Rare sugar in the patient with autism

JRCT ID: jRCTs031180411

Registered date:22/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Impairments in social and language skills.Obesty
• Date of first enrollment: 01/04/2019
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Short-term study: the real medicine (D-allulose) and placebo (D-glucose) is first administered to those assigned to group A and B for one month, respectively.After a washout period of one month, as a cross over phase, the real medicine (D-allulose) and placebo (D-glucose) is second administered to those assigned to group B and A for one month, respectively. Each drug dose are prescribed with low (0.2-0.3g/kg/day) and high (0.4-0.6g/kg/day) dose regimen.
Long-term study: after the short-term study for three months, the real medicine (D-allulose) is administered to all participants for six months. The drug dose is prescribed with the same dose regimen of short-term study.

Outcome(s)

• Primary Outcome: Adverse event: condition or frequency of stool, blood examination, weight loss, hypertension, fatigue, anxiety, dizziness, headache, edema.
• Secondary Outcome: Autistic symptom (DSM-5, PARS, CARS2, Sensory Profile, SCQ, SRS2), autistic associated symptom (ABC-J, RBS-R, Vineland2), circadian rhythm, endocrine and metabolic examination (oxytocin, GLP-1), brain function (eye tracker, etc), developmental or intellectual evaluation (WISC-IV, etc)

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

1. The diagnosis for ASD was made based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
2. Parents or legal guardians of the participant provide written informed consent for participation.

Exclude criteria

1. Comorbid severe neurodegenerative, metabolic, and progressive disorder
2. Severe abnormalities of blood or electrocardiogram examination
3. Persistent diarrhea
4. Severe drug or food allergy
5. Those who changed one's medicine related to symptoms of ASD, treatment of liver dysfunction or cholesterolemia within three months
6. Responsible doctors judged a patient inappropriate for the trial

Related Information

• Primary Sponsor: Monden Yukifumi
• Secondary Sponsor: Yamagata Takanori
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology