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

Primary Purpose

Malnutrition, Cancer, Inflammatory Bowel Diseases

Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Fortimel
Sponsored by
Danone Specialized Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario de BasurtoRecruiting
  • Hospital Universitario Reina SofíaRecruiting
  • Hospital Universitario de Gran Canaria Doctor NegrínRecruiting
  • Hospital Universitario de MóstolesRecruiting
  • Hospital Universitario Virgen del RocíoRecruiting
  • Hospital Clínico ValladolidRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fortimel Energy

Fortimel PlantBased

Arm Description

Control: high-energy ONS 1.5 Kcal/m 200ml for 90 days

Intervention: high-energy ONS 1.5 Kcal/m 200ml for 90 days

Outcomes

Primary Outcome Measures

Change in weight
Change in weight percentage
Improvement in nutritional status
Improvement in nutritional status according to the GLIM criteria. A change in classification category from grade 2 of malnutrition to grade 1 or not meet GLIM criteria, as well as a change from grade 1 to not meet GLIM criteria are considered an improvement.

Secondary Outcome Measures

Change in muscle strength
Measured by dynamometry
Change in calf circumference
Percentage of compliance
Taking into account the number of bottles per day taken, the ml of product and the ml left over.
Changes in the gastrointestinal symptom scale (GSRS)
Total score
ONS Satisfaction
Patients satisfaction taking ONS will be considered if a patient indicates a score of at least 8 points for overall satisfaction question.

Full Information

First Posted
September 14, 2023
Last Updated
September 20, 2023
Sponsor
Danone Specialized Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT06055543
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danone Specialized Nutrition

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Cancer, Inflammatory Bowel Diseases, Chronic Obstructive Pulmonary Disease (COPD), Hiv

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fortimel Energy
Arm Type
Active Comparator
Arm Description
Control: high-energy ONS 1.5 Kcal/m 200ml for 90 days
Arm Title
Fortimel PlantBased
Arm Type
Experimental
Arm Description
Intervention: high-energy ONS 1.5 Kcal/m 200ml for 90 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Fortimel
Intervention Description
2 bottles/day of the high energy ONS
Primary Outcome Measure Information:
Title
Change in weight
Description
Change in weight percentage
Time Frame
Changes between baseline and final visit (12 weeks).
Title
Improvement in nutritional status
Description
Improvement in nutritional status according to the GLIM criteria. A change in classification category from grade 2 of malnutrition to grade 1 or not meet GLIM criteria, as well as a change from grade 1 to not meet GLIM criteria are considered an improvement.
Time Frame
From the baseline to the final visit (12 weeks)
Secondary Outcome Measure Information:
Title
Change in muscle strength
Description
Measured by dynamometry
Time Frame
From the baseline to final visit (12 weeks)
Title
Change in calf circumference
Time Frame
From baseline to final visit (12 week)
Title
Percentage of compliance
Description
Taking into account the number of bottles per day taken, the ml of product and the ml left over.
Time Frame
During the study follow up
Title
Changes in the gastrointestinal symptom scale (GSRS)
Description
Total score
Time Frame
From the baseline to final visit (12 week)
Title
ONS Satisfaction
Description
Patients satisfaction taking ONS will be considered if a patient indicates a score of at least 8 points for overall satisfaction question.
Time Frame
Final visit (12 week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hospital Universitario de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia Iglesias, MD
Phone
944 00 60 00
Email
Nataliacovadonga.iglesiashernandez@osakidetza.eus
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfonso Calañas, MD
Phone
957 01 00 00
Email
contentine@gmail.com
Facility Name
Hospital Universitario de Gran Canaria Doctor Negrín
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro L Pablos Velasco, MD
Phone
928 45 00 00
Email
pablos.velasco@gmail.com
Facility Name
Hospital Universitario de Móstoles
City
Madrid
ZIP/Postal Code
28935
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Araceli Ramos, MD
Phone
916 64 86 00
Email
araceli.ramos@salud.madrid.org
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Pablo Garcia Luna, MD
Phone
955 01 20 00
Email
garcialunapp@yahoo.es
Facility Name
Hospital Clínico Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Antonio De Luis Román, MD
Phone
983420000
Email
dluisro@saludcastillayleon.es

12. IPD Sharing Statement

Plan to Share IPD
No

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

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