Arachidonic acid supplementation to improve cognitive impairment of schizophrenia
| ISRCTN | ISRCTN31248612 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31248612 |
- Submission date
- 04/07/2024
- Registration date
- 05/07/2024
- Last edited
- 29/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Cognitive impairment associated with schizophrenia (CIAS) is characterized by a broad pattern of cognitive deficits ranging from attention and working memory to social cognition and language. Currently, the main antipsychotic maintenance treatment has a limited substantial effect on improving cognitive performance and barely makes a full recovery in socialization. In the brain, arachidonic acid (AA) is mainly esterified into lipids, serving as cellular membrane components for the dynamic morphological change of neuron cells and signaling molecules during neurotransmission.
Given the multi-involvements of AA in brain development and neuronal activities, this study aims to investigate the efficacy of AA supplementation in improving cognitive function among SZ patients and to elucidate the underlying mechanisms, thereby offering new perspectives and strategies for the treatment of cognitive impairments.
Who can participate?
Patients with SZ and healthy participants registered at the Suzhou Guangji Hospital, Jiangsu Province, China.
What does the study involve?
Patients and healthy participants are randomly assigned to powdered FA supplements containing AA or the AA-free placebo once daily for nutraceutical supplementation.
The niacin skin flushing response, and cognition performance are assessed by trained psychiatrists at the beginning, midpoint, and endpoint. Blood samples are taken at the beginning and endpoint.
What are the possible benefits and risks of participating?
Participants who receive the AA may benefit from improved cognitive performance. There are no known risks involved with participating.
Where is the study run from?
1. Shanghai Jiao Tong University (China)
2. Suzhou Guangji Hospital, Jiangsu Province (China)
When is the study starting and how long is it expected to run for?
November 2020 to December 2024
Who is funding the study?
National Natural Science Foundation of China
Interdisciplinary Program of Shanghai Jiao Tong University (China)
Who is the main contact?
1. Prof. Chunling Wan, clwan@sjtu.edu.cn
1. Dr. Xiaowen Hu, xiaowen@sjtu.edu.cn
2. Yan Gao, Gao_Yan@sjtu.edu.cn
Contact information
Principal Investigator
No. 1954, Huashan Road
Shanghai
200030
China
 ORCID ID |
0000-0002-0372-0041 |
|---|---|
| Phone | + 86 21 62833148 |
| clwan@sjtu.edu.cn |
Public, Scientific
No. 1954, Huashan Road
Shanghai
200030
China
| Phone | + 86 21 62833148 |
|---|---|
| xiaowen@sjtu.edu.cn |
Public, Scientific
No. 1954, Huashan Road
Shanghai
200030
China
| ORCID ID |
0000-0001-6905-0143 |
|---|---|
| Phone | + 86 21 62833148 |
| Gao_Yan@sjtu.edu.cn |
Study information
| Study design | Single-center interventional double-blinded randomized placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Exploring the impact and underlying mechanisms of arachidonic acid supplementation on cognitive impairment in schizophrenia: a double-blinded, placebo-controlled, randomized study |
| Study objectives | This study aims to evaluate the therapeutic effects and underlying mechanisms of arachidonic acid supplementation on cognitive improvement. |
| Ethics approval(s) |
Approved 06/11/2020, Research Ethics Committee of Bio-X Institutes, Shanghai Jiao Tong University (No. 1954 Huashan Road, Xuhui District, Shanghai City, Shanghai, 200030, China; +86 21-62932151; bio-x@sjtu.edu.cn), ref: No. M202006 |
| Health condition(s) or problem(s) studied | Schizophrenia |
| Intervention | This was designed for a double-blinded, placebo-controlled, randomized clinical trial (RCT) of oral arachidonic acid (AA) supplementation to identify whether the adjunctive intervention can improve cognitive performance in schizophrenia and healthy controls. Patients were recruited and randomly assigned to powdered FA supplements containing 338 mg AA or the AA-free placebo once daily for a six-week adjunctive intervention. The AA supplements and the placebo were identical in powder particle size, color, volume, and packaging. The diet of inpatients remains consistent during their hospital stay. Healthy volunteers were recruited to FA supplements containing 1400 mg AA for an eight-week intervention and four-week wash-out period. Stratified randomisation based on patient gender, age, height, weight, and cognitive performance measured by CANTAB system. We are utilizing an online tool for this process, which ensures that each stratum is randomly assigned participants. |
| Intervention type | Supplement |
| Primary outcome measure | Cognitive function was measured using the Cambridge Neuropsychological Test Automated Battery® (CANTAB®) system at baseline, week 3, and 6 |
| Secondary outcome measures | 1. RBC's lipids and fatty acids were measured using gas chromatography-mass spectrometry at baseline and week 6 2. Mitochondria lipids measured using ultrahigh-performance liquid chromatography quadrupole orbitrap mass spectrometry at baseline and endpoint 3. RNA sequencing of white blood cells was conducted at baseline and endpoint 4. Niacin skin flushing response test using 6 concentrations (triple gradient dilution from 60 mM) of niacin dropped onto the skin at baseline, week 3, and 6 |
| Overall study start date | 02/11/2020 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 80 = 40 in AA group and 40 in AA-free placebo group |
| Total final enrolment | 62 |
| Key inclusion criteria | 1. Patients of SZ were diagnosed according to the International Classification of Diseases 10th edition (ICD-10) 2. The patient's family members or legal guardians fully understood the content of this study and signed informed consent |
| Key exclusion criteria | 1. Patients should not have a history of other mental disorders, neurological disorders, serious physical diseases, traumatic brain injury, substance abuse, or dependence 2. Healthy controls should not have any current or previous psychiatric history or family history, as assessed by the Mini-International Neuropsychiatric Interview (M.I.N.I.) |
| Date of first enrolment | 08/11/2020 |
| Date of final enrolment | 22/02/2021 |
Locations
Countries of recruitment
- China
Study participating centre
Jiangsu Province
215131
China
Sponsor information
Government
No. 83 Shuangqing Road, Haidian District
Beijing
100085
China
| bic@nsfc.gov.cn | |
| Website | https://www.nsfc.gov.cn/english/site_1/index.html |
"ROR" |
https://ror.org/01h0zpd94 |
University/education
No. 1954, Huashan Road
Shanghai
200030
China
| service@sjtu.edu.cn | |
| Website | https://en.sjtu.edu.cn/ |
|
"ROR" |
https://ror.org/0220qvk04 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Government organisation / Universities (academic only)
- Alternative name(s)
- 上海交通大学, 上海交通大學, Nanyang Public School, Nan Yang College of Chiao Tung, National Chiao Tung University, Jiao Tong University, SJTU
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. |
Editorial Notes
28/08/2024: The contact for the National Natural Science Foundation of China was updated.
05/07/2024: Trial's existence confirmed by the Research Ethics Committee of Bio-X Institutes, Shanghai Jiao Tong University.
