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

Study acronym: CronoNutriBiom
StatusEnrolling by Invitation
PhaseNot applicable
Started2024-03-01
View on ClinicalTrials.gov ↗
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
NCT Number NCT07821060
Lead Sponsor Spanish National Research Council
Collaborators: Hospital Universitario Doctor Peset, Institute of Agrochemistry and Food Technology, National Research Council, State Research Agency, Spain
Conditions ADHD, ADHD - Attention Deficit Disorder With Hyperactivity
Enrollment 60 participants
Start Date 2024-03-01
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-15