Cognitive FunctionNCT04431843
the Efficacy and Safety of Spirulina Maxima Extract on Improvement of Cognitive Function
A study testing Spirulina maxima extract in people with Cognitive Function, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
This study was the evaluate the efficacy and safety of Spirulina maxima extract on the improvement of Cognitive Function Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function
- What is being tested?
- Spirulina maxima extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Mar 2020to 26 Nov 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons who are at least 60 years of age at screening
- Persons who have Korean Mini-Mental Status Examination(K-MMSE) result in 25-28 points
- Persons who agree to voluntary participation and to comply with the Notice after fully hearing and understanding the details of this human trial
Who cannot join
- Patients with a past history of treatment with Axis I disorder in SCID(Structured Clinical Interview for DSM-IV) which is a structured clinical interview in the Diagnostic and Statistical Manual of Mental Disorders at Screening or who have been treated within the last 3 years
- Patients with BMI(Body Mass Index)<18.5 kg/m^ or 35 kg/m^≤BMI(Body Mass Index)
- Patients with alcohol abuse or dependence within the last 3 months
- Patients who have clinically significant following severe illness (i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.)
- Patients with a history of clinically significant hypersensitivity to Spirulina Maxima
- Patients taking medicines, health functional foods or herbal medicines related to the improvement of cognitive function and memory within 1 month before screening
Show all 13Show fewer
- Patients who ingested Spirulina Maxima extract's health functional food within 1 month before screening
- Patients who whole blood donation within 1 months before the first ingestion or Component blood donation within 2 weeks
- Patients who participate in another human trial within 3 months
- Those who show the following results in the Laboratory test
- AST, ALT > 3 times upper limit of the normal range
- Other significant laboratory test opinion
- Patients who are deemed unsuitable for participating in the human trial due to other reasons
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Psychiatry, Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
About this study
Official title: A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Spirulina Maxima Extract on Improvement of Cognitive Function
This study was the evaluate the efficacy and safety of Spirulina maxima extract on the improvement of Cognitive Function
Read the detailed description
This study was 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate. 80 subjects participated in Spirulina maxima extract or placebo group. To evaluate the changes in the evaluation items when Spirulina maxima extract was taken 12 weeks compared with placebo.
- Conditions
- Cognitive Function
- Being tested
- Spirulina maxima extract, Placebo
- Keywords
- Spirulina maxima Extract, Cognitive Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirulina maxima extractDietary supplement
once a day for 2 p.o., after breakfast and dinner(1.52 g/day, Spirulina maxima extract for 1.5 g/day) for 12 week
PlaceboDietary supplement
once a day for 2 p.o., after breakfast and dinner(1.52 g/day, Spirulina maxima extract for 0 g/day) for 12 week
| Study group | Role | What they receive |
|---|---|---|
| Spirulina maxima extract | Experimental | Spirulina maxima extract for 1.5 g/day Receives: Dietary Supplement: Spirulina maxima extract |
| Placebo | Placebo comparator | Spirulina maxima extract for 0 g/day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Visual learning test
Visual learning test of CNT(Computerized neurocognitive function test) was measured in baseline and 12 week. And changes of result from the test were utilized.
Measured: 12 weeks
Changes of Visual working memory test
Visual working memory test of WMT(working memory tasks) was measured in baseline and 12 week. And changes of result from the test were utilized.
Measured: 12 weeks
Changes of Verbal learning test
Verbal learning test of CNT(Computerized neurocognitive function test) was measured in baseline and 12 week. And changes of result from the test were utilized.
Measured: 12 weeks
Secondary outcomes (4)
MoCA-K; Korean Version of the Montreal Cognitive Assessment
The cognitive function evaluation using the Montreal Cognitive Assessment(MoCA-K) is a total of 8 items, and evaluates cognitive functions such as time / execution power, vocabulary, memory, attention, sentence, abstraction, delayed recall, and orientation.
Time / execution power's total score is 5 points, vocabulary's total score is 3 points, attention's total score is 3 points, sentence's total score is 3 points, abstraction's total score is 2 points, delayed recall's total score is 5 points, orientation's total score is 6 points. It takes about 10 minutes to complete, and the total score is 30 points and total score make sum score. A score of 23 points or more is regarded as normal. If you have less than 6 years of education, add 1 point.
It takes about 10 minutes to complete, and the score is 30 points. A score of 23 points or more is regarded as normal. If you have less than 6 years of education, add 1 point.
Measured: 12 weeks
Changes of Auditory continuous performance test
Auditory continuous performance test of CNT(Computerized neurocognitive function test) was measured in baseline and 12 week. And changes of result from the test were utilized.
Measured: 12 weeks
BDNF; Brain-derived neurotrophic factor
Brain-derived neurotrophic factor(BDNF)(pg/mL) was measured in baseline and 12 week.
Measured: 12 weeks
Changes of TAS(Total antioxidant status)
Total antioxidant status(TAS) was measured in baseline and 12 week. And changes of result from the test were utilized.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start17 Mar 2020
- Primary completion26 Nov 2020
- Study completion26 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Chul Chung, Chonbuk National University Hospital
- Investigators
- Young-chul Chung, MD, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431843
- Sponsor's protocol ID
- KIOST-CF-SM2
- Status last verified
- Feb 2023
- First submitted
- 9 Jun 2020
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Spirulina Maxima Extract on Improvement of Cognitive Function
- ClinicalTrials.gov ID
- NCT04431843
- Acronym / sponsor ID
- KIOST-CF-SM2
- Conditions
- Cognitive Function
- Keywords
- Spirulina maxima Extract, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 26 Nov 2020 (actual)
- Study completion
- 26 Nov 2020 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was the evaluate the efficacy and safety of Spirulina maxima extract on the improvement of Cognitive Function
Detailed description
This study was 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate. 80 subjects participated in Spirulina maxima extract or placebo group. To evaluate the changes in the evaluation items when Spirulina maxima extract was taken 12 weeks compared with placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spirulina maxima extract | Experimental | Dietary Supplement: Spirulina maxima extractSpirulina maxima extract for 1.5 g/day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSpirulina maxima extract for 0 g/day |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persons who are at least 60 years of age at screening
- Persons who have Korean Mini-Mental Status Examination(K-MMSE) result in 25-28 points
- Persons who agree to voluntary participation and to comply with the Notice after fully hearing and understanding the details of this human trial
Key exclusion criteria (13 listed)
- Patients with a past history of treatment with Axis I disorder in SCID(Structured Clinical Interview for DSM-IV) which is a structured clinical interview in the Diagnostic and Statistical Manual of Mental Disorders at Screening or who have been treated within the last 3 years
- Patients with BMI(Body Mass Index)<18.5 kg/m^ or 35 kg/m^≤BMI(Body Mass Index)
- Patients with alcohol abuse or dependence within the last 3 months
- Patients who have clinically significant following severe illness (i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.)
- Patients with a history of clinically significant hypersensitivity to Spirulina Maxima
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 |
|---|---|---|
| Spirulina maxima extractonce a day for 2 p.o., after breakfast and dinner(1.52 g/day, Spirulina maxima extract for 1.5 g/day) for 12 week | Dietary supplement | Spirulina maxima extract |
| Placeboonce a day for 2 p.o., after breakfast and dinner(1.52 g/day, Spirulina maxima extract for 0 g/day) for 12 week | Dietary supplement | Placebo |
Primary outcome
Changes of Visual learning test
Time frame: 12 weeks
Visual learning test of CNT(Computerized neurocognitive function test) was measured in baseline and 12 week. And changes of result from the test were utilized.
Changes of Visual working memory test
Time frame: 12 weeks
Visual working memory test of WMT(working memory tasks) was measured in baseline and 12 week. And changes of result from the test were utilized.
Changes of Verbal learning test
Time frame: 12 weeks
Verbal learning test of CNT(Computerized neurocognitive function test) was measured in baseline and 12 week. And changes of result from the test were utilized.
4 secondary outcomes
MoCA-K; Korean Version of the Montreal Cognitive Assessment
Time frame: 12 weeks
Changes of Auditory continuous performance test
Time frame: 12 weeks
BDNF; Brain-derived neurotrophic factor
Time frame: 12 weeks
Changes of TAS(Total antioxidant status)
Time frame: 12 weeks
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 10 Feb 2023.
Related trials for Cognitive Function
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
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.
Young-chul Chung, MD principal investigator
Chonbuk National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirulina maxima extract in people with Cognitive Function, run by Chonbuk National University Hospital at 1 site in South Korea.
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 3 inclusion and 13 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 10 Feb 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 South Korea. 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?
Changes of Visual learning test (time frame: 12 weeks). The study lists 3 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 10 Feb 2023.