Chronobiology and Home Parenteral Nutrition Study. CHRONO-HPN Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have been receiving nighttime home parenteral nutrition (NPN) for at least two consecutive months.

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.

Disqualifiers

Known sleep or circadian rhythm disorders.

Use of melatonin for sleep.

Trial design

Design model

Single group

Treatments tested in this trial

  • Patient recieving home parenteral nutrition

    Other intervention

    * 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Experimental HPN: Parenteral NutritionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes in Circadian Gene Expression

Measurement of mRNA expression levels of clock genes (via RT-PCR from oral mucosa samples)

Time frame
From baselilne to 24 hours for 4 days
2

Changes in Hormonal Rhythmicity - melatonin

Melatonin measured in pg/ml in saliva

Time frame
From baselilne to 24 hours for 4 days
3

Changes in Hormonal Rhythmicity - cortisol

Cortisol measured in µg/dl in saliva

Time frame
From baselilne to 24 hours for 4 days

Secondary outcomes

1

Changes in Sleep-Wake Cycle and Circadian Rhythm Alignment

Assessed via actigraphy and continuous glucose monitoring

Time frame
From baselilne to 24 hours

Other outcomes

Sponsors and contacts

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