L-theanine + Paraxanthine for ADHD and Autism Spectrum Disorder

Overseen By Chanaka N Kahathuduwa, MD, PhD

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: Texas Tech University Health Sciences Center

Must be taking: Stimulants

Must not be taking: Antidepressants, Antipsychotics, Caffeine

Disqualifiers: Visual, Auditory, Neurological, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 visits

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a combination of L-theanine and paraxanthine (a natural compound related to caffeine) can improve attention, self-control, and overall thinking skills in adults with ADHD (Attention Deficit Hyperactivity Disorder) or ASD (Autism Spectrum Disorder). Participants will take both the real treatment and a placebo (a pill with no active ingredients) in different sessions to compare effects. The trial seeks adults diagnosed by a doctor with ADHD or ASD who aren't on certain medications or have conditions that might interfere with the study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance cognitive health for many.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, especially if they are antidepressants, antipsychotics, or other drugs that could interact with the study substances. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that L-theanine is generally safe, with very few side effects. In one study involving children with ADHD, only one child developed facial tics, which resolved after stopping the treatment.

Less information is available about paraxanthine, a byproduct of caffeine. Since caffeine is commonly consumed and usually safe in moderate amounts, paraxanthine might have similar safety. However, more research is needed to confirm this.

Overall, the combination of L-theanine and paraxanthine appears promising. Participants should be aware of these findings and consider consulting a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using L-theanine and paraxanthine for ADHD and Autism Spectrum Disorder because these compounds offer a fresh approach compared to traditional stimulant medications like methylphenidate and amphetamines. L-theanine, commonly found in tea, is known for promoting relaxation without drowsiness, which could help in managing hyperactivity and attention issues. Paraxanthine, a metabolite of caffeine, provides a milder stimulant effect, potentially improving focus and cognitive function without the side effects often associated with stronger stimulants. Together, these ingredients could offer a more natural and gentler alternative for those with ADHD or ASD, potentially reducing reliance on harsher medications.

What evidence suggests that this treatment might be an effective treatment for ADHD and ASD?

Research has shown that L-theanine, especially when combined with caffeine, can increase alertness, reduce fatigue, and may alleviate headaches. This combination might enhance focus and cognitive skills. For ADHD, L-theanine could alleviate some symptoms, though its overall effect may be modest. In autism spectrum disorder (ASD), some studies suggest that natural antioxidants like L-theanine can help, particularly by reducing anxiety and tics. Early research indicates L-theanine might assist with certain mental health symptoms. However, this trial specifically examines the effects of L-theanine and paraxanthine on ADHD and ASD, and detailed information about its impact is still under evaluation. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

Adults with ADHD and/or ASD who can undergo neuropsychological testing, fMRI scans, and self-report measures. Participants must be able to take part in two trials comparing a placebo with L-theanine and paraxanthine.

Inclusion Criteria

Participants with a dual diagnosis of ASD and ADHD will be recruited but will only be included in the ASD group - their concurrent ADHD diagnosis will be included as an additional variable in exploratory analyses

I am an adult diagnosed with ADHD or ASD.

Exclusion Criteria

Current/past diagnosis of tics or other forms of dyskinesia

Current/past history of smoking and/or alcohol or drug abuse

Subjects with absolute contraindications to undergo MRI after being screened by the TTNI safety screening sheet (Appendix)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive L-theanine and paraxanthine or placebo in a randomized, single-blinded, repeated-measures crossover design

2 visits

2 visits (in-person)

Follow-up

Participants are monitored for cognitive improvements and safety after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• L-theanine and Paraxanthine

Trial Overview The study is examining if L-theanine combined with paraxanthine improves attention and cognition in adults with ADHD or ASD compared to a placebo. It involves two separate but similar trials where participants are randomly assigned to receive either the combination or a placebo.

How Is the Trial Designed?

Group I: Autism spectrum disorder (ASD) Experimental Treatment 2 Interventions

A group of 12 adult males with autism spectrum disorder (ASD) will be enrolled. Each participant will receive both study conditions in a randomized, single-blinded, repeated-measures crossover design: Active Condition: One capsule containing 200 mg L-theanine + 200 mg paraxanthine. Placebo Condition: One capsule containing 400 mg of corn starch. The order of administration will be randomized, with each participant completing both conditions on separate visits (visits 2 and 3).

Group II: Attention deficit hyperactivity disorder (ADHD) Experimental Treatment 2 Interventions

A group of 12 adult males with Attention Deficit Hyperactivity Disorder (ADHD) will be enrolled. Each participant will receive both study conditions in a randomized, single-blinded, repeated-measures crossover design: Active Condition: One capsule containing 200 mg L-theanine + 200 mg paraxanthine. Placebo Condition: One capsule containing 400 mg of corn starch. The order of administration will be randomized, with each participant completing both conditions on separate visits (visits 2 and 3).

Who Is Running the Clinical Trial?

Texas Tech University Health Sciences Center

Lead Sponsor

Trials

107

Recruited

11,500+

Texas Tech University

Collaborator

Trials

89

Recruited

10,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07189442

L-theanine and Paraxanthine for Cognitive Improvement in ... This pilot study will test whether combining L-theanine and paraxanthine improves sustained attention, inhibitory control, and overall ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8794723/

The Cognitive-Enhancing Outcomes of Caffeine and L ... Participants reported a reduction in “headache” and “tired” ratings, while “alert” ratings were increased. Moreover, a significantly positive ...

3. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-06285-y

The effects of L-theanine supplementation on the outcomes of ... The findings from this systematic review suggest that LT supplementation significantly reduced psychiatric symptoms more effectively than control conditions.

4. mdpi.com mdpi.com/2072-6643/17/9/1482

Efficiency of Different Supplements in Alleviating ... These findings suggest that while L-theanine may have beneficial effects on sleep quality, its impact on ADHD-related symptoms may be limited to certain aspects ...

5. withpower.com withpower.com/clinical-trials/for-attention-deficit-hyperactivity-disorder-adhd-near-long-beach-ca?page=2

Attention-Deficit/Hyperactivity Disorder (ADHD) This study involves a long-term outcome study of the Catholic Health Initiative St. Joseph's Children (CHI SJC) program using a randomized control study.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6574559/

L-theanine and Caffeine Improve Sustained Attention ... L-theanine, caffeine and their combination seem to improve sustained attention and overall cognitive performance in children with ADHD.

7. kantoko.com.au kantoko.com.au/articles/adhd-l-theanine

ADHD and L-Theanine: Benefits, Risks, and What ... Safety: L-theanine appears generally safe with minimal side effects, though one child in the ADHD study developed facial tics (resolved after ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03533556?term=AREA%5BNCTIdSearch%5D(NCT00291070%20OR%20NCT03533556)&rank=1

Study Details | Effects of L-theanine and Caffeine on ... Furthermore, there is evidence to suggest that, when taken in combination, L-theanine and caffeine seem to have additive effects in improving attention in ...