Chronobiology and Home Parenteral Nutrition Study. CHRONO-HPN Study

Chronobiology and Chronodisruption in People Receiving Medical Nutritional Therapy and Its Impact on the Quality of Life of Patients and Caregivers. A Descriptive and Interventional Study. Chronumet.

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.

Study Overview

• Status: Recruiting
• Conditions: Patients With Home Parenteral Nutrition
• Intervention / Treatment: Other: Patient recieving home parenteral nutrition

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francisca Rodríguez, PhD; Phone Number: 951290343/951030117; Email: paqui.endocrino@gmail.com
• Study Contact Backup: Name: Gabrie, MD; Phone Number: 951290343/951030117; Email: gabrielm.olveira.sspa@juntadeandalucia.es

Study Locations

• Spain
  • Málaga
    • Málaga, Málaga, Spain, 29009
      • Recruiting
      • Hospital Regional Universitario de Málaga, FIMABIS
      • Contact: Gabriel Olveira Fuster, MD; Phone Number: 951290343/951030117; Email: gabrielm.olveira.sspa@juntadeandalucia.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental HPN: Parenteral Nutrition	Other: Patient recieving home parenteral nutrition; Transition from nocturnal PN to daytime PN (9 AM to 9 PM) for 4 consecutive days.; A four-day washout period where the nocturnal PN (9PM to 9AM) regimen is reinstated.; A final 4-day phase where melatonin supplementation (0.5 mg sublingual drops at 8 PM) is introduced while maintaining nocturnal PN.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Circadian Gene Expression	Measurement of mRNA expression levels of clock genes (via RT-PCR from oral mucosa samples)	From baselilne to 24 hours for 4 days
Changes in Hormonal Rhythmicity - melatonin	Melatonin measured in pg/ml in saliva	From baselilne to 24 hours for 4 days
Changes in Hormonal Rhythmicity - cortisol	Cortisol measured in µg/dl in saliva	From baselilne to 24 hours for 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Sleep-Wake Cycle and Circadian Rhythm Alignment	Assessed via actigraphy and continuous glucose monitoring	From baselilne to 24 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Parenteral Nutrition; Chronobiology; Biological rhythms
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hyperphagia
• Other Study ID Numbers: CHRONO-HPN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No