Effects of carnosine supplementation on autism disorder

Effects of carnosine supplementation on plasma melatonin, oxytocin and advanced glycation and precursors of lipoxidation end products levels and sleep and gasterointestinal disorders in children with autism disorder

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016061711689N5

Enrollment

Registered

2016-07-08

Start date

2016-06-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism disorder. Childhood autism

Interventions

Intervention 1: Intervention group: Intake of Carnosine 500 mg capsule once a day with lunch, prepared by Nova nutritions, for 8 weeks. Intervention 2: Placebo group: Intake of Placebo capsule contain

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

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.

Eligibility

Sex/Gender

All

Age

4 Years to 16 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: diagnosis of Autism by psychologist; age between 4-16 years old; tend to cooperation; unchanged method of medical treatment since two months before intervention and through out follow up time; not receiving other supplements; mental retardation. Exclusion criteria: any type of Chelator drugs consumption in study duration; following special diets; neurological diseases like epilepsy, Cerebral Palsy and...; all types of metabolic disorders; medical treatment method alteration during study period; disinclination to start or to continue cooperation; acceptance rate less than 75 percent.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sleep disorders. Timepoint: Beginning and eighth week of the study. Method of measurement: CSHQ questionnaire.;Gastrointestinal disorders. Timepoint: Beginning and eighth week of the study. Method of measurement: ROME3 questionnaire.;Plasma levels of Melatonin. Timepoint: Beginning and eighth week of the study. Method of measurement: ELISA.;Plasma levels of Oxytocin. Timepoint: Beginning and eighth week of the study. Method of measurement: ELISA.;Autism disorder severity. Timepoint: Beginning and eighth week of the study. Method of measurement: GARS questionnaire.	—

Measure

Time frame

Sleep disorders. Timepoint: Beginning and eighth week of the study. Method of measurement: CSHQ questionnaire.;Gastrointestinal disorders. Timepoint: Beginning and eighth week of the study. Method of measurement: ROME3 questionnaire.;Plasma levels of Melatonin. Timepoint: Beginning and eighth week of the study. Method of measurement: ELISA.;Plasma levels of Oxytocin. Timepoint: Beginning and eighth week of the study. Method of measurement: ELISA.;Autism disorder severity. Timepoint: Beginning and eighth week of the study. Method of measurement: GARS questionnaire.

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Secondary

Measure	Time frame
Height. Timepoint: Beginning and eighth week of the study. Method of measurement: Seca stadiometer.;Weight. Timepoint: Beginning and eighth week of the study. Method of measurement: Seca scale.;Body Mass Index. Timepoint: Beginning and eighth week of the study. Method of measurement: (weight/(Height)2).;Hyperactivity. Timepoint: Beginning and eighth week of the study. Method of measurement: Conners questionnaire.	—

Measure

Time frame

Height. Timepoint: Beginning and eighth week of the study. Method of measurement: Seca stadiometer.;Weight. Timepoint: Beginning and eighth week of the study. Method of measurement: Seca scale.;Body Mass Index. Timepoint: Beginning and eighth week of the study. Method of measurement: (weight/(Height)2).;Hyperactivity. Timepoint: Beginning and eighth week of the study. Method of measurement: Conners questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Sorayya kheirouri

Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences

kheirouris@tbzmed.ac.ir+98 41 3335 7580

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026