Skip to content

DataLookout

Sign in Start free

CronoNutriBiomNCT07821060

Developing Microbiome and Dietary Strategies Based on Chrono-nutrition for Targeting ADHD

StatusEnrolling by Invitation

PhaseNot applicable

SponsorSpanish National Research Council

Primary completionDec 30, 2026 (estimated)

Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 1 version: 1 with changes below.

Sep 10, 2026 Study First Submitted

Endpoints

Primary

Change in Adult ADHD Quality of Life (AAQoL) total score

Timeframe: Baseline to 12 weeks (end of intervention)

Change in sleep efficiency assessed by daily sleep diary

Timeframe: Baseline to 12 weeks (end of intervention)

Change in total sleep duration assessed by daily sleep diary

Timeframe: Baseline to 12 weeks (end of intervention)

Change in Conners' Adult ADHD Rating Scales (CAARS) Total Score

Timeframe: Baseline to 12 weeks (end of intervention)

Change in Attention-Deficit/Hyperactivity Disorder Rating Scale IV (ADHD-RS-IV) Total Score

Timeframe: Baseline to 12 weeks (end of intervention)

Change in Pittsburgh Sleep Quality Index (PSQI) Global Score

Timeframe: Baseline to 12 weeks (end of intervention)

Change in mid-sleep on free days corrected for sleep debt (MSFsc) derived from the Munich Chronotype Questionnaire (MCTQ)

Timeframe: Baseline to 12 weeks (end of intervention)

Change in salivary cortisol concentration

Timeframe: Baseline to 12 weeks (end of intervention)

Secondary (16)

Change in Barratt Impulsiveness Scale Version 11 (BIS-11) Total Score

Clinical Global Impression-Improvement (CGI-I) Score at week 12

Proportion of participants achieving ≥80% adherence to the assigned intervention

Change in relative abundance of selected gut microbial taxa assessed by 16S rRNA gene sequencing

Change in gut microbial alpha diversity assessed by 16S rRNA gene sequencing

Show 11 moreShow less

Change in gut microbial beta diversity assessed by 16S rRNA gene sequencing

Change in fecal short-chain fatty acid concentrations

Changes in fecal calprotectin

Changes in serum lipid profile biomarkers

Change in serum corticotropin (ACTH) concentration

Changes in serum protein biomarkers

Change in serum IL6

Changes in serum electrolyte biomarkers

Change in body weight

Changes in Body Mass Index

Change in Transepithelial Electrical Resistance (TEER)

Arms and interventions

Control - ControlNo intervention

Healthy participants continuing their usual diet

Control - FastingExperimental

Behavioral - Healthy participants assigned to the fasting intervention.

ADHD - ControlNo intervention

Participants with ADHD continuing their usual diet

ADHD - FastingExperimental

Behavioral - Participants with ADHD assigned to the circadian fasting intervention

Behavioral: Circadian fasting

Sites

1 site in 1 country

Iata-CsicPaterna, Valencia, Spain

About this trial

Study objectives This project seeks to understand how an intervention based on time-restricted eating (ChronoFeeding or CF) can improve quality of life, behavior, sleep, and gut health in adults with ADHD (Attention Deficit Hyperactivity Disorder) who have alterations in their circadian rhythms. It will also study how this intervention affects biological markers, such as microbiota (gut and saliva bacteria), inflammation, and oxidative stress, in both humans and animal models. Methodology A randomized controlled pilot study will be conducted with 60 adults diagnosed with ADHD, aged between 18 and 65, who have extended eating habits (more than 14 hours a day) and sleep problems. People with chronic diseases, recent use of antibiotics (\< 6 months), or supplements that affect metabolism or sleep will be excluded. Participants will be divided into two groups: * Control group: will continue with their usual eating habits. * CF group: will reduce their eating window to 10 hours (breakfast between 9:30-10:00 a.m. and dinner between 7:30-8:00 p.m.), without changing what or how much they eat. For 12 weeks, adherence to the schedule will be assessed using food diaries and validated questionnaires on dietary habits. Clinical analyses will be performed before and after the intervention, including weight, sleep quality (measured using diaries), and psychological scales to assess symptoms of ADHD, anxiety, depression, and quality of life. Fasting blood samples will also be taken to analyze metabolic, hormonal, and inflammation markers. Factors such as the menstrual cycle, stress, environment, and medical history will be studied to better understand the effects of the intervention.

Trial details

Enrollment: 60 participants (estimated)
Started: Mar 1, 2024
Study completion: Dec 30, 2027 (estimated)
Eligibility: 18 to 65, all sexes, healthy volunteers accepted
Design: Interventional, randomized, single blind, basic science
Oversight: Data monitoring committee
Conditions: Attention Deficit Disorder with Hyperactivity, Psychological Well-Being, ADHD, ADHD - Attention Deficit Disorder With Hyperactivity
Collaborators: Hospital Universitario Doctor Peset, Institute of Agrochemistry and Food Technology, National Research Council, State Research Agency, Spain
First posted: Sep 15, 2026
Registry updated: Sep 15, 2026
Last verified: Sep 2026

Related trials at risk

View on ClinicalTrials.gov ↗