Chronobiology and Home Parenteral Nutrition Study. CHRONO-HPN Study

NCT07554703 | Recruiting

• 1 other identifier: CHRONO-HPN
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With Home Parenteral Nutrition

Keywords

Chronobiology; Parenteral Nutrition; Biological rhythms

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Changes in Sleep-Wake Cycle and Circadian Rhythm Alignment

  From baselilne to 24 hours

Study Arms (1)

Experimental HPN: Parenteral Nutrition

EXPERIMENTAL

Other: Patient recieving home parenteral nutrition

Interventions

Patient recieving home parenteral nutrition OTHER

* 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.

Experimental HPN: Parenteral Nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital Regional Universitario de Málaga, FIMABIS

Málaga, Málaga, 29009, Spain

RECRUITING

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Francisca Rodríguez, PhD

CONTACT

951290343/951030117; paqui.endocrino@gmail.com

Gabrie, MD

CONTACT

951290343/951030117; gabrielm.olveira.sspa@juntadeandalucia.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: For Patients Receiving Home Parenteral Nutrition: * Phase 1: Transition from nocturnal to daytime administration of parenteral nutrition for four consecutive days. * Washout Period: A neutral phase with the original nocturnal regimen for 4 consecutive days to prevent carryover effects. * Phase 2: Following the washout period, patients will receive melatonin supplementation (0.5 mg sublingual, nightly) for 4 days while maintaining the adjusted nocturnal infusion schedule.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: August 18, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-02

Locations

ES (1)