New plant-based nutritional supplement for malnourished patients
Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients
This study is testing a new plant-based nutritional supplement to see if it can help malnourished patients just as well as a standard supplement that contains animal protein.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Danone Specialized Nutrition Industry-sponsored |
| Locations | 6 sites (Bilbao and 5 other locations) |
| Trial ID | NCT06055543 on ClinicalTrials.gov |
What this trial studies
This study compares the nutritional outcomes of a new plant-based high-energy oral nutritional supplement (ONS) against a standard high-energy ONS containing animal protein in malnourished patients. It is designed as an open-label randomized controlled non-inferiority trial, where participants will receive either the new supplement or the standard one for at least 12 weeks. The aim is to ensure that the plant-based supplement provides nutritional results that are not inferior to those of the animal protein-based supplement. The study will involve patients from six public hospitals in Spain who meet the Global Leadership Initiative on Malnutrition (GLIM) criteria.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are malnourished according to GLIM criteria and have high energy requirements.
Not a fit: Patients needing ONS due to surgical or acute illness may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a viable nutritional option for malnourished patients who prefer or require a plant-based diet.
How similar studies have performed: While similar studies have explored nutritional supplements, this specific plant-based approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patients ≥ 18 years old
* Malnourished patients according to GLIM criteria
* Patients with a high energy requirement (1.5kcal/ml) requiring the intake of 2 bottles of ONS per day for at least 12 weeks
* Patients presenting any of the following clinical situations:
* Elderly patients requiring oral nutritional support
* Patients with digestive pathology including but not restricted to inflammatory bowel disease, short bowel syndrome, pancreatitis, without active malabsorption and maldigestion.
* Chronic diseases such as COPD, mild to moderate renal disease, HIV
* Oncologic patients with Eastern Cooperative Oncology Group (ECOG) 0-1
* Patients who have given their consent to participate
* Patients who, in the opinion of the physician, have the capacity to answer the study questionnaires themselves or their caregivers
Exclusion Criteria:
* Patients who need ONS due to surgical or acute illness\*
* Patients with known intolerance or allergy to cow's milk, soya or peas
* Patients with hyperthyroidism. Patients with uncontrolled hypothyroidism
* Uncontrolled diabetic patients (HbA1c \>8%)
* Patients requiring enteral nutrition by tube or ostomy
* Patients with moderate and serious renal insufficiency \< 30ml/min/1,73 m2
* Patients who have value creatinine:
* 1,70 mg/dl - 150,31umol/L Men
* 1,50 mg/dl - 132,63umol/L Women
* Patients with levels of haemoglobin \<10 g/dl, transferrin \<150 mg /dl
Where this trial is running
Bilbao and 5 other locations
- Hospital Universitario de Basurto — Bilbao, Spain (Recruiting)
- Hospital Universitario Reina Sofía — Córdoba, Spain (Recruiting)
- Hospital Universitario de Gran Canaria Doctor Negrín — Las Palmas de Gran Canaria, Spain (Recruiting)
- Hospital Universitario de Móstoles — Madrid, Spain (Recruiting)
- Hospital Universitario Virgen del Rocío — Sevilla, Spain (Recruiting)
- Hospital Clínico Valladolid — Valladolid, Spain (Recruiting)
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.