NCT07554703 Chronobiology and Home Parenteral Nutrition Study. CHRONO-HPN Study
| NCT ID | NCT07554703 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud |
| Condition | Patients With Home Parenteral Nutrition |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-08-18 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-08-18 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Medical Nutritional Therapy (MNT) is critical for patients with impaired oral intake and is typically administered via parenteral nutrition (PN). Current infusion practices-nocturnal home parenteral nutrition (NHPN)-may induce circadian misalignment (chronodisruption). This misalignment can negatively impact metabolic function, sleep quality, and overall quality of life for both patients and caregivers. Synchronising MNT administration with circadian rhythms may improve metabolic balance, sleep, and patient well-being. Hypothesis: The timing of the administration of Medical Nutritional Therapy via nocturnal home parenteral nutrition (NHPN) in outpatients may induce chronodisruption in biological rhythms (clock genes). This disruption can affect the metabolism of carbohydrates, lipids, and proteins, contributing to morbidity and altering chronotype, quality of life, and sleep patterns.
Eligibility Criteria
Inclusion Criteria: * Participants must have been receiving nighttime home parenteral nutrition (NPN) for at least two consecutive months. Referred from the Regional University Hospital of Málaga (HRUM), Virgen del Rocío Hospital of Seville (HVR), Reina Sofía University Hospital of Córdoba, or the NUPA Association. * Participants must not have suffered any recent acute illnesses. * Participants must not have been hospitalized, received transfusions, or visited the emergency room in the last month. * Participants must not have made significant changes to their diet or physical activity during the last two months. * Participants must provide informed consent (patient or legal representative). * Participants must be able to answer the questionnaires. * Participants must be metabolically and clinically stable. Exclusion Criteria: * Known sleep or circadian rhythm disorders. * Use of melatonin for sleep.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07554703 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Patients With Home Parenteral Nutrition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07554703 currently recruiting?
Yes, NCT07554703 is actively recruiting participants. Contact the research team at paqui.endocrino@gmail.com for enrollment information.
Where is the NCT07554703 trial being conducted?
This trial is being conducted at Málaga, Spain.
Who is sponsoring the NCT07554703 clinical trial?
NCT07554703 is sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. The trial plans to enroll 20 participants.