PRO-PLANTPlant-Based Nutritional Supplement for Malnutrition Risk
Test Product: Plant based high energy high protein ONS
+ Control Product: Dairy based high energy high protein ONS
Supportive Care Study
Summary
Study start date: March 17, 2025
Actual date on which the first participant was enrolled.This study focuses on improving nutritional intake for individuals who are either suffering from or at risk of malnutrition due to disease. It aims to determine whether a plant-based, high-energy, high-protein oral nutritional supplement can help these patients meet their dietary needs. The target group includes people who may not be receiving adequate nutrition because of their medical condition. This research is important as it explores a potential way to enhance the health and recovery of patients by ensuring they get enough nutrients, which is crucial for their overall well-being. Participants in the study will consume the nutritional supplement twice a day for eight weeks, with one serving recommended in the morning and another in the afternoon or evening between meals. The study lasts around 11 weeks for each participant, including a screening period, the supplement intervention, and a follow-up phone call. Blood samples are collected at the start and towards the end of the study to evaluate the effects of the supplement. By monitoring these samples, researchers aim to assess the nutritional changes and benefits provided by the supplement.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Identified as at medium or high risk of malnutrition based on: 1. MUST score ≥ 1 and / or 2. Being prescribed with ONS and willing and able to switch from pre-study prescribed ONS to the Test or Control Product for participation in the study 3. In need of 2 servings of ONS/day (400 kcal; 20 gr protein per serving) for at least 8 weeks as determined by the treating healthcare professional. 4. Medically and physically able to consume high energy high protein ONS in the opinion of the Investigator. 5. Willing to maintain dietary habits for the duration of the study. 6. Willing to consume plant based as well as dairy based ONS Exclusion Criteria: 1. Known allergy to soy, cow's milk protein or to any other ingredients as listed in the study product composition (refer to the product information brochure (PIB) and the appendix of this protocol). 2. Known intolerance to any ingredients as listed in the study product composition (refer to PIB and appendix of this protocol). Subjects with lactose intolerance who use lactase may still be enrolled in the study. 3. Any contraindication to oral feeding per se, including gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intraabdominal sepsis. 4. Active flare of inflammatory bowel disease as defined by Harvey-Bradshaw Index (HBI) \>6 (Crohn's disease) or Simple Clinical Colitis Activity Index (SCCAI) \>5 (ulcerative colitis). 5. Requiring a protein restricted diet as confirmed by a physician, for example chronic kidney disease stage 4 and 5 (estimated by Glomerular Filtration Rate \<30 mL/min/1.73 m2). 6. Requiring enteral nutrition (via tube delivery) or parenteral nutrition. 7. Subjects following a vegan diet.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
QClinical
Rotterdam, Netherlands