MalnutritionPhase 4NCT06055543
Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients
A Phase 4 study testing Fortimel in people with Malnutrition and Cancer, run by Danone Specialized Nutrition at 6 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Cancer, Inflammatory Bowel Diseases
- What is being tested?
- Fortimel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 6 sitesSpain
- Study dates
- 9 Aug 2023to 31 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitario de Basurto
Bilbao, 48013
Natalia Iglesias, MD, 944 00 60 00, Nataliacovadonga.iglesiashernandez@osakidetza.eus
- Recruiting
Hospital Universitario Reina Sofía
Córdoba, 14004
Alfonso Calañas, MD, 957 01 00 00, contentine@gmail.com
- Recruiting
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, 35010
Pedro L Pablos Velasco, MD, 928 45 00 00, pablos.velasco@gmail.com
- Recruiting
Hospital Universitario de Móstoles
Madrid, 28935
Araceli Ramos, MD, 916 64 86 00, araceli.ramos@salud.madrid.org
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, 41013
Pedro Pablo Garcia Luna, MD, 955 01 20 00, garcialunapp@yahoo.es
- Recruiting
Hospital Clínico Valladolid
Valladolid, 47003
Daniel Antonio De Luis Román, MD, 983420000, dluisro@saludcastillayleon.es
About this study
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.
Read the 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.
- Conditions
- Malnutrition, Cancer, Inflammatory Bowel Diseases, Chronic Obstructive Pulmonary Disease (COPD), Hiv
- Being tested
- Fortimel
- Medical subject headings
- Malnutrition, Neoplasms, Inflammatory Bowel Diseases, Pulmonary Disease, Chronic Obstructive, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FortimelDietary supplement
2 bottles/day of the high energy ONS
| Study group | Role | What they receive |
|---|---|---|
| Fortimel Energy | Active comparator | Control: high-energy ONS 1.5 Kcal/m 200ml for 90 days Receives: Dietary Supplement: Fortimel |
| Fortimel PlantBased | Experimental | Intervention: high-energy ONS 1.5 Kcal/m 200ml for 90 days Receives: Dietary Supplement: Fortimel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Change in weight percentage
Measured: Changes between baseline and final visit (12 weeks).
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.
Measured: From the baseline to the final visit (12 weeks)
Secondary outcomes (5)
Change in muscle strength
Measured by dynamometry
Measured: From the baseline to final visit (12 weeks)
Change in calf circumference
Measured: From baseline to final visit (12 week)
Percentage of compliance
Taking into account the number of bottles per day taken, the ml of product and the ml left over.
Measured: During the study follow up
Changes in the gastrointestinal symptom scale (GSRS)
Total score
Measured: From the baseline to final visit (12 week)
ONS Satisfaction
Patients satisfaction taking ONS will be considered if a patient indicates a score of at least 8 points for overall satisfaction question.
Measured: Final visit (12 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start9 Aug 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danone Specialized Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055543
- Sponsor's protocol ID
- Fortimel PlantBased Spain 2022
- Status last verified
- Sep 2023
- First submitted
- 14 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iglesias Hernandez NC, Ramos Carrasco A, De Luis Roman DA, de Pablos-Velasco PL, Calanas Continente A, Rodriguez Soto MJ, Lopez-Gomez JJ, Comi-Diaz C, Garcia-Rey S, Perez-Rambla C, Garcia-Luna PP. Effect of a new plant-based high-energy oral nutritional supplement in adult malnourished patients: an open-label, randomized clinical trial. Front Nutr. 2025 Nov 20;12:1667954. doi: 10.3389/fnut.2025.1667954. eCollection 2025.
PubMed 41356829
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients
- ClinicalTrials.gov ID
- NCT06055543
- Acronym / sponsor ID
- Fortimel PlantBased Spain 2022
- Conditions
- Malnutrition, Cancer, Inflammatory Bowel Diseases, Chronic Obstructive Pulmonary Disease (COPD), Hiv
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Danone Specialized NutritionIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fortimel Energy | Active comparator | Dietary Supplement: FortimelControl: high-energy ONS 1.5 Kcal/m 200ml for 90 days |
| Fortimel PlantBased | Experimental | Dietary Supplement: FortimelIntervention: high-energy ONS 1.5 Kcal/m 200ml for 90 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients ≥ 18 years old
- 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
Key exclusion criteria (10 listed)
- Patients who need ONS due to surgical or acute illness*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fortimel2 bottles/day of the high energy ONS | Dietary supplement | Fortimel Energy, Fortimel PlantBased |
Primary outcome
Change in weight
Time frame: Changes between baseline and final visit (12 weeks).
Change in weight percentage
Improvement in nutritional status
Time frame: From the baseline to the final visit (12 weeks)
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.
5 secondary outcomes
Change in muscle strength
Time frame: From the baseline to final visit (12 weeks)
Change in calf circumference
Time frame: From baseline to final visit (12 week)
Percentage of compliance
Time frame: During the study follow up
Changes in the gastrointestinal symptom scale (GSRS)
Time frame: From the baseline to final visit (12 week)
ONS Satisfaction
Time frame: Final visit (12 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Derived from this study: PubMed 41356829Iglesias Hernandez NC, Ramos Carrasco A, De Luis Roman DA, de Pablos-Velasco PL, Calanas Continente A, Rodriguez Soto MJ, Lopez-Gomez JJ, Comi-Diaz C, Garcia-Rey S, Perez-Rambla C, Garcia-Luna PP. Effect of a new plant-based high-energy oral nutritional supplement in adult malnourished patients: an open-label, randomized clinical trial. Front Nutr. 2025 Nov 20;12:1667954. doi: 10.3389/fnut.2025.1667954. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hospital Universitario de Basurto
Bilbao, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Spain
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fortimel in people with Malnutrition and Cancer, run by Danone Specialized Nutrition at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: Changes between baseline and final visit (12 weeks).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06055543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.