Chronobiology and Home Parenteral Nutrition Study. CHRONO-HPN Study

Recruiting now · Not applicable

Conditions studied: Patients With Home Parenteral Nutrition

In brief

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.

Key facts

Study ID

NCT07554703

Run by

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

People needed

20

Starts

2025-08-18

Expected to finish

2027-12-31

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Known sleep or circadian rhythm disorders.
• Use of melatonin for sleep.

Where it is running

• Hospital Regional Universitario de Málaga, FIMABIS — Málaga, Málaga, Spain (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.