Actively Recruiting
Chronobiology and Home Parenteral Nutrition Study. CHRONO-HPN Study
Led by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Updated on 2026-04-28
20
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Chronobiology and Home Parenteral Nutrition Study. CHRONO-HPN Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have been receiving nighttime home parenteral nutrition (NPN) for at least two consecutive months.
- Referred from the Regional University Hospital of Málaga, Virgen del Rocío Hospital of Seville, 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 will not qualify if you...
- Known sleep or circadian rhythm disorders.
- Use of melatonin for sleep.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Regional Universitario de Málaga, FIMABIS
Málaga, Málaga, Spain, 29009
Actively Recruiting
Research Team
F
Francisca Rodríguez, PhD
CONTACT
G
Gabrie, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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