Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients

Last updated: September 20, 2023
Sponsor: Danone Specialized Nutrition
Overall Status: Active - Recruiting

Phase

4

Condition

Chronic Obstructive Pulmonary Disease (Copd)

Gastrointestinal Diseases And Disorders

Chronic Bronchitis

Treatment

Fortimel

Clinical Study ID

NCT06055543
Fortimel PlantBased Spain 2022
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 2bottles 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 boweldisease, short bowel syndrome, pancreatitis, without active malabsorption andmaldigestion.
  • 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 thestudy questionnaires themselves or their caregivers

Exclusion

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

Study Design

Total Participants: 140
Treatment Group(s): 1
Primary Treatment: Fortimel
Phase: 4
Study Start date:
August 09, 2023
Estimated Completion Date:
May 31, 2024

Study 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.

Connect with a study center

  • Hospital Universitario de Basurto

    Bilbao, 48013
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofía

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria, 35010
    Spain

    Active - Recruiting

  • Hospital Universitario de Móstoles

    Madrid, 28935
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Clínico Valladolid

    Valladolid, 47003
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.