Protocol summary

Study aim
Determining the effects of the super-food NBS supplement on the symptoms of hyperactivity and attention deficit hyperactivity disorder in adults with ADHD Determining the effects of the super-food NBS supplement on appetite in adults with ADHD
Design
A controlled clinical trial, with parallel, double-blind, randomized groups, on 50 adult patients with ADHD. We use the rand function in excel software for randomization.
Settings and conduct
The study site is a child and adolescent psychiatric clinic. 18 years and older Individuals who have been diagnosed with ADHD based on DSM 5 criteria and SADS diagnostic interview will complete the ADHD questionnaire and appetite questionnaire at the first visit after obtaining informed and free consent to participate in the study. Then they are randomly divided into two groups of super-food NBS or placebo. The psychiatrist's treatment of choice is not interrupted during the study. Assignment to groups is blinded to the researchers and patients by coding the NBS supplement and the placebo groups.
Participants/Inclusion and exclusion criteria
- Inclusion criteria: Diagnosis of ADHD by a psychiatrist based on ِDSM-5 diagnostic criteria, age 18 years and older - Non-inclusion criteria: celiac disease, dissatisfaction to participate in the study
Intervention groups
In the intervention group, 5 grams of wheat germ powder supplement (produced by Super Food NBS) will be received daily. In the control group, 5 grams of placebo similar to wheat germ powder (produced by Super Food NBS) is received daily.
Main outcome variables
Symptoms of hyperactivity and inattention; Appetite

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140203016465N6
Registration date: 2020-08-02, 1399/05/12
Registration timing: registered_while_recruiting

Last update: 2020-08-02, 1399/05/12
Update count: 0
Registration date
2020-08-02, 1399/05/12
Registrant information
Name
Seyed-Ali Mostafavi
Name of organization / entity
Psychiatry Research Center/ Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 2002
Email address
mostafavi_a@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-20, 1399/04/30
Expected recruitment end date
2020-12-11, 1399/09/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of the NBS super-food dietary supplement on the symptoms of hyperactivity, attention deficiency, and appetite in adults with ADHD compared to placebo
Public title
Evaluating the effects of the NBS super-food on symptoms of ADHD
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of ADHD by a psychiatrist based on DSM-5 diagnostic criteria Age 18 years and above
Exclusion criteria:
Celiac disease Dissatisfaction with participation in the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization Randomization unit: individual Randomization tools and randomization sequences are determined by excel software. Allocation concealment: Allocation to groups is hidden from the researcher and patients by encoding the NBS supplement and placebo groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is blinded and concealed from the participants, the principal investigator, the psychiatrist, the data collectors, and those evaluating the outcome by coding the NBS supplement and placebo groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs, Tehran University of Medical Sciences
Street address
No. 1, Ghods Street, Keshavarz Avenue, Tehran. Iran
City
Tehran
Province
Tehran
Postal code
1417653911
Approval date
2019-12-12, 1398/09/21
Ethics committee reference number
IR.TUMS.VCR.REC.1398.702

Health conditions studied

1

Description of health condition studied
Attention-deficit hyperactivity disorders
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders

Primary outcomes

1

Description
Score of the Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1): Symptoms Checklist
Timepoint
Baseline, week 4, and week 8
Method of measurement
The adult attention deficiency/hyperactivity rating scale

Secondary outcomes

1

Description
Rating the appetite using the visual analogue scale
Timepoint
Baseline, week 4, week 8
Method of measurement
visual analogue scale for appetite

Intervention groups

1

Description
Intervention group: daily, 5 grams of wheat germ powder supplement (produced by Super Food NBS)
Category
Treatment - Other

2

Description
Control group: daily, 5 grams placebo of wheat germ powder (produced by Super Food NBS)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Private Child and Adolescent Psychiatry Clinic
Full name of responsible person
Mohammad Reza Mohammadi
Street address
No. 107, Second Floor, Aria Street, West Sarv Boulevard, Sarv Square, Saadat Abad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 2206 3508
Email
mohammadimr@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ameneh Ahmadi
Street address
Psychiatry and Psychology Research Center, Roozbeh Hospital, South Kargar Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 5541 3540
Email
pprct@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Psychiatry and Psychology Research Center
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

2

Sponsor
Name of organization / entity
NBS Company
Full name of responsible person
Aref Khalkhali
Street address
No. 94, 7th Baharestan St., Fakoori Blvd., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
1333795914
Phone
+98 51 3868 5721
Email
arfkhlkhaly@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
NBS Company
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Ali Mostafavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Psychiatric Research Center, Roozbeh Hospital, South Kargar Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 5542 1959
Email
mostafavi_a@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Ali Mostafavi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Psychiatric Research Center, Roozbeh Hospital, South Kargar Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 5542 2002
Email
mostafavi_a@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Ali Mostafavi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Psychiatric Research Center, Roozbeh Hospital, South Kargar Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 5542 2002
Email
mostafavi_a@sina.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after individual identifications being removed.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The analyzes used in the article are allowed on the delivered data.
From where data/document is obtainable
Requests for data/documentation should only be sent via email to the developer. Responsible person: Dr. Seyed Ali Mostafavi E-Mail: Mostafavi_a@sina.tums.ac.ir
What processes are involved for a request to access data/document
After receiving the email requesting documents or data files, this information will be sent to the requesting email as soon as possible.
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