition and thereby contribute to healthy aging including cognitive function, and the study will also give additional insight regarding secondary and exploratory outcomes.
Detailed description
The current study is a nine week three-arm randomized controlled trial that includes a double-blinded, two-armed intervention and a non-blinded comparative arm without any intervention. This study will investigate the effects of a healthy in between meal consisting of processed oats and chickpeas on cognitive function and functional brain activity in healthy older men and women 70 years and older (primary endpoints) and explore the effect of the intervention product on blood markers, body composition, physical activity, physical function, and self-reported well-being in the earlier mentioned population (secondary endpoint). Furthermore, the study will give insight in the preventative value of the intervention product on earlier mentioned age-related conditions as well as adherence to the study product and gives guidance towards further research regarding the effect of food product on age related conditions. Participants will visit the study centre at seven occasions, one time before (pre visit) and six times during the study period to perform one or more tests and/or examinations. The pre visit takes place before the baseline, visit 1 and 2 are at baseline, and visit 3 and 4 are the mid-study-visits in week 3 and 6 of the interventional period. Visit 5 and 6 take place at the last interventional week, ie week 9. Data and sample collection takes place as following:
- visit 0: Eligibility screening and informed consent
- Week 1: visit 1 baseline: Body composition, blood samples, fecal samples, questionnaires and physical activity and function, cognitive function
- Week 1: visit 2 baseline fMRI: Structural MRI, RS-(MRI), N-back task fMRI, word recognition task
- Week 3: visit 3 intermediate visit I: Body composition, blood samples, questionnaires, compliance
- Week 6: visit 4 Intermediate visit I: Body composition, blood samples, questionnaires, compliance
- Week 9: visit 5 study end: same procedure as visit 1
- Week 9. Visit 6 study end: same procedure as visit 2
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm randomized controlled trial that includes a double-blinded, two-armed intervention and a non-blinded control arm without any intervention
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Minimeal productIntervention group receives the study product |
| Reference group | Active comparator | Dietary Supplement: Reference productReference group receives a reference product |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Signed informed consent prior to any study-related procedure
- Age 70 years and above
- Normal weight to overweight at the screening defined as BMI range 18.5-31.9
- Willing to abstain from regular consumption of medication known to alter gastrointestinal function or inflammatory status after being included and during the study
- Willingness to pick up study products and eat the products according to the instructions each day
Key exclusion criteria (31 listed)
- Diagnosis of type 1 and/or type 2 diabetes
- Immobile (defined as the inability to participate in all study-related procedures)
- History of complicated gastrointestinal surgery
- Diagnosed inflammatory bowel disease (IBD)
- Current diagnosis of psychiatric disease/s or syndromes
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 |
|---|---|---|
| Minimeal productIntervention product consisting of bioprocessed oats and chickpeas | Dietary supplement | Intervention group |
| Reference productReference product mimicking available soups and fruit drinks | Dietary supplement | Reference group |
Primary outcome
Functional brain activity
Time frame: 9 weeks
Functional brain activity will be measured by functional magnetic resonance imaging (fMRI)) during the n-back task
30 secondary outcomes
Fasting blood glucose/insulin
Time frame: 9 weeks
Blood fats/lipid status
Time frame: 9 weeks
Interleukin-6
Time frame: 9 weeks
High-sensitivity C-reactive protein
Time frame: 9 weeks
Tumor necrosis factor
Time frame: 9 weeks
Interferon-gamma
Time frame: 9 weeks
Zonulin
Time frame: 9 weeks
Intestinal fatty-acid binding protein
Time frame: 9 weeks
Cognitive function
Time frame: 9 weeks
Magnetic resonance imaging (MRI)
Time frame: 9 weeks
The Perceived Stress Scale
Time frame: 9 weeks
Hospital Anxiety and Depression Scale
Time frame: 9 weeks
SF 36
Time frame: 9 weeks
Western Ontario and McMaster Osteoarthritis Index
Time frame: 9 weeks
Clinical Outcomes in Routine Evaluation
Time frame: 9 weeks
Gastrointestinal Symptoms Rating Scale
Time frame: 9 weeks
Pittsburgh Sleep Quality Index
Time frame: 9 weeks
International Physical Activity Questionnaire for the Elderly short form
Time frame: 9 weeks
Historical Physical Activity Questionnaire
Time frame: 9 weeks
Food frequency questionnaire
Time frame: 9 weeks
Physical activity
Time frame: Only at baseline (week 1)
Muscle mass
Time frame: 9 weeks
Fat mass
Time frame: 9 weeks
Body mass index
Time frame: 9 weeks
Waist circumference
Time frame: 9 weeks
Aerobic capacity
Time frame: 9 weeks
Balance
Time frame: 9 weeks
30-sec repeated chair raise
Time frame: 9 weeks
Maximal leg strength
Time frame: 9 weeks
Maximal handgrip strength
Time frame: 9 weeks
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 18 Feb 2026.
- Derived from this study: PubMed 42752400Tingo L, Veen J, Andersson P, Chatzopoulou M, Rode J, Andersson K, Kaya I, Rascon A, Edholm P, Brummer R, Bergh C, Hutchinson AN. Effects of a Nutritionally Balanced Between-Meal Food Product on Brain Function in Older Adults: Protocol for a Randomized Controlled Trial (the MiniMeal Study). JMIR Res Protoc. 2026 Sep 17;15:e94648. doi: 10.2196/94648.
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Healthy Participants
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimeal product and Reference product in people with Cognitive Function, run by Örebro University, Sweden at 1 site in Sweden.
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 5 inclusion and 31 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: under way, not looking for participants, as of the sponsor's last update on 18 Feb 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 Sweden. 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?
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?
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?
Functional brain activity (time frame: 9 weeks). 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 NCT06353984, which also lists 1 linked publication.
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 18 Feb 2026.