Chronobiology and Home Parenteral Nutrition Study. CHRONO... | NCT07554703

Studies
Chronobiology and Home Parenteral Nutrition Study. CHRONO-HPN Study

NCT07554703

Sponsor

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

Status

Recruiting

Last Update Posted

Apr 28, 2026Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Patients With Home Parenteral Nutrition

Interventions

Patient recieving home parenteral nutrition

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 18, 2025Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Apr 21, 2026

First Submission Date that Met QC Criteria

Apr 21, 2026

First Posted Date

Apr 28, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2026

Last Update Posted Date

Apr 28, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental HPN: Parenteral Nutrition	Experimental		Other: Patient recieving home parenteral nutrition

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Francisca Rodríguez, PhD	Contact	951290343/951030117		paqui.endocrino@gmail.com
Gabrie, MD	Contact	951290343/951030117		gabrielm.olveira.sspa@juntadeandalucia.es

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Regional Universitario de Málaga, FIMABIS	Recruiting	Málaga	Málaga	29009	Spain

Condition Browse Module

MeSH Terms

ID	Term
D006963	Hyperphagia

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.