Aligning home parenteral nutrition with the body clock
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.
This trial will test whether changing the timing of overnight home parenteral nutrition to better match patients' natural body clocks improves metabolism, sleep, and quality of life for people on home parenteral nutrition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud Academic / other |
| Locations | 1 site (Málaga, Málaga) |
| Trial ID | NCT07554703 on ClinicalTrials.gov |
What this trial studies
Outpatients who have received nighttime home parenteral nutrition for at least two months will be recruited from participating Andalusian centers and the NUPA association and studied at Hospital Regional Universitario de Málaga/FIMABIS. The protocol examines biological rhythms (including clock gene markers), metabolic measures for carbohydrate, lipid and protein metabolism, sleep measures, chronotype, and quality-of-life questionnaires. Eligible participants must be clinically and metabolically stable, able to consent and complete questionnaires, and without recent hospitalization or acute illness. Known sleep/circadian disorders and melatonin use are exclusion criteria, and the study focuses on whether synchronising nutrition timing reduces chronodisruption and related impairments.
Who should consider this trial
Good fit: Ideal candidates are clinically and metabolically stable outpatients who have received nighttime home parenteral nutrition for at least two consecutive months, can provide informed consent and complete questionnaires, and are referred from participating Andalusian hospitals or the NUPA association.
Not a fit: Patients with known sleep or circadian rhythm disorders, those taking melatonin, or those with recent acute illness, hospitalization, transfusion, or major recent changes in diet or activity are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, synchronising parenteral nutrition timing with circadian rhythms could improve metabolic control, sleep quality, and overall well-being for patients on home parenteral nutrition.
How similar studies have performed: Animal studies and small human trials suggest timing of nutrition can affect metabolism and sleep, but applying chronobiology principles specifically to home parenteral nutrition is a relatively novel and limitedly tested approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Málaga, Málaga
- Hospital Regional Universitario de Málaga, FIMABIS — Málaga, Málaga, Spain (Recruiting)
Study contacts
- Study coordinator: Francisca Rodríguez, PhD
- Email: paqui.endocrino@gmail.com
- Phone: 951290343/951030117
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.