Impact of Nighttime Parenteral Nutrition on Bone Health and Metabolism
The Effect of Parenteral Nutrition During Nighttime Versus Daytime on Bone Turnover and Energy Metabolism in Intestinal Failure Patients
This study is testing whether getting nutrition through an IV at night or during the day affects bone health and metabolism in adults with chronic intestinal failure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT05868785 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how the timing of parenteral nutrition—either during the night or day—affects bone turnover, glucose metabolism, and sleep patterns in adults with chronic intestinal failure. The study will involve 20 participants who will alternate between receiving nocturnal and daytime parenteral nutrition over two-week periods. Measurements will include glucose variability, nitrogen balance, and expression of clock genes, with a focus on understanding the metabolic implications of nutrition timing. The goal is to identify optimal nutrition strategies to improve health outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults with chronic intestinal failure who have been on home parenteral nutrition for at least five nights a week for over a year.
Not a fit: Patients who have significant renal insufficiency, recent bone fractures, or those using corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved nutritional strategies that enhance bone health and metabolic function in patients with chronic intestinal failure.
How similar studies have performed: While the specific timing of parenteral nutrition is a relatively novel approach, similar studies have shown promising results in other areas of metabolic health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Home parenteral nutrition for at least 5 nights a week * On home parenteral nutrition for more than 1 year * No major changes in parenteral nutrition for 3 months prior to inclusion Exclusion Criteria: * Parenteral infusion for more than 16 h a day * Use of bone modifying drugs in the last 2 years * Bone fractures in the past year * Renal insufficiency (eGFR \< 60 ml/min) * HbA1c ≥48 mmol/ml * Use of corticosteroids * Shift work * Performing intensive exercise (\> 2 hours a day and \> 3 times a week)
Where this trial is running
Amsterdam, North Holland
- Amsterdam University Medical Center — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: M.J.M. Serlie, professor
- Email: m.j.m.serlie@amsterdamumc.nl
- Phone: +31205669111
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.