Attention Deficit Hyperactivity DisorderNCT03439111
Standardized Lycium Chinense Fruit Extract Enhances Attention and Cognitive Function in Healthy Young People
A study testing Standardized Lycium chinense Fruit Extract (LCF) capsules in people with Attention Deficit Hyperactivity Disorder, run by Biomix at 1 site in South Korea.
Trial summary
Lycium chinense fruit (LCF) is widely distributed in East Asia that has been used traditionally for anti-aging purposes. This study was performed to examine the effects of LCF on attention and cognitive function in healthy young people. Read more about this study
- Who is it for?
- Ages 14 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Standardized Lycium chinense Fruit Extract (LCF) capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2011to 30 Apr 2013
- 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 14 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age between 14 and 24 years old
- Male or female
- Ability to understand the objectives of the study and agreed to abide by the required rules during the study.
- If participants were aged between 14 and 20 years old, they and their parents had to provide informed consent.
Who cannot join
- Diagnosis of ADHD (any subtype) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
- Diagnosis of a developmental disorder
- Pregnant or breastfeeding women and women with the possibility of getting pregnant
- Gastrointestinal disease or history of gastrointestinal surgery, which might affect the absorption of study materials
- Significant neurological (epilepsy, mental retardation, or stroke) or medical illnesses (diabetes, hypertension, or cardiovascular diseases),
- Participation in other clinical studies during the four weeks preceding the start of the study
- More than 1.5 times normal limit of ALT or AST.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standardized Lycium Chinense Fruit Extract Enhances Attention and Cognitive Function in Healthy Young People: A Double-blind, Randomized, Placebo-Controlled, Crossover Trial
Lycium chinense fruit (LCF) is widely distributed in East Asia that has been used traditionally for anti-aging purposes. This study was performed to examine the effects of LCF on attention and cognitive function in healthy young people. An 11-week, double-blind, randomized, placebo-controlled, crossover trial was conducted.
Read the detailed description
The Computerized Neurocognitive function Test (CNT), the Korean version of the Attention-deficit/hyperactivity disorder (ADHD) Rating Scale-IV (K-ADHD-RS-IV), the Clinical Global Impression (CGI) rating scale, the Frankfurt Attention Inventory (FAIR), and resting-state electroencephalogram (EEG) were conducted before and after the experiment.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Standardized Lycium chinense Fruit Extract (LCF) capsules
- Keywords
- Lycium chinense fruit
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Lycium chinense Fruit Extract (LCF) capsulesDietary supplement
All dried water extracts and capsules of the Standardized Lycium chinense Fruit Extract (LCF) and Standardized Lycium chinense Fruit Extract (LCF)-matched placebo capsules used in the present study were manufactured and provided by the BIOMIX Company (Ilsan City, Korea).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intervention : Placebo + Standardized Lycium chinense Fruit Extract (LCF) capsules Placebo Comparator : Oral administration, 600 mg two capsules (600 mg of Starch/capsule) three times a day for 4 week treatment 3 week wash-out Experimental : Oral administration, 600 mg two capsules (146 mg of the Standardized Lycium chinense Fruit Extract (LCF)/capsule) three times a day for 4 week treatment Receives: Dietary Supplement: Standardized Lycium chinense Fruit Extract (LCF) capsules |
| Experimental | Experimental | Intervention : Standardized Lycium chinense Fruit Extract (LCF) capsules + Placebo Experimental : Oral administration, 600 mg two capsules (146 mg of the Standardized Lycium chinense Fruit Extract (LCF)/capsule) three times a day for 4 week treatment 3 week wash-out Placebo Comparator : Oral administration, 600 mg two capsules (600 mg of Starch/capsule) three times a day for 4 week treatment Receives: Dietary Supplement: Standardized Lycium chinense Fruit Extract (LCF) capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Computerized neurocognitive Function Test (CNT)
Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment
Measured: Before treatment, 4 and 11 weeks after treatment
Secondary outcomes (4)
Korean version of Attention-deficit/hyperactivity disorder (ADHD) Rating Scale-IV (K-ADHD-RS-IV)
Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment
Measured: Before treatment, 4 and 11 weeks after treatment
The Clinical Global Impression (CGI) rating scale
Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment
Measured: Before treatment, 4 and 11 weeks after treatment
The Frankfurt Attention Inventory (FAIR)
Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment
Measured: Before treatment, 4 and 11 weeks after treatment
Resting-state electroencephalogram (EEG)
Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment
Measured: Before treatment, 4 and 11 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start1 Nov 2011
- Primary completion30 Apr 2013
- Study completion30 Apr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants receive one of two (or more) alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyunghee University
- Responsible party
- Sponsor
- Investigators
- Seung-Hun Cho, KMD., Ph.D., Principal investigator, Kyunghee University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439111
- Sponsor's protocol ID
- KOMCGIRB-2013-88
- Status last verified
- Feb 2018
- First submitted
- 1 Feb 2018
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Lycium Chinense Fruit Extract Enhances Attention and Cognitive Function in Healthy Young People: A Double-blind, Randomized, Placebo-Controlled, Crossover Trial
- ClinicalTrials.gov ID
- NCT03439111
- Acronym / sponsor ID
- KOMCGIRB-2013-88
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Lycium chinense fruit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- BiomixIndustry (pharma, biotech, devices)
- Collaborators
- Kyunghee University
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 30 Apr 2013 (actual)
- Study completion
- 30 Apr 2013 (actual)
- First posted
- 20 Feb 2018 (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.
Lycium chinense fruit (LCF) is widely distributed in East Asia that has been used traditionally for anti-aging purposes. This study was performed to examine the effects of LCF on attention and cognitive function in healthy young people. An 11-week, double-blind, randomized, placebo-controlled, crossover trial was conducted.
Detailed description
The Computerized Neurocognitive function Test (CNT), the Korean version of the Attention-deficit/hyperactivity disorder (ADHD) Rating Scale-IV (K-ADHD-RS-IV), the Clinical Global Impression (CGI) rating scale, the Frankfurt Attention Inventory (FAIR), and resting-state electroencephalogram (EEG) were conducted before and after the experiment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants receive one of two (or more) alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Standardized Lycium chinense Fruit Extract (LCF) capsulesIntervention : Placebo + Standardized Lycium chinense Fruit Extract (LCF) capsules Placebo Comparator : Oral administration, 600 mg two capsules (600 mg of Starch/capsule) three times a day for 4 week treatment 3 week wash-out Experimental : Oral administration, 600 mg two capsules (146 mg of the Standardized Lycium chinense Fruit Extract (LCF)/capsule) three times a day for 4 week treatment |
| Experimental | Experimental | Dietary Supplement: Standardized Lycium chinense Fruit Extract (LCF) capsulesIntervention : Standardized Lycium chinense Fruit Extract (LCF) capsules + Placebo Experimental : Oral administration, 600 mg two capsules (146 mg of the Standardized Lycium chinense Fruit Extract (LCF)/capsule) three times a day for 4 week treatment 3 week wash-out Placebo Comparator : Oral administration, 600 mg two capsules (600 mg of Starch/capsule) three times a day for 4 week treatment |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age between 14 and 24 years old
- Male or female
- Ability to understand the objectives of the study and agreed to abide by the required rules during the study.
- If participants were aged between 14 and 20 years old, they and their parents had to provide informed consent.
Key exclusion criteria (7 listed)
- Diagnosis of ADHD (any subtype) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
- Diagnosis of a developmental disorder
- Pregnant or breastfeeding women and women with the possibility of getting pregnant
- Gastrointestinal disease or history of gastrointestinal surgery, which might affect the absorption of study materials
- Significant neurological (epilepsy, mental retardation, or stroke) or medical illnesses (diabetes, hypertension, or cardiovascular diseases),
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 |
|---|---|---|
| Standardized Lycium chinense Fruit Extract (LCF) capsulesAll dried water extracts and capsules of the Standardized Lycium chinense Fruit Extract (LCF) and Standardized Lycium chinense Fruit Extract (LCF)-matched placebo capsules used in the present study were manufactured and provided by the BIOMIX Company (Ilsan City, Korea). | Dietary supplement | Experimental, Placebo |
Primary outcome
The Computerized neurocognitive Function Test (CNT)
Time frame: Before treatment, 4 and 11 weeks after treatment
Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment
4 secondary outcomes
Korean version of Attention-deficit/hyperactivity disorder (ADHD) Rating Scale-IV (K-ADHD-RS-IV)
Time frame: Before treatment, 4 and 11 weeks after treatment
The Clinical Global Impression (CGI) rating scale
Time frame: Before treatment, 4 and 11 weeks after treatment
The Frankfurt Attention Inventory (FAIR)
Time frame: Before treatment, 4 and 11 weeks after treatment
Resting-state electroencephalogram (EEG)
Time frame: Before treatment, 4 and 11 weeks after treatment
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 23 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Seung-Hun Cho, KMD., Ph.D. principal investigator
Kyunghee University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Lycium chinense Fruit Extract (LCF) capsules in people with Attention Deficit Hyperactivity Disorder, run by Biomix 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 4 inclusion and 7 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 23 Feb 2018. 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?
The Computerized neurocognitive Function Test (CNT) (time frame: Before treatment, 4 and 11 weeks after treatment). 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 23 Feb 2018.