Clinical trial NCT06055543: Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients
Official title: Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Malnutrition
Cancer
Inflammatory Bowel Diseases
Chronic Obstructive Pulmonary Disease (COPD)
Hiv
Lead sponsor: Danone Specialized Nutrition
Sponsor class: INDUSTRY
First posted: 2023-09-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare nutritional outcomes in terms of percentage of weight gain between a new planted-based high-energy ONS and a standard high-energy ONS with animal protein (cow's mil protein) in patients at malnutrition according to Global Leadership Initiative on Malnutrition (GLIM) criteria.

Detailed description: Due to the increasingly pressing need to develop an oral nutritional supplement (ONS) that does not contain animal ingredients, Fortimel PlantBased, suitable for patients with Disease-Related Malnutrition or who wish to avoid or reduce the consumption of animal products for dietary or lifestyle reasons, is being promoted. At the same time, it is also a therapeutic option to be considered in the population with allergy or intolerance to cow's milk protein. Therefore, the aim is to offer an adapted therapeutic nutritional solution that guarantees nutritional results that are not inferior than ONS with animal protein (cow's milk protein).

This study was designed as an open-label randomized controlled non-inferiority trial with two arms: a new planted-based ONS (Fortimel PlantBased) as the intervention arm and standard ONS (Fortimel Energy) as the control arm, both high-energy formulas (1.5 kcal/m; 200ml).

The study will be carried out in patients at malnutrition according to Global Leadership Initiative on Malnutrition (GLIM) criteria, who need to supplement their diet by taking a high-energy ONS for at least 12 weeks. These patients will be treated and follow-up by the Endocrinology and Nutrition services of 6 public hospitals in Spain.

Eligibility 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

Primary outcomes:
measure: Change in weight
timeFrame: Changes between baseline and final visit (12 weeks).
measure: Improvement in nutritional status
timeFrame: From the baseline to the final visit (12 weeks)
Secondary outcomes:
measure: Change in muscle strength
timeFrame: From the baseline to final visit (12 weeks)
measure: Change in calf circumference
timeFrame: From baseline to final visit (12 week)
measure: Percentage of compliance
timeFrame: During the study follow up
measure: Changes in the gastrointestinal symptom scale (GSRS)
timeFrame: From the baseline to final visit (12 week)
measure: ONS Satisfaction
timeFrame: Final visit (12 week)
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
city: Madrid
country: Spain
facility: Hospital Universitario de Móstoles
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valladolid
country: Spain
facility: Hospital Clínico Valladolid
Study officials:
References: