Effects Of Carnosine On Autism

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2016061711689N4
• Date of registration: 2016-12-02
• Prospective Registration: No
• Primary sponsor: Deputy Of Research And Technology Of Tabriz University Of Medical Science, Nutritional Science Resea
• Public title: Effects Of Carnosine On Autism
• Scientific title: Clinical Trials Of ?Effects Of Carnosine Supplementation On Serotonin, Glutamate And Disease Severity In Children With Autism Disorder
• Date of first enrolment: 2016-06-21
• Target sample size: 50
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/11859
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.
• Phase: N/A

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Dr. Sorayya kheirouri
• Affiliation: Nutrition Sciences Faculty, Tabriz University Of Medical Sciences

• Name: Dr. Sorayya kheirouri
• Affiliation: Nutrition Sciences Faculty, Tabriz University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria: diagnosis of Autism by psychologist; age between 6 to 12 years old; unchanged method of medical treatment since two months before intervention and through out follow up time; not receiving other supplements; mental retardation.
Exclusion criteria: consumption of any types of Chelator drugs in study duration; following of special diet; neurological diseases like epilepsy, Cerebral Palsy and...; all types of metabolic disorders; medical treatment method alteration during study period; adherence of supplement less than 75 percent.
Exclusion criteria:

Age minimum: 6 years
Age maximum: 12 years
Gender: Both

Health Condition(s) or Problem(s) studied

autism disorders

Autism Disorder.
autism disorders

Intervention(s)

Placebo group: Intake of Placebo capsule containing 500 mg of starch, which is similar to Carnosine supplement in terms of dosage, color and size, once a day for 8 weeks.

Intervention group: Intake of Carnosine 500 mg capsule once a day with lunch, for 8 weeks.

Intervention 1: Intervention group: Intake of Carnosine 500 mg capsule once a day with lunch, for 8 weeks. Intervention 2: Placebo group: Intake of Placebo capsule containing 500 mg of starch, which is similar to Carnosine supplement in terms of dosage, color and size, once a day for 8 weeks.

Primary Outcome(s)

Autism disorder severity. Timepoint: At Beginning and eighth week of the study. Method of measurement: GARS questionnaire.

Glutamat. Timepoint: at Beginning and eighth week of the study. Method of measurement: HPLC.

Food intake. Timepoint: At Beginning and fourth week and eighth week of the study. Method of measurement: 3 days food intake.

Serotonin. Timepoint: at Beginning and eighth week of the study. Method of measurement: ELISA.

Sleep disorders. Timepoint: At Beginning and eighth week of the study. Method of measurement: CSHQ questionnaire.

Gastrointestinal disorders. Timepoint: At Beginning and eighth week of the study. Method of measurement: ROME3 questionnaire.

Secondary Outcome(s)

Phisical activity. Timepoint: At Beginning and eighth week of the study. Method of measurement: international phisical activity questionnaire.

Source(s) of Monetary Support

Deputy Of Research And Technology Of Tabriz University Of Medical Science, Nutritional Science Resea

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Comittee Of Tabriz University Of Medical Science