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ENROLLING BY INVITATION
NCT07821060
NA

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

Sponsor: Spanish National Research Council

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-03-01

Completion Date

2027-12-30

Last Updated

2026-09-15

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Circadian fasting

12 consecutive weeks of circadian fasting consisting in 10/12-hour eating window and 14/12-hour fasting

Locations (1)

Iata-Csic

Paterna, Valencia, Spain