A Phase 4 interventional study of Fortimel in Malnutrition, Cancer and Inflammatory Bowel Diseases, sponsored by Danone Specialized Nutrition. Recruiting at 6 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by Danone Specialized Nutrition · Phase 4, Interventional, and Treatment
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.
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.
1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.
This study's planned enrollment of 140 is above the median of 70 across 770 interventional studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →This is the only study on the registry with Danone Specialized Nutrition as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients ≥ 18 years old
Oncologic patients with Eastern Cooperative Oncology Group (ECOG) 0-1
Exclusion Criteria:
Patients who need ONS due to surgical or acute illness*
Patients who have value creatinine:
Control: high-energy ONS 1.5 Kcal/m 200ml for 90 days
Dietary Supplement: Fortimel
Intervention: high-energy ONS 1.5 Kcal/m 200ml for 90 days
Dietary Supplement: Fortimel
2 bottles/day of the high energy ONS
Change in weight
Change in weight percentage
Time frame: 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.
Time frame: From the baseline to the final visit (12 weeks)
Change in muscle strength
Measured by dynamometry
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
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
Changes in the gastrointestinal symptom scale (GSRS)
Total score
Time frame: 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.
Time frame: Final visit (12 week)
Plan to share: No
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