Age-related Cognitive DeclineSCANBerryNCT05693441
Study on the Chronic and Acute Effects of Nordic Berry Beverage on Cognitive Function
A study testing Active berry product and Reference berry-like product in people with Age-related Cognitive Decline, run by Aventure AB at 1 site in Sweden.
Trial summary
The aim of the current study is to investigate whether acute and 12-weeks daily intake of Nordic berries can improve cognitive abilities of adults without cognitive disease, and whether the effect can be linked to changes in metabolic parameters. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-related Cognitive Decline
- What is being tested?
- Active berry product and Reference berry-like product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteSweden
- Study dates
- 17 Jan 2023to 22 Jun 2023
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60-85 years.
- Capable and willing to give written informed consent.
- Capable and willing to perform cognitive testing in Swedish (mastering the Swedish language, functional vision and hearing or the use of visual or hearing aids during testing).
- Capable and willing to ingest the study beverage for 12 weeks and to follow the instructions given.
- Agree to maintain consistent dietary habits and physical activity levels for the duration of the study
Who cannot join
- Known to be affected by major neurocognitive disorder/dementia or low score on cognitive screening test (Mini Mental State Examination (MMSE) score less than 24.
- Affected by other medical condition(s) or medication(s) known to significantly affect cognitive function.
- Past history of brain damage, significant head trauma (including loss of consciousness as a result), brain surgery or stroke.
- Underweight (BMI <18.5).
- Significant psychiatric disorders with current symptoms.
- Type 1 diabetes, recently diagnosis of Type 2 diabetes (<12 months) or ongoing insulin treatment.
Show all 22Show fewer
- Ongoing treatment for malignancy*.
- Significant change in medication over the last 3 months.
- Undergoing antibiotic therapy for the last 3 months prior to inclusion in the study.
- Blood donation before (3 months) or during the study period.
- Planned major intervention in health care or change in medication over the next 3 months (study period).
- Currently active smoker or regular use of other nicotine products.
- Drug or alcohol abuse.
- Conditions with major impact on the gastrointestinal tract (such as Crohn's disease, ulcerative colitis, diagnosed gluten intolerance, undertaken intestinal resection or weight loss surgery).
- Allergy / intolerance to berries or other ingredients in the study products (i.e., colorants, aromas, starch).
- Vegetarians / vegans.
- Daily, regular high consumption (approximately 1 dl or more per day) of berries or juices / marmalade / products with high content of bilberries and lingonberries. (Can be recruited if consumption has ceased to less than 5 grams of berries per day at least 1 month before visit 1.).
- Taking supplements with potential cognitive effects (e.g., omega-3, ginko biloba, Souvenaid), or containing grape and berry extracts or probiotics (capsules or ProViva). (Can be recruited if this intake ceases at least one month before visit 1).
- Planned longer absence/vacation during the next 3 months (study period).
- Sharing household with someone participating in the current study
- Concurrent participation in other clinical intervention trials (dietary/pharmacological).
- Other reasons that make the SD in consultation with the PI deem the person inappropriate to include. *basalioma exempt from exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Chronic and Acute Effects of Nordic Berry Beverage on Cognitive Function, Cardiometabolic Risk Markers and Gut Microbiome: A Randomized, Double-blind, Placebo-controlled Intervention
The aim of the current study is to investigate whether acute and 12-weeks daily intake of Nordic berries can improve cognitive abilities of adults without cognitive disease, and whether the effect can be linked to changes in metabolic parameters.
Read the detailed description
The study will be conducted with a randomized, double-blind, parallel-group (2 arms) placebo-controlled, single-center interventional design. The aim is to investigate the effects on cognitive function and cardiometabolic risk markers after acute and 12 weeks daily intake of a berry product vs. a reference product. The reference will be isocaloric and matched in taste, appearance, volume and macronutrient composition to the active berry product.
Two groups, each of 30 volunteers, are studied. One group of volunteers will consume the berry product while the other group act as control and will consume the reference product.
Each volunteer will be seen for a screening visit as well as one pre- and one post-intervention visit at the clinic. In addition, there will be 2 follow-up calls in between visits. Pre- and post intervention visits will include cognitive assessment with the CANTAB battery (episodic memory and verbal recognition memory), as well as additional cognitive and behavioral tests. Cardiometabolic parameters will be addressed (plasma glucose, insulin, inflammatory markers, blood lipids, body composition) and fecal samples collected.
- Conditions
- Age-related Cognitive Decline
- Being tested
- Active berry product, Reference berry-like product
- Keywords
- cognitive function, memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active berry productOther
Subjects should consume the active product containing nordic berries daily during the 12 week intervention period.
Reference berry-like productOther
Also called Inactive control
Subjects should consume a reference product (isocaloric to active product, containing berry aromas and colouring but no actual berry compounds) daily during the 12 week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Active berry product | Active comparator | Once daily consumption over the period of the study Receives: Other: Active berry product |
| Reference berry-like product | Placebo comparator | Once daily consumption over the period of the study Receives: Other: Reference berry-like product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive measures-memory
Episodic memory - assessed using computerized cognitive battery including PAL (paired associates learning) test.
Measured: Change from baseline following 12 weeks daily consumption, compared to control
Cognitive measures-memory
Episodic memory - assessed using computerized cognitive battery including VRM (verbal recognition memory) test
Measured: Change from baseline following 12 weeks daily consumption, compared to control
Cognitive measures - memory
Working memory - assessed using computerized cognitive battery including SWM (spatial working memory) test.
Measured: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Cognitive measures - memory
Working memory - assessed using computerized cognitive battery including SDPT (symbol digits processing test).
Measured: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Cognitive measures - executive function
Executive function - assessed using computerized cognitive battery including TMT (trail making test) A \& B.
Measured: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Cognitive measures - executive function
Executive function - assessed using computerized cognitive battery including PASAT (paced auditory serial addition test).
Measured: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Cognitive measures - executive function
Executive function - assessed using computerized cognitive battery including Stroop test.
Measured: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Cognitive measures - executive function
Executive function, verbal fluency - assessed using computerized cognitive battery including F-A-S test measuring word fluency
Measured: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Cognitive measures - attention
Attention, reaction time - assessed using computerized cognitive battery including RTI (reaction time) test.
Measured: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Cognitive measures
Global cognitive function - assessed by calculating a z-score from the cognitive battery score outcomes
Measured: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Secondary outcomes (25)
Circulating plasma biomarkers relating to cognitive function
Brain derived neurotrophic factor (BDNF)
Measured: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Mood measurement
assessed using SCAS (the Swedish Core Affect Scale) mood questionnaire. A validated self-report measure of affective state. The SCAS comprises of 12 affective states that subjects rate on a scale from 1 - 10.
Measured: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Self-reported quality of life
assessed using the quality of life scale from the EQ-5D (EuroQol 5 Dimension) self-report survey. The subject grades their current overall quality of life on a scale 0-100.
Measured: Difference from baseline vs control following 12 weeks of daily consumption
Well-being measurement
Assessed with World Health Organization- Five Well-Being Index (WHO-5). A validated 5 item scale for self-reporting levels of perceived well-being over the last two weeks. Items are rated using a 5-point scale.
Measured: Difference from baseline vs control following 12 weeks of daily consumption
Subjective memory
Assessed using 3 simple questions about the subject's own memory evaluation. The subject is asked to rate their memory function (scale 0 to 7), how they percieve their own memory is working compared to others in the same age (0 to 5) and if anyone close to them has expressed concern over the subjects' memory
Measured: Difference from baseline vs control following 12 weeks of daily consumption
Cardiometabolic risk factor
blood pressure (SBP)
Measured: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Cardiometabolic risk factor
blood pressure (DBP)
Measured: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Cardiometabolic risk factor
Heart rate (HR)
Measured: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Body composition
Body weight (kg)
Measured: Change from baseline following 12 weeks daily consumption, compared to control
Body composition
Body mass index (BMI) (e.g., weight (kg) and height (m) will be combined to report BMI in kg/m^2).
Measured: Change from baseline following 12 weeks daily consumption, compared to control
Body composition
body fat % (measured by bioelectrical impedance analysis)
Measured: Change from baseline following 12 weeks daily consumption, compared to control
Body composition
Waist circumference (cm)
Measured: Change from baseline following 12 weeks daily consumption, compared to control
Biomarkers of glycemia
glucose levels in blood
Measured: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Biomarkers of glycemia
insulin levels in blood
Measured: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Biomarkers of glycemia
HOMA-IR (insulin resistance index, calculated based on fasting glucose and insulin levels)
Measured: Change from baseline following 12 weeks daily consumption, compared to control
Biomarkers of glycemia
Fructosamine levels in blood
Measured: Change from baseline following 12 weeks daily consumption, compared to control
Biomarkers of lipemia in blood plasma
triacylglycerols
Measured: Difference from baseline vs control following 12 weeks of daily consumption
Biomarkers of lipemia in blood plasma
total cholesterol
Measured: Difference from baseline vs control following 12 weeks of daily consumption
Biomarkers of lipemia in blood plasma
HDL-cholesterol
Measured: Difference from baseline vs control following 12 weeks of daily consumption
Biomarkers of lipemia in blood plasma
LDL-cholesterol
Measured: Difference from baseline vs control following 12 weeks of daily consumption
Biomarkers of lipemia in blood plasma
ApoB/A1
Measured: Difference from baseline vs control following 12 weeks of daily consumption
Biomarker endothelial function in blood plasma
sVCAM-1
Measured: Difference from baseline vs control following 12 weeks of daily consumption
Biomarkers of liver function in blood plasma
ALAT
Measured: Difference from baseline vs control following 12 weeks of daily consumption
Biomarkers of inflammation and oxidative stress blood plasma
Interleukin
Measured: Difference from baseline vs control following 12 weeks of daily consumption
Biomarkers of inflammation and oxidative stress blood plasma
acute phase proteins (C-reactive protein)
Measured: Difference from baseline vs control following 12 weeks of daily consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start17 Jan 2023
- Primary completion22 Jun 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Cognitive DeclineStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aventure AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Berry Lab AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693441
- Sponsor's protocol ID
- SCANBerry2022
- Acronym
- SCANBerry
- Status last verified
- Jul 2023
- First submitted
- 17 Nov 2022
- Last updated
- 6 Jul 2023
- 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 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Chronic and Acute Effects of Nordic Berry Beverage on Cognitive Function, Cardiometabolic Risk Markers and Gut Microbiome: A Randomized, Double-blind, Placebo-controlled Intervention
- ClinicalTrials.gov ID
- NCT05693441
- Acronym / sponsor ID
- SCANBerry / SCANBerry2022
- Conditions
- Age-related Cognitive Decline
- Keywords
- cognitive function, memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Aventure ABIndustry (pharma, biotech, devices)
- Collaborators
- Berry Lab AB
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 23 Jan 2023 (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 aim of the current study is to investigate whether acute and 12-weeks daily intake of Nordic berries can improve cognitive abilities of adults without cognitive disease, and whether the effect can be linked to changes in metabolic parameters.
Detailed description
The study will be conducted with a randomized, double-blind, parallel-group (2 arms) placebo-controlled, single-center interventional design. The aim is to investigate the effects on cognitive function and cardiometabolic risk markers after acute and 12 weeks daily intake of a berry product vs. a reference product. The reference will be isocaloric and matched in taste, appearance, volume and macronutrient composition to the active berry product.
Two groups, each of 30 volunteers, are studied. One group of volunteers will consume the berry product while the other group act as control and will consume the reference product.
Each volunteer will be seen for a screening visit as well as one pre- and one post-intervention visit at the clinic. In addition, there will be 2 follow-up calls in between visits. Pre- and post intervention visits will include cognitive assessment with the CANTAB battery (episodic memory and verbal recognition memory), as well as additional cognitive and behavioral tests. Cardiometabolic parameters will be addressed (plasma glucose, insulin, inflammatory markers, blood lipids, body composition) and fecal samples collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active berry product | Active comparator | Other: Active berry productOnce daily consumption over the period of the study |
| Reference berry-like product | Placebo comparator | Other: Reference berry-like productOnce daily consumption over the period of the study |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 60-85 years.
- Capable and willing to give written informed consent.
- Capable and willing to perform cognitive testing in Swedish (mastering the Swedish language, functional vision and hearing or the use of visual or hearing aids during testing).
- Capable and willing to ingest the study beverage for 12 weeks and to follow the instructions given.
- Agree to maintain consistent dietary habits and physical activity levels for the duration of the study
Key exclusion criteria (22 listed)
- Known to be affected by major neurocognitive disorder/dementia or low score on cognitive screening test (Mini Mental State Examination (MMSE) score less than 24.
- Affected by other medical condition(s) or medication(s) known to significantly affect cognitive function.
- Past history of brain damage, significant head trauma (including loss of consciousness as a result), brain surgery or stroke.
- Underweight (BMI <18.5).
- Significant psychiatric disorders with current symptoms.
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 |
|---|---|---|
| Active berry productSubjects should consume the active product containing nordic berries daily during the 12 week intervention period. | Other | Active berry product |
| Reference berry-like productAlso: Inactive controlSubjects should consume a reference product (isocaloric to active product, containing berry aromas and colouring but no actual berry compounds) daily during the 12 week intervention period. | Other | Reference berry-like product |
Primary outcome
Cognitive measures-memory
Time frame: Change from baseline following 12 weeks daily consumption, compared to control
Episodic memory - assessed using computerized cognitive battery including PAL (paired associates learning) test.
Cognitive measures-memory
Time frame: Change from baseline following 12 weeks daily consumption, compared to control
Episodic memory - assessed using computerized cognitive battery including VRM (verbal recognition memory) test
Cognitive measures - memory
Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Working memory - assessed using computerized cognitive battery including SWM (spatial working memory) test.
Cognitive measures - memory
Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Working memory - assessed using computerized cognitive battery including SDPT (symbol digits processing test).
Cognitive measures - executive function
Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Executive function - assessed using computerized cognitive battery including TMT (trail making test) A \& B.
Cognitive measures - executive function
Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Executive function - assessed using computerized cognitive battery including PASAT (paced auditory serial addition test).
Cognitive measures - executive function
Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Executive function - assessed using computerized cognitive battery including Stroop test.
Cognitive measures - executive function
Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Executive function, verbal fluency - assessed using computerized cognitive battery including F-A-S test measuring word fluency
Cognitive measures - attention
Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Attention, reaction time - assessed using computerized cognitive battery including RTI (reaction time) test.
Cognitive measures
Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Global cognitive function - assessed by calculating a z-score from the cognitive battery score outcomes
25 secondary outcomes
Circulating plasma biomarkers relating to cognitive function
Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Mood measurement
Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Self-reported quality of life
Time frame: Difference from baseline vs control following 12 weeks of daily consumption
Well-being measurement
Time frame: Difference from baseline vs control following 12 weeks of daily consumption
Subjective memory
Time frame: Difference from baseline vs control following 12 weeks of daily consumption
Cardiometabolic risk factor
Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Cardiometabolic risk factor
Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Cardiometabolic risk factor
Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Body composition
Time frame: Change from baseline following 12 weeks daily consumption, compared to control
Body composition
Time frame: Change from baseline following 12 weeks daily consumption, compared to control
Body composition
Time frame: Change from baseline following 12 weeks daily consumption, compared to control
Body composition
Time frame: Change from baseline following 12 weeks daily consumption, compared to control
Biomarkers of glycemia
Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Biomarkers of glycemia
Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Biomarkers of glycemia
Time frame: Change from baseline following 12 weeks daily consumption, compared to control
Biomarkers of glycemia
Time frame: Change from baseline following 12 weeks daily consumption, compared to control
Biomarkers of lipemia in blood plasma
Time frame: Difference from baseline vs control following 12 weeks of daily consumption
Biomarkers of lipemia in blood plasma
Time frame: Difference from baseline vs control following 12 weeks of daily consumption
Biomarkers of lipemia in blood plasma
Time frame: Difference from baseline vs control following 12 weeks of daily consumption
Biomarkers of lipemia in blood plasma
Time frame: Difference from baseline vs control following 12 weeks of daily consumption
Biomarkers of lipemia in blood plasma
Time frame: Difference from baseline vs control following 12 weeks of daily consumption
Biomarker endothelial function in blood plasma
Time frame: Difference from baseline vs control following 12 weeks of daily consumption
Biomarkers of liver function in blood plasma
Time frame: Difference from baseline vs control following 12 weeks of daily consumption
Biomarkers of inflammation and oxidative stress blood plasma
Time frame: Difference from baseline vs control following 12 weeks of daily consumption
Biomarkers of inflammation and oxidative stress blood plasma
Time frame: Difference from baseline vs control following 12 weeks of daily consumption
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 6 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Age-related Cognitive Decline
RecruitingPhase 1
Acute Effects of THC in Older Adult
Age-related Cognitive Decline
Recruiting
Epigenetic Enhancement of Cognitive Training in Aging Mood and Schizophrenia Spectrum Disorder Populations
Bipolar Disorder (BD), Depression - Major Depressive Disorder
Active, not recruitingObservational study
The Dortmund Vital Study: Impact of Biological and Lifestyle Factors on Cognitive Performace and Work Ability
Age-related Cognitive Decline
RecruitingObservational study
Older Breast Cancer Patients: Risk for Cognitive Decline
Cancer, Breast, Age-related Cognitive Decline
Recruiting
Health Ahead Comparative Effectiveness Study
Health Services Accessibility, Rural Health
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 Active berry product and Reference berry-like product in people with Age-related Cognitive Decline, run by Aventure AB 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 22 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 6 Jul 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 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. 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?
Cognitive measures-memory (time frame: Change from baseline following 12 weeks daily consumption, compared to control). The study lists 10 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 6 Jul 2023.